艾昆纬（IQVIA）：2024临床试验国家优先级研究报告

1、Rethinking Clinical Trial Country PrioritizationENABLING AGILITY THROUGH GLOBAL DIVERSIFICATION JULY202 4Introduction2024 IQVIA and its affiliates.All reproduction rights,quotations,broadcasting,publications reserved.No part of this publication may be reproduced or transmitted in any form or by any

2、means,electronic or mechanical,including photocopy,recording,or any information storage and retrieval system,without express written consent of IQVIA and the IQVIA Institute.The biopharma clinical research ecosystem has been undergoing a significant evolution in the last five years as technological,

3、environmental,societal,regulatory,and geopolitical shifts have re-shaped the clinical trial pipeline of activity and operations.Together these changes have converged to enable the emergence of new global players and in places,these shifts have contributed to execution challenges,delays,capacity conc

4、erns,and ongoing uncertainty resulting in slower clinical development program timelines with impact on patient treatment options and outcomes.With these changes,clinical trial country prioritization has become a critical focus across clinical research stakeholders.This report sets out to characteriz

5、e the need for clinical trial global diversification by assessing trends in enrollment timelines,trial characteristics,and country utilization over the past five years.It examines the recent shifts and consolidation in regional and country clinical trial allocation,including analysis of the role of

6、single-country trials.An analytical approach based on third party data and IQVIA subject matter expert characterization of country attributes is used to identify opportunities for country diversification.This analysis includes an exploration of a small set of countries with high patient recruitment

7、opportunities but varying infrastructure readiness,and highlights opportunities for multi-stakeholder investment to extend clinical research global options.This analysis focuses on broadly-available country-level metrics as a basis for longer-term industry-wide decision-making for expanding the pool

8、 of countries suitable for clinical trials.This work was undertaken recognizing that individual sponsor decisions about country inclusion are based on many factors beyond country readiness,including sponsor and partner capabilities,recent trial enrollment performance,and specific population epidemio

9、logy and standard-of-care considerations,all of which can sway country attractiveness assessments-especially for immediate trial decision-making.The study was produced independently by the IQVIA Institute for Human Data Science as a public service,without industry or government funding.The contribut

10、ions to this report of the IQVIA Global Site Activation team and the IQVIA Country Diversification initiative team and dozens of others at IQVIA are gratefully acknowledged.Find Out MoreIf you wish to receive future reports from the IQVIA Institute for Human Data Science or join our mailing list,vis

11、it iqviainstitute.org.MURRAY AITKEN Executive Director IQVIA Institute for Human Data ScienceREFERENCING THIS REPORTPlease use this format when referencing content from this report:Source:IQVIA Institute for Human Data Science.Rethinking Clinical Trial Country Prioritization:Enabling Agility through

12、 Global Diversification,July 2024.Available from www.iqviainstitute.orgRethinking Clinical Trial Country Prioritization:Enabling Agility through Global DiversificationTable of ContentsOverview 2The need for clinical trial global diversification 5Assessing country attractiveness for trial sites based

13、 on trial types 11Recent trends in reallocating trial sites across regions and countries 16Mapping opportunities according to country attributes 22Using case studies to highlight longer term country opportunities 34Notes on sources 44Methodologies 45References 49About the authors 50About the Institu

14、te 512|Rethinking Clinical Trial Country Prioritization:Enabling Agility through Global DiversificationTHE NEED FOR CLINICAL TRIAL GLOBAL DIVERSIFICATIONClinical trial enrollment durations have been increasing over the past five years across all phases and therapeutic areas,and the average time from

15、 trial start to patient enrollment close for all trials in the pipeline increased by 26%from 2019 to 2023.More specifically,Phase I trial enrollment times increased by 39%,taking an average of five months longer in 2023 than in 2019,Phase II increased by 29%by adding six months,and Phase III increas

16、ed by 16%and took an average of three months longer to recruit patients.This increase in enrollment time has been consistent across all therapeutic areas,with oncology,neurology and cardiovascular showing the greatest enrollment duration increases six months for oncology and five months for neurolog

17、y and cardiovascular between 2019 and 2023.The average number of subjects and the combined average number of enrollment criteria and trial endpoints have also increased over the past five years by 38%and 15%,respectively,and these increases have been spread across therapeutic areas.1 Concurrent with

18、 these increasing trial demands and enrollment timelines,the average number of countries declined 20%and sites per trial declined by 15%.The decrease in country and site utilization have also occurred across therapeutic areas but have been most pronounced in oncology and neurology trials.Emerging bi

19、opharma companies(EBPs)are sponsoring a record high share of trials but are using fewer countries and are more likely than larger companies to run single country trials.EBPs have seen a sharper drop in the number of countries per trial than large pharmaceutical companies(15%versus 10%)in the past fi

20、ve years and are thus a key driver in the overall pipeline country utilization decline.While decreases in country utilization per trial may be driven by operational and strategic focus by sponsors to reduce costs,this trend may also be contributing to longer enrollment times by limiting enrollment s

21、pan per trial and creating recruitment challenges in saturated geographies or therapeutic areas.Recent geopolitical volatility,viral outbreaks,and transition to a multipolar world have contributed to global,regional,and local trial enrollment and execution disruptions and further underscore the need

22、 to enable site and country diversification to alleviate bottlenecks and enable agility.ASSESSING COUNTRY ATTRACTIVENESS FOR TRIAL SITES BASED ON TRIAL TYPESTrial needs and country and site selection are often assessed along therapeutic lines to consider varying enrollment and execution complexity.W

23、hile this works to align some of a site or a countrys patient access and operational capabilities to incoming trials,many of the standard therapeutic areas contain trials with a blend of needs.Trial characteristics including patient volume,medical complexity and visit intensity can be used to define

24、 segments more distinctly than conventional therapy area segmentation.Consideration of the industry clinical trial pipeline through the lens of patient volume,medical complexity,and visit intensity suggests a set of nine categories blended across phase,therapeutic,mechanistic and regulatory driven d

25、ifferences in clinical trial execution.Analysis of trial segments against trial characteristics confirms that each segment is distinct against both complexity and volume metrics and provides a way to examine drivers of enrollment duration and number of countries.Overview2|Rethinking Clinical Trial C

26、ountry Prioritization:Enabling Agility through Global Diversificationiqviainstitute.org|3RECENT TRENDS IN REALLOCATING TRIAL SITES ACROSS REGIONS AND COUNTRIESThere has been a significant rebalancing of global clinical trial activity between regions over the past five years,with a notable move away

27、from Europe and toward China and North America.Through this rebalancing,Western Europe has remained the most utilized region,but the relative share of country-uses has dropped by 21%since 2019 from 32%to 25%.This shift in global trial activity is mostly consistent across all segments and throughout

28、the COVID-19 pandemic years.The increase in China utilization is mainly being driven by an increase in China-headquartered companies sponsoring trials,and specifically with China headquartered companies running single-country trials,especially in Phase I,oncology,and cell and gene therapy.The total

29、number of China headquartered trials using only China sites rose from 18%to 26%of total trials from 2019 to 2023.Concentration of trial activity by country is high with the 10 leading countries being responsible for 58%of the total clinical trial country-uses from 20212023,while the next 10 accounte

30、d for only 19%of the total country-use share.Over the five-year timeframe from 2019-2023,this concentration has been increasing as the top 10 most-used countries share of trial uses increased by 8.6%while the next 40 most used countries decreased by 3%and the remaining 95 countries relative trial-us

31、e decreased by 2%.MAPPING OPPORTUNITIES ACCORDING TO COUNTRY ATTRIBUTESA process to look closely and systematically at which countries can reliably be used to recruit and execute clinical trials can be useful in an environment of shifting country clinical trial capabilities and capacity.Ideally a co

32、untry prioritization process answers a series of questions about the characteristics of a successful country,the relative clinical trial readiness across countries,opportunities for greater or lesser inclusion of countries in clinical trials,and variance by trial type and implications for near-and l

33、ong-term investments across stakeholders.Focus on publicly available metrics and targeted subject matter expert input to describe country infrastructure,clinical infrastructure,and patient availability by country leads to significantly different ordering of analyzed countries across these dimensions

34、,suggesting a tension in drivers of country attractiveness for running clinical trials.A Country Readiness Score that balances country and clinical infrastructure with patient availability creates an integrated ranking and suggests some shifts from current trial utilization.These shifts represent re

35、prioritization opportunities.Trial segments can be grouped to four trial types,which in turn have similar country requirements.Different trial types require slightly different country characteristics,and the country readiness algorithm can be adjusted to align countries to different trial types.Prio

36、ritization of countries using trial type specific analysis and comparing to current utilization patterns identifies country opportunities,which differ across trial types although Japan,Germany and France have larger opportunities There has been a significant rebalancing of global clinical trial acti

37、vity between regions over the past five years,with a notable move away from Europe and toward China and North America.iqviainstitute.org|3Overview4|Rethinking Clinical Trial Country Prioritization:Enabling Agility through Global Diversificationacross all types.Country attributes analysis also highli

38、ghts specific areas for investment focus to enable clinical trial readiness.There are many ways to approach this type of analysis,and the particulars of the approach will vary based on the available data and the specific trials and pipelines being considered.This approach focuses on publicly availab

39、le country focused data to build an independent industry resource and baseline around country characteristics.Other stakeholders may have additional operational data on enrollment performance that also reflects sponsor or CRO capabilities and infrastructure and which can dramatically influence count

40、ry selection assessments especially for immediate trial decision making in the context of a particular trial with a particular partner.Analysis of country capabilities enables sponsors and CROs as well as governments and industry associations to inform near-term country and trial choices,but also to

41、 prioritize and partner around long-term investments to optimize global clinical trial readiness.USING CASE STUDIES TO HIGHLIGHT LONGER TERM COUNTRY OPPORTUNITIESLooking beyond countries with the highest current readiness the top 10 of which account for 60%of todays country utilization allows for fo

42、cus on next tier countries.Denmark,Belgium and Poland are examples of countries with very high operational readiness,but smaller patient availability.These countries represent immediate opportunities for placing trials as long as potential capacity constraints are considered and addressed.Opportunit

43、y tier countries have high patient availability but gaps in operational infrastructure.India,Brazil,and South Africa are examples of countries with high patient availability but operational gaps that prevent them from being utilized in clinical trials in proportion to the patient need.A closer look

44、at clinical research infrastructure related efforts in these countries suggests how opportunities can be recognized in this tier.India presents a significant patient access and affordability opportunity but lags highly utilized countries across most analyzed country infrastructure and clinical infra

45、structure metrics.Recent regulatory streamlining and public-private investments in diabetes and oncology infrastructure are closing operational gaps especially in urban centers creating roadmaps for further development of India for clinical trial delivery.Brazil also has a significant patient access

46、 opportunity but has been limited in clinical trial use by regulatory challenges and lack of consistent infrastructure,including experienced clinician research staff capacity.A recent regulatory law addressing many of the regulatory process concerns,and multiple examples of public-private investment

47、 in clinical research training demonstrate focus targeting mid-and long-term clinical trial readiness in Brazil.South Africa,and more broadly Sub-Saharan Africa,has the potential to enable access for unique pools of patients to participate in clinical trials,and like Brazil and India,has seen signif

48、icant recent focus on enablers of clinical trial readiness.Pan-African efforts like that of the African Medicines Agency seek to harmonize clinical research regulatory policy while multiple public-private investments provide examples of broad capacity building that,with ongoing targeted focus on reg

49、ulatory,training,and technology,has potential to close operational gaps and enable the opportunity in this region.4|Rethinking Clinical Trial Country Prioritization:Enabling Agility through Global Diversificationiqviainstitute.org|5 Clinical trial enrollment has been taking longer over the past five

50、 years;the time from trial start to the end of enrollment has increased by 26%across all phases.This enrollment time trend has been consistent across all therapeutic areas,with oncology,neurology,and cardiovascular showing the greatest enrollment duration increases six months for oncology and five m

51、onths for neurology and cardiovascular between 2019 and 2023.At the same time,the average number of countries and sites per trial have declined by 15%and 20%since 2019 even as clinical trial volume and operational demands have increased by 38%and 15%,respectively.EBPs are sponsoring a record high sh

52、are of trials but using fewer countries and are more likely than larger companies to run single country trials.While decreases in country utilization per trial may be driven by operational and strategic focus by sponsors to reduce costs,this trend may also be contributing to longer enrollment times

53、by limiting enrollment span per trial and reaching restrictions in recruitment capacity in saturated geographies or therapeutic areas.Recent geopolitical volatility,viral outbreaks,and transition to a multipolar world further underscore the need to enable site and country diversification to alleviat

54、e bottlenecks and enable flexibility.Slowing clinical trial enrollment,decreasing country utilization,and geopolitical volatility indicate the need for rethinking clinical trial country prioritization and the opportunity for global diversification.The need for clinical trial global diversification6|

55、Rethinking Clinical Trial Country Prioritization:Enabling Agility through Global Diversification Enrollment duration measured as the time from trial start to enrollment close for all industry-sponsored interventional clinical trials completing enrollment in the past five years has increased across a

56、ll phases in that timeframe.Phase I saw the largest increase of 39%with enrollment taking an average additional five months for trials ending enrollment in 2023 versus 2019.Phase II and Phase III saw 23%and 16%increases,respectively,with Phase II enrollment times increasing by an average of six mont

57、hs over the five-year timeframe.Enrollment times plateaued or decreased slightly across all three phases in 2020 and 2021,consistent with the timing of the pipeline impact of the bolus of COVID-19 trials that contributed to a decrease in average enrollment times even as trials in other therapeutic a

58、reas may have encountered recruitment challenges.Exhibit 1:Enrollment duration in months by phase for all industry interventional clinical trials by enrollment close dateNotes:Enrollment duration is time from trial start to enrollment close and includes actual enrollment durations only.Trials exclud

59、e diagnostics,behavioral therapies,supplements,devices,and medical procedures.THE NEED FOR CLINICAL TRIAL GLOBAL DIVERSIFICATION Enrollment is taking longer across all phases of developmentSource:Citeline Trialtrove,Jan 2024;IQVIA Institute,June 2024.Phase IPhase IIPhase IIIAll phases353025201510202

60、2 2019 2020 2021 2023 Enrollment duration change2019 to 2023Phase IIEnrollment duration monthsEnrollment close date+23%+6 mthsPhase III+16%+3 mthsAll phases+26%+5 mthsPhase I+39%+5 mths iqviainstitute.org|7 Clinical trial enrollment duration increased across all therapeutic areas in the last five ye

61、ars.Oncology enrollment times were the longest of all therapeutic areas across the timeframe,followed by cardiovascular,endocrinology,and neurology.In addition to having the longest enrollment,oncology also saw the largest absolute increase of six months and the third largest relative increase at 19

62、%over the five-year timespan.Increases in enrollment timelines in oncology are likely linked to continued increases in trial enrollment complexity as complex or new mechanisms,including cell and gene therapies,multispecific antibodies,and antibody drug conjugates increase in the trial pipeline.Given

63、 the longer enrollment timelines,continued increase in oncology as a proportion of the pipeline over the 20192023 timeframe is part of the dynamics driving up total pipeline enrollment duration across phases.Neurology had the highest increase in enrollment duration at 39%followed by 28%for cardiovas

64、cular over the same timeframe.The more significant increase in enrollment times for cardiovascular and neurobiology are not driven by significant differences in phase enrollment times or phase makeup of the therapeutic pipelines over the five-year timeframe(not shown),suggesting slower average enrol

65、lment is a function of shifts in trial or environmental operational factors.Exhibit 2:Enrollment duration in months by therapeutic area for all Phase IIII interventional industry clinical trials by enrollment close dateNotes:Enrollment Duration is time from trial start to enrollment close.Includes a

66、ctual enrollment durations only.Trials exclude diagnostics,behavioral therapies,supplements,devices,and medical procedures.THE NEED FOR CLINICAL TRIAL GLOBAL DIVERSIFICATIONEnrollment timelines are increasing across all TAs,with oncology trials driving the longest enrollment over the past 5 yearsSou

67、rce:Citeline Trialtrove,Jan 2024;IQVIA Institute,March 2024.201920234035302520151050CardiovascularImmunologyAll otherInfectious diseaseand vaccinesNeurologyEndocrinologyOncologyEnrollment duration months8%14%14%39%12%28%19%8|Rethinking Clinical Trial Country Prioritization:Enabling Agility through G

68、lobal Diversification The number of subjects and the average number of enrollment criteria and endpoints increased across the pipeline by 38%and 15%,respectively,from 2019 to 2023.Although these increases have occurred with a backdrop of continued increase in the share of oncology trials in the pipe

69、line,both the increase in subject number and especially of inclusion/exclusion criteria has been spread across therapeutic areas.1 Over the same time,the number of sites per trial and the number of countries per trial have decreased by 15%and 20%,respectively.The decrease in number of countries per

70、trial is observed across all therapeutic areas,but in neurology and oncology in particular.1 While decreases in country utilization per trial may be driven by operational and strategic focus by sponsors to reduce costs,this trend may also be contributing to longer enrollment times by limiting the en

71、rollment span per trial and reaching restrictions in recruitment capacity in saturated geographies or therapeutic areas.These trends over the past five years including the period of the COVID-19 pandemic,which was disruptive to all clinical trial stakeholders suggest an opportunity for sponsors to r

72、econsider the balance between risk,time,and cost,and reduce enrollment times by including additional countries in their trial plansExhibit 3:Total number of subjects,enrollment criteria,endpoints,sites,and countries per trial for industry interventional Phase IIII trials,all therapeutic areas Notes:

73、Subjects per trial excludes COVID-19 and Ebola vaccine trials.Trials exclude diagnostics,behavioral therapies,supplements,devices,and medical procedures.Substantial lags have been noted in the reporting of numbers of subjects,sites,and countries;therefore,each has been adjusted in the most recent ye

74、ar(2023)based on historic observations of this data latency.The most recent year is subject to change in subsequent periods.THE NEED FOR CLINICAL TRIAL GLOBAL DIVERSIFICATIONWhile drivers of trial complexity have increased,country and site utilization per trial have decreased over the past 5 yearsSo

75、urce:Citeline Trialtrove,Jan 2024;IQVIA Institute,June 2024.Average enrollment criteria and endpoints/trialAverage subjects/trialTrial start yearTrial start year20232019202020212022Enrollment demand2502402302202102001901801704947454341393735Average sites/trialAverage countries/trial20232019202020212

76、0223.23.13.02.92.82.72.62.52.42.32.22524232221201918171615Site and country utilizationSubjects/Trial+38%(20192023)Enrollment Criteriaand Endpoints/Trial+15%(20192023)Countries/Trial-20%(20192023)Sites/Trial-15%(20192023)iqviainstitute.org|9 Emerging biopharma companies(EBPs)are sponsoring a record h

77、igh share of trials in 2023,with steady growth over the last five years across all phases increasing from 54%of trial activity in 2019 to 62%in 2023.At the same time,EBPs run trials using fewer countries per trial than larger pharmaceutical companies,with the large pharma cohort(those companies with

78、 more than$10Bn in annual global pharmaceutical sales)using nearly three times the number of countries per trial as EBPs in 2023.This trend has held across the last five years,and both EBPs and large pharma companies have seen their country use drop,with EBP country use dropping by 15%and large phar

79、ma country use dropping by 10%.The larger overall drop seen with EBP country use concurrent with increasing share in the pipeline is a key driver in the overall pipeline country utilization decline;the average country utilization for all trials has declined more(21%)than either customer segment as a

80、 function of the increasing number of EBP-sponsored trials in the pipeline.EBPs utilize single-country trials at a higher rate than large pharma across all phases,but most dramatically in Phase II,where 66%of EBP trials were single-country,in contrast to large pharma,where only 30%of their trials ha

81、d sites in a single countryExhibit 4:Trial analysis by customer segment for all industry interventional clinical trialsNotes:Trials exclude diagnostics,behavioral therapies,supplements,devices,and medical procedures.Substantial lags have been noted in the reporting of numbers of subjects,sites,and c

82、ountries;therefore,each has been adjusted in the most recent year(2023)based on historic observations of this data latency.The most recent year is subject to change in subsequent periods.Large companies are those with global prescription sales exceeding$10Bn in the calendar year.Mid-size companies h

83、ave global prescription sales between$5 and$10 billion in the calendar year.Small companies have global prescription sales between$500Mn to$5Bn in the calendar year.Emerging biopharma(EBP)companies are defined as those with either R&D spend$200Mn or prescription sales up to$500Mn.THE NEED FOR CLINIC

84、AL TRIAL GLOBAL DIVERSIFICATIONEBPs are sponsoring more than 60%of trials but using fewer countries and more single country trials than larger companiesSource:Citeline Trialtrove,Jan 2024;IQVIA Institute,June 2024.87%76%66%76%62%30%Single-country trials%of total trialsTrial start yearTrial start yea

85、rTrial start yearEBPLargeAll trialsEBPLargeEBPLargeMid&small20232019202020212022Trial startsCountries/Trial Single country trials%of total trials 2023100%90%80%70%60%50%40%30%20%10%0%202320192020202120227.06.05.04.03.02.01.00.0Phase IPhase IIPhase III100%90%80%70%60%50%40%30%20%10%0%10|Rethinking Cl

86、inical Trial Country Prioritization:Enabling Agility through Global Diversification Over the past five years,global clinical trial disruptions have occurred across multiple dimensions including environmental,geopolitical and economic.The COVID-19 pandemic provides the starkest example of disruption

87、across all dimensions of clinical trial execution,requiring unprecedented geographic and operational agility,and has had an enduring impact on sites,investigators,and patients.As supply chains were being repaired and trials across the globe were being restarted,the Russian invasion of Ukraine in Feb

88、ruary 2022 disrupted healthcare systems and clinical trial operations in two significant trial geographies.Violence struck in October of 2023 in Israel and Palestine,leading to ongoing volatility and disruption in the Middle East,even as sponsors and CROs rebalanced clinical trial operations across

89、eastern Europe.Economically,as systems shift to a multipolar supply chain,an escalation in U.S.and China trade tensions has implications for China-U.S.biotechnology partnerships and business threats for both countries.2 Based on a recent survey of leading economic experts3,technology,societal,geopol

90、itical,and environmental global risks are expected to drive near-and long-term impact to the global economy.The heightened criticality of anticipating,assessing,and responding to global clinical trial operations disruptions puts having an agile process for diversification of global clinical trial op

91、erations front and center to protect the progress of the industry drug development pipeline.Exhibit 5:Recent clinical trial disruptions and ongoing expected global risksTHE NEED FOR CLINICAL TRIAL GLOBAL DIVERSIFICATIONRecent overlapping global clinical trial disruptions are consistent with expectat

92、ions for ongoing risks and uncertainties Recent global clinical trial disruptionsTop 10 risks(World Economic Forum Global Risks Report 2024)“Please estimate the likely impact(severity)of the following risks over a 2-year and 10-year period.”2 years1st2nd3rd4th5th6th7th8th9th10thRiskcategoriesEconomi

93、cEnvironmentalGeopoliticalSocietalTechnologicalMisinformation and distributionExtreme weather eventsSocietal polarizationCyber insecurityInterstate armed conflictLack of economic opportunityInflationInvoluntary migrationEconomic downturnPollution10 years1st2nd3rd4th5th6th7th8th9th10thExtreme weather

94、 eventsCritical change to Earth systemsBiodiversity loss and ecosystem collapseNatural resource shortageMisinformation and distributionAdverse outcomes of AI technologyInvoluntary migrationCyber insecuritySocietal polarizationPollution201920202021202220232024Hamas/Israel conflictIncreasing extreme w

95、eather events COVID-19 pandemicRussia invades UkraineUS/China trade tensionsMultipolar global evolutionSupply chain continuity challenges:Drug shortagesSource:World Economic Forum,Global Risks Perception Survey 20232024:https:/www.weforum.org/publications/global-risks-report-2024/.3 IQVIA Institute,

96、June 2024.iqviainstitute.org|11 Assessing country readiness for clinical trials requires consideration of enrollment and execution complexity,which do not necessarily align to therapy areas.Trial characteristics including patient volume,medical complexity,and visit intensity can be used to define se

97、gments more distinctly than conventional therapy area segmentation.Consideration of the industry clinical trial pipeline through the lens of patient volume,medical complexity,and visit intensity suggests a set of nine categories blended across phase,therapeutic,mechanistic,and regulatory driven diff

98、erences in clinical trial execution.Analysis of trial segments against trial characteristics confirms that each segment is distinct against both complexity and volume metrics and provides a way to examine drivers of enrollment duration and number of countries.Assessing country attractiveness for tri

99、al sites based on trial typesDisparate trial characteristics and site needs result in distinct trial segments that can be the basis for assessing country readiness and potential opportunity for trial sites.12|Rethinking Clinical Trial Country Prioritization:Enabling Agility through Global Diversific

100、ation Country and site selection and investments are often made through the lens of the therapeutic area,with priority given to those sites and countries that have facilities and experience in the relevant therapeutic areas.While this works to align some of a site or countrys patient access and oper

101、ational capabilities to incoming trials,many of the standard therapeutic areas have a blend of needs.Oncology,for example,is a blend of rare and non-rare disease with trials that may have drastically different profiles,ranging from very few patients with very specific biomarker profiles to very high

102、 volume of patients with relatively few enrollment criteria.Taken further,these trials might involve very complex medical interventions and frequent monitoring as in the case of cell and gene therapies,or they might involve a patient-administered oral medication with fewer clinical site visits.Given

103、 these considerations,there is an opportunity to consider the industry pipeline through a different lens and to break it into segments that organize around site and country characteristics to enable operationalization.Consideration of the characteristics that enable trial execution related to volume

104、 and type of patients,the level of clinical trial complexity,and the level of medical complexity for the patients and conditions being tested can be a more useful way to assess countries that are optimized for clinical trial recruitment and execution.Exhibit 6:Illustrative mapping of trial character

105、istics by traditional therapeutic areasASSESSING COUNTRY ATTRACTIVENESS FOR TRIAL SITES BASED ON TRIAL TYPESAssessing country fit for clinical trials requires consideration of trial complexity,which does not necessarily align to therapy areasSource:IQVIA Institute,June 2024.Conventional therapeutic

106、areasTrial characteristicsOncologyCNSEndocrinologyEtc.CardiovasularInfectious diseaseExpectation is that country fit to trials will be driven by country capabilities e.g.,Country population and epidemiology aligns to patient intensity Country clinical trial experience and capacity to support aligns

107、to trial intensity Country medical infrastructure supports level of medical complexityConventional therapeutic areas present a blend of required trial characteristics and are difficult to align to country readiness profilesPatient volumeHigh patient volumeLowpatientvolumeFew I/EMany I/EHealthypatien

108、tComplexpatientFewendpointsFewendpointsPrevalentpatientScarcepatientSimpleMOAComplexMoAVisit intensityMedical complexityiqviainstitute.org|13Exhibit 7:Trial segment characteristic mappingASSESSING COUNTRY ATTRACTIVENESS FOR TRIAL SITES BASED ON TRIAL TYPESTrial characteristics can be used to define

109、segments more usefully than conventional therapy area segmentationTRIAL CHARACTERISTICSTRIAL SEGMENTPATIENT VOLUMEMEDICAL COMPLEXITYVISIT INTENSITYSEGMENT SPECIFIC COUNTRY REQUIREMENTSCOMMON“BASELINE”OPERATING AND CLINICAL CHARACTERISTICSPhase I non-oncologyHighLowLowEfficiency,access to patients,Ph

110、ase I infrastructure Base operating infrastructure:clean water,electricity,digital capabilities Basic clinical trial business infrastructure:functioning supply chain,reasonable tax structure,regulatory infrastructure,and approval and commercialization of standard of care drugs Optimized clinical tri

111、al efficiency:Attractive clinical trial cost structure and regulatory approval timelines Access to the right patients:epidemiology fits I/E profile(includes right local treatment pathways,standard of care,healthcare and drug access)Clinical site capacity:moderate trial competition Focus and investme

112、nt on clinical research enablementPhase II/III Infectious disease and vaccines(IDV)HighMed(varies)LowEfficiency,emergency care access,access to patientsPhase 2/3 primary careHighMed(varies)Med(varies)Efficiency,acute and primary care sites/physiciansBiosimilarsHighMedMedEfficiency,access to patients

113、,mix of acute/primary care and specialty sitesPhase I OncologyMedMedMedScreening,medical infrastructure,experienced specialty sites,access to patientsPhase II/III specialty/biologicsMedHighHighScreening,medical infrastructure,experienced specialty sites/specialists,access to patientsPhase II/III onc

114、ologyMedHighHighScreening,medical infrastructure,experienced specialty sitesRare diseaseLowVariesvariesScreening,Patient ID and support,ability to reach specific patientsCell and Gene Therapy(CAGT)LowHighHighScreening,medical infrastructure,cell and gene laboratory access,experienced specialty sites

115、 Consideration of the industry clinical trial pipeline through the lens of patient volume,medical complexity,and visit intensity suggests a set of categories blended across phase,therapy area and mechanism of action.A set of nine segments allows for useful separation of phase,therapeutic,mechanistic

116、,and regulatory-driven differences in clinical trial execution.At the least intensive end of the spectrum,including Phase I non-oncology and infectious disease/vaccine trials(IDV),categories may require a high number of patients but have relatively simple medical and clinical intensity,thus requirin

117、g a focus on efficiency and access to patients.In the middle of the spectrum,Phase I oncology trials and trials involving biologic molecules administered in specialist offices may require more intensive medical support,staffing and experience while also needing to enable moderate patient access and

118、screening.At the far end of the spectrum,clinical trials for cell and gene therapies and some rare diseases will require intensive patient screening and access to unique patients,highly specialized medical infrastructure,and experienced clinical staff.Across all trial types,there will be common site

119、 and country characteristics that enable clinical trial execution,including basic operational and governmental infrastructure,basic business regulations,optimized clinical trial costs,and mature and well working national regulatory agencies with clear and efficient regulatory processes.Additionally,

120、every trial may have specific competitive,patient,or execution requirements,including very specific epidemiology or line of therapy requirements that supersede segment-based site and country selection.Finally,all trials need to factor in the path to commercialization in selected trial geographies to

121、 address ethical and practical considerations to running a trial with patients who will not have access to the drug after the trial.Source:IQVIA Institute,June 2024.14|Rethinking Clinical Trial Country Prioritization:Enabling Agility through Global Diversification For the purposes of this research r

122、eport,the industry portfolio of all interventional trials in Phase I,II and III was broken into nine mutually exclusive segments to allow consideration of country utilization trends and opportunities through the lens of country characteristics required for trial success.A stepwise filtering process

123、enabled separation of segment characteristics starting with biosimilar trials based on distinct trial characteristics.Cell and gene therapy trials were screened next based on the assumption that the very specific and intensive medical procedures will require unique considerations regardless of phase

124、 or disease area.Phase I oncology followed by Phase II/III oncology were screened next,recognizing that oncology Phase I trials are very different from non-oncology Phase I and can often be part of adaptive trial programs,or are testing efficacy in patients rather than recruiting healthy volunteers.

125、Rare disease trials were next considering that Phase I safety testing may look very different for highly specialized patients and Phase II and III are defined by screening for highly specific patients.The next set of screens segment the remaining non-oncology Phase I trials,followed by Phase II/III

126、IDV,and Phase II/III biologics,finally leaving Phase II/III primary care trials.Applying this screening hierarchy to clinical trial starts in 2023 results in segments that range from 37 for biosimilars to 1,165 for Phase II/III oncology.Exhibit 8:Trial segment screening hierarchy and Phase I-III ind

127、ustry interventional clinical trial volume 2023Notes:Trials exclude diagnostics,behavioral therapies,supplements,devices,and medical procedures.ASSESSING COUNTRY ATTRACTIVENESS FOR TRIAL SITES BASED ON TRIAL TYPESTotal industry activity can be broken into trial segments using a filtering hierarchy f

128、ocused on defining trial attributesSource:Citeline Trialtrove,Jan 2024;IQVIA Institute,June 2024.Segment screening hierarchy1,50005001,000BiosimilarCAGTPhase I oncologyPhase II/III oncologyRare diseasePhase I non-oncologyPhase II/III IDVPhase II/III biologicPhase II/III primaryClinical trial starts

129、by segment 2023BiosimilarCell and Gene TherapyPhase I oncologyOncology Phase II/IIIRare diseasePhase I(all non-oncology)Infectious diseaseBiologicsPrimaryiqviainstitute.org|15 Analysis of trial segments against key trial characteristics including average number of countries,number of patients,number

130、 of sites,enrollment duration,number of inclusion/exclusion criteria and number of endpoints provides a view of the distinctive needs of each trial segment.Each of the nine segments presents a distinct profile when analyzed this way with potential trends emerging when compared to each other.Specific

131、ally,Phase II and III biologic,Phase II and III primary,and biosimilar segments all have higher volume trials by subject number,while Phase II/III oncology have a slightly lower subject number but are aligned with these segments on the number of sites and to a lesser extent,the number of countries.P

132、hase II/III oncology has the highest average number of endpoints and enrollment criteria followed by Phase I oncology and cell and gene therapy segments and all three group to the longest enrollments.The rare disease segment is relatively low on all metrics but takes as long as the primary care and

133、biologics segments to enroll,while also using as many countries as Phase II and III oncology,confirming that rare patient profiles drive complexity as much as other measurable trial characteristicsExhibit 9:Key trial characteristics for industry interventional clinical trials,completing enrollment 2

134、0212023 excluding IDV indexed to 100 by metricNotes:Subjects per trial excludes COVID-19 and Ebola vaccine trials.Trials exclude diagnostics,behavioral therapies,supplements,devices,and medical procedures.Substantial lags have been noted in the reporting of numbers of subjects,sites,and countries;th

135、erefore,each has been adjusted in the most recent year(2023)based on historic observations of this data latency.The most recent year is subject to change in subsequent periods.ASSESSING COUNTRY ATTRACTIVENESS FOR TRIAL SITES BASED ON TRIAL TYPESThe profiles of trials in each trial segment are distin

136、ct across volume-and complexity-related metricsSource:Citeline Trialtrove,Jan 2024;IQVIA Institute,June 2024.BiosimilarCAGTPhase I non-oncologyPhase I oncologyPhase II/III biologicPhase II/III oncologyPhase II/III primaryRare disease1009080706050403020100Number of countriesEnrollment durationCOMPLEX

137、ITYVOLUMENumber ofsubjectsNumber ofsitesInclusionexclusionPrimarysecondaryendpoints16|Rethinking Clinical Trial Country Prioritization:Enabling Agility through Global Diversification There has been significant rebalancing of global clinical trial activity between regions over the past five years,wit

138、h a notable move away from Europe and toward China and North America.Western Europe is the most utilized region across the entire timeframe,but the relative share of country-uses the number of trials with one or more sites in any country in the region relative to the global total-has dropped by 21%s

139、ince 2019 from 32%to 25%.This shift in global trial activity is mostly consistent across all segments and throughout the COVID-19 pandemic years.The increase in China utilization is mainly being driven by a dramatic increase in China-headquartered companies sponsoring trials,especially in Phase I,on

140、cology,and cell and gene therapy trials.Despite the shifts in regional utilization,country concentration remains high with the 10 leading countries responsible for 58%of the total clinical trial country-uses from 2021-2023,while the next 10 accounted for only 19%of the total country-use share.Over t

141、he five-year timeframe from 2019-2023,this concentration has been increasing as the top 10 most-used countries share of trial-uses increased by 8.6%,while the next 40 most used countries decreased by 3%and the remaining 95 countries relative trial-use decreased by 2%.Recent trends in reallocating tr

142、ial sites across regions and countriesTrial sponsors have been reallocating trial sites across regions and countries over the past decade,in part reflecting shifts in the headquarter locations of EBP companies.iqviainstitute.org|17 The global share of total country-uses per region for trials started

143、 in 2023 compared to 2019 reflects a significant amount of shift in regional utilization with Europe,North America,and China as the most utilized regions that have experienced the largest changes.Western Europe is the most utilized region in 2023,with 25%of country-uses occurring in Western European

144、 countries,but the relative share of country-uses has dropped by 21%since 2019 from 32%to 25%.Similarly,Central and Eastern Europe,which was the third most used region by this metric in 2019,is now the fifth largest region for trial activity,and its relative global use share has declined by 33%.A cr

145、itical driver of this European share loss is the growing inclusion of trial sites in China,as China has increased its relative share by 57%over the same period and is now is the third most utilized region up from fifth in 2019.North America(the United States and Canada)remains the second most utiliz

146、ed region with a relative share increase of 17%since 2019.Exhibit 10:Relative global country-use share by global regions for all industry interventional Phase IIII clinical trialsNotes:Trials exclude diagnostics,behavioral therapies,supplements,devices,and medical procedures.Relative country-uses sh

147、are is the number of trials with one or more sites in any country in the region relative to the global total.Analysis excludes trials with no country reporting.RECENT TRENDS IN REALLOCATING TRIAL SITES ACROSS REGIONS AND COUNTRIESCountry utilization has decreased significantly in Europe since 2019,w

148、hile China and North America use has increasedSource:Citeline Trialtrove,Jan 2024;IQVIA Institute,June 2024.2019202335%30%25%20%15%10%5%0%Central&South AmericaChinaNorthAmericaWesternEuropeAsia-PacificCentral&Eastern EuropeSub-SaharanAfricaNorth Africa&Middle EastRelative total country-uses-21%17%57

149、%8%-33%-35%-2%14%18|Rethinking Clinical Trial Country Prioritization:Enabling Agility through Global Diversification Regional country-use share changes are largely consistent across all trial segments,with Western and Central and Eastern Europe showing a mostly steady decline regardless of trial typ

150、e.Exceptions to this may be for rare disease,Phase II and III oncology and Phase II and III biologics,which showed a slight increase in country uses in 2020 followed by a plateau until 2022 before dropping again to drive the total decrease from 2019.This increase and plateau suggest that Western Eur

151、ope may have been somewhat of a haven for trial continuity of more complex trials through the COVID-19 pandemic.Biosimilars also did not follow the general downward European trend in Central and Eastern Europe,where relative use spiked in 2021 and then settled at about 40%of the global relative coun

152、try use in 2023.China relative country-use showed a steady increase across the pandemic years in all trial segments except biosimilars,which lost share to Central and Eastern Europe in 2021 and 2023.Exhibit 11:Relative global country-use share by select global regions and trial segment for all indus

153、try interventional Phase I III clinical trialsNotes:Trials exclude diagnostics,behavioral therapies,supplements,devices,and medical procedures.Relative country-uses share is the number of trials with one or more sites in any country in the region relative to the global total.Analysis excludes trials

154、 with no country reporting.RECENT TRENDS IN REALLOCATING TRIAL SITES ACROSS REGIONS AND COUNTRIESEuropes share of trials has decreased in nearly all trial segments while Chinas share has increased in all but biosimilars since 2019Source:Citeline Trialtrove,Jan 2024;IQVIA Institute,June 2024.Relative

155、 total country-usesTrial start year20232019202020212022Western EuropeChina50%40%30%20%10%0%50%40%30%20%10%0%50%40%30%20%10%0%2023201920202021202220232019202020212022BiosimilarCAGTPhase I non-oncologyPhase I oncologyPhase II/III biologicPhase II/III IDVPhase II/III oncologyPhase II/III primaryRare di

156、seaseCentral and Eastern Europeiqviainstitute.org|19 The increase in Chinas share of clinical trial-uses is being driven by an increase in China headquartered sponsor trials,and specifically with China headquartered companies running single-country trials as shown by analysis of total trial starts b

157、y headquarter location.The total number of China headquartered companies using only China sites rose from 928 to 1,179,or 18%to 26%,of total trials from 2019 to 2023.During the same time,China headquartered companies using ex-China sites(including those with no China sites)accounted for 3%and 4%of t

158、otal pipeline trials in 2019 and 2023,respectively.China headquartered companies running single-country trials in China started 62%of the trials with China sites in 2019 and 72%in 2023,while those running global trials started 3%and 4%over the same timeframe.Companies with headquarters outside of Ch

159、ina were responsible for 35%of China trial starts with sites in China in 2019,dropping to 24%in 2023.Oncology,Phase I non-oncology and cell and gene therapy trial segments saw the most trial starts with China sites from China headquartered companies in 2023.Exhibit 12:Clinical trial starts for all i

160、ndustry interventional Phase IIII clinical trials by headquarter location and China site involvementNotes:China HQ trials include those that are China HQ companies only,or China HQ companies partnered with any ex-China companies;Global trials are trials that include China sites and sites in any ex-C

161、hina country.Trials exclude diagnostics,behavioral therapies,supplements,devices,and medical procedures.Analysis excludes trials with no country reporting.RECENT TRENDS IN REALLOCATING TRIAL SITES ACROSS REGIONS AND COUNTRIESThe increase in China utilization is driven mainly by an increase in China-

162、headquartered companies sponsoring trialsSource:Citeline Trialtrove,Jan 2024;IQVIA Institute,June 2024.Trial startsTrial start yearChina HQ/China sites onlyChina/No China sitesa HQ China HQ/Global sitesEx-China HQ20232019 2020 2021 2022All trials Trials starts with China sites by segment(2023)7,0006

163、,0005,0004,0003,0002,0001,0000100%90%80%70%60%50%40%30%20%10%0%60050040030020010002023BiosimilarPh II/III IDVPh II/III biologicRare diseasePh II/III primaryCAGTPh I non-oncologyPh I oncologyPh II/III oncology2019 2020 2021 2022Trials with China sites20|Rethinking Clinical Trial Country Prioritizatio

164、n:Enabling Agility through Global Diversification IDV,cell and gene therapy,oncology and biologic trial segments had the largest relative regional clinical trial country-use changes with just over 15%of country-uses in IDV and just under 15%change in country-uses in cell and gene therapy,oncology,an

165、d biologics between 2019 and 2023.In IDV,North America gained the most share at 10%,followed by China at a 4%increase while Western and Eastern Europe lost about equal share of 6%each.In each of these segments with the highest shifts,China and Western Europe were the biggest movers with China gainin

166、g between 6%and 13%share across the biologics,oncology and cell and gene therapy segments while western Europe lost between 5%and 12%share.Lesser used regions including Sub-Saharan Africa,North Africa and Middle East,and Central and South America had a mix of small share gains and losses across tria

167、l segments.Notably,Sub-Saharan Africa lost 2.5%share in IDV but gained 3%in biosimilars,1%in non-oncology Phase I,and 0.5%in rare disease,while Central and South America lost 2%in IDV but gained 2.5%and 2%in the biologics and primary care segments.Exhibit 13:Regional share change in country-uses by

168、trial segment 20192023 for all industry interventional Phase I III clinical trialsNotes:Relative country-uses share is the number of trials with one or more sites in any country in the region relative to the global total.Trials exclude diagnostics,behavioral therapies,supplements,devices,and medical

169、 procedures.Analysis excludes trials with no country reporting.RECENT TRENDS IN REALLOCATING TRIAL SITES ACROSS REGIONS AND COUNTRIESNorth America,APAC,and China have gained share as Europes share of trials has declined across all segmentsSource:Citeline Trialtrove,Jan 2024;IQVIA Institute,June 2024

170、.Sub-SaharanAfricaChinaAPACNorth AmericaWestern EuropeCentral and Eastern EuropeCentral and South AmericaNorth Africa and Middle East20.0%15.0%10.0%5.0%0.0%-5.0%-10.0%-15.0%-20.0%Phase II/IIIbiologicCAGTPhaseII/III IDVPhase IoncologyPhase II/IIIoncologyBiosimilarPhase II/IIIprimaryPhase II/IIIoncolo

171、gyRaredisease%Country-use share change 20192023iqviainstitute.org|21 As the clinical trial pipeline has shifted regional country utilization over the past five years,country utilization has undergone a significant consolidation led by increasing United States and China utilization.The top 10 most us

172、ed countries account for 58%of the total average pipeline country use,with the United States and China responsible for 16%and 13%,respectively,of total country-uses for trials started in the 20212023 timeframe.The next 10 countries are 19%of the country-use share,the next 30 are 20%,and the next 95

173、countries account for only 3%of the total country uses in 20212023.Over the five-year timeframe from 20192023,the top 10 most used countries share of trial uses increased by 8.6%,from 55%to 63%,while the next 40 most used countries decreased by 3%and the remaining 95 countries relative trial-use dec

174、reased by 2%.In Europe,the countries with the highest numbers of trial sites Spain,Germany,United Kingdom and France all lost share over the past five years.Exhibit 14:Country participation in industry run interventional Phase I III clinical trials total 20212023 trial use and 2019 to 2023 share cha

175、nge by countryNotes:Trial-use share is total trials per country divided by total number of country trialuses globally.Trials exclude diagnostics,behavioral therapies,supplements,devices,and medical procedures.Analysis excludes trials with no country reporting.RECENT TRENDS IN REALLOCATING TRIAL SITE

176、S ACROSS REGIONS AND COUNTRIESCountry utilization is heavily consolidated in U.S.,China and Western European countriesSource:Citeline Trialtrove,Jan 2024;IQVIA Institute,June 2024.16%United States13%China4%Australia4%Spain4%Canada4%Germany4%United Kingdom3%Japan3%South Korea3%France19%next 10 Italy,

177、Poland,Belgium,Netherlands,India,Argentina,Czech Republic,Hungary,Israel,Brazil 20%next 303%next 958%6%4%2%0%-2%-4%United StatesChinaAustraliaSpainCanadaGermanyUnited KingdomJapanSouth KoreaFranceNext 10Next 30Next 95Trial-use share change 20192023Average 20212023 trial use by countryTrial-use share

178、 change 2019 to 20236.1%4.3%0.9%-0.3%-0.2%-1.0%-1.0%0.1%0.3%-0.6%-3.2%-3.4%-2.0%Top 10 total trial-use share increased 8.6%20192023100%=15,040trial uses22|Rethinking Clinical Trial Country Prioritization:Enabling Agility through Global Diversification A process to look closely and systematically at

179、which countries can reliably be used to recruit and execute clinical trials can be useful in an environment of shifting country clinical trial capabilities and capacity.Ideally a country prioritization process answers a series of questions about the characteristics of a successful country,the relati

180、ve clinical trial readiness across countries,opportunities for greater or lesser inclusion of countries in clinical trials,and variance by trial type and implications for near-and long-term investments.A country readiness score that balances patient access,country infrastructure and clinical capabil

181、ities can be used to create a trial ranking that suggests some shifts from current industry trial utilization.Comparison of rankings to current country utilization levels identifies potential underutilization.Different trial types require slightly different country characteristics and the attractive

182、ness algorithm can be adjusted to align best countries to different trial types.Prioritization of countries using trial type specific analysis and comparing to current utilization patterns identifies country opportunities and highlights specific areas for investment focus to enable clinical trial re

183、adiness.There are many ways to approach this type of process,and the particulars of the analytical approach will vary based on the available data and the specific trials and pipelines being considered.Analysis of country capabilities enables sponsors and CROs as well as governments and industry asso

184、ciations to make near term country and trial choices,but also to prioritize and communicate longer term investments to optimize global clinical trial readiness.Mapping opportunities according to country attributesCountry characteristic analysis surfaces near-and long-term opportunities for adjusting

185、 country utilization.iqviainstitute.org|23 A process to look closely and systematically at which countries can reliably be used to recruit and execute clinical trials can be useful in an environment of shifting country clinical trial capabilities and capacity.Ideally a country prioritization process

186、 would answer a series of questions to enable near-and long-term clinical trial allocation and global investment decisions.Questions include which characteristics a successful country would have,which countries have the highest clinical trial readiness when analyzed by these criteria,which countries

187、 have opportunities for greater or lesser inclusion in clinical trials,how does that vary by trial type,and what might that mean for near-and long-term investments.A process to address these questions would include agreeing upon a set of available metrics to characterize a country,framing an algorit

188、hm that appropriately balances the relative importance of these metrics to indicate trial readiness,comparing readiness scores to current utilization to estimate country opportunity,and interrogating metrics to identify specific areas for improvement for country participation in clinical trials.Ther

189、e are many ways to approach this set of questions and type of process,and the particulars of the analytical approach,and the data used,should and will vary based on the specific trials and pipelines being considered.The critical point is that this sort of an approach can provide analytical rigor and

190、 transparency to the continual monitoring and contextualizing of a highly dynamic clinical trial ecosystem.Exhibit 15:Summary of country opportunity mapping process MAPPING OPPORTUNITIES ACCORDING TO COUNTRY ATTRIBUTESTransparent Country Readiness analysis helps answer questions arising from a dynam

191、ic clinical trial operating environmentSource:IQVIA Institute,June 2024.Which country characteristics enable clinical trials?Clinical Trial Readiness metricsWhich countries rank as most ready when balancingoperational characteristics and patient availability?Clinical Trial Readiness algorithmWhich c

192、ountries could be used more often than they currently are?Country Opportunity rankingHow do country readiness rankings change based on trial types?Trial type readinessWhich characteristics can explain underutilization?Investment opportunitiesHow can sponsors,CROs and countries use this type of metho

193、dology in near and longer-term country planning?Investment horizons24|Rethinking Clinical Trial Country Prioritization:Enabling Agility through Global Diversification An algorithm that balances country infrastructure,clinical capabilities and patient availability can enable evaluation of the relativ

194、e level of country readiness to conduct clinical trials.A set of 17 metrics(Figure 2)for which data are available across over 100 countries were selected to objectively and reliably estimate the ability of a comprehensive set of global countries to meet the operating requirements for a clinical tria

195、l.Operating Infrastructure metrics were selected to characterize the basic operating environment and are considered critical foundational aspects of being able to conduct a clinical trial in a geography,including indicators such as access to clean water,ready access to the internet,streamlined busin

196、ess processes including paying taxes and trading across borders,and fundamental safety and basic government functioning.Clinical Infrastructure metrics focus on country attributes that enable high quality sites with the necessary infrastructure,staff,and experience to meet the medical needs of patie

197、nts in trials as indicated by drug approvals and healthy life expectancy,but also to efficiently administer high quality clinical research as indicated by density of existing experienced clinical sites,average operating costs and national regulatory agency effectiveness and efficiency.Patient Availa

198、bility metrics were selected to estimate the total number of patients available in a country,but also to understand their ability to access a clinical site by approximating their ability to access healthcare facilities and basic care based on the Healthcare Access and Quality Index11 as well as thei

199、r interest in participating in a clinical trial as indicated by the inverse of drug reimbursement and current clinical trial density.Exhibit 16:Algorithm and metrics to characterize country opportunity for running clinical trials Notes:See Methodologies for additional metrics detail.MAPPING OPPORTUN

200、ITIES ACCORDING TO COUNTRY ATTRIBUTESAn algorithm integrating country infrastructure,clinical capabilities and patient availability metrics can highlight country trial readinessSource:IQVIA Institute,June 2024.=Average(CountryReadinessScoreOperational infrastructureClinical infrastructurePatient ava

201、ilability+)XOperational Infrastructure ScoreAccess to waterAccess to internetPaying taxesTrading across bordersSafety and stabilitySound governmentNew drug approvalsHealthy life expectancyActive site densityAffordabilityRegulatory capabilitiesStart-up efficiencyPopulationHealthcare access and qualit

202、y index Number of physiciansPatient need:Inverse new drug reimbursementCompetition:Inverse trial densityPatient Availability ScoreClinical Infrastructure Scoreiqviainstitute.org|25Exhibit 17:Country ranking by readiness algorithm component scoresMAPPING OPPORTUNITIES ACCORDING TO COUNTRY ATTRIBUTESE

203、ach Country Readiness component score prioritizes countries differently demonstrating the need for a way to balance priorities120100806040200OperatingInfrastructure Score120100806040200ClinicalInfrastructure Score120100806040200PatientAvailability Score Switzerland Denmark Netherlands Sweden Norway

204、New Zealand Finland Germany Canada Austria Portugal Singapore Belgium United Kingdom South Korea Japan Ireland France Czech Republic Spain Australia United States Greece Italy Hungary Slovakia United Arab Emirates Poland Chile Romania Bulgaria Costa Rica Malaysia China Vietnam Indonesia Jordan Domin

205、ican Republic Argentina Thailand Brazil South Africa Serbia Mexico Peru India Colombia Guatemala Czech Republic Slovakia Switzerland Spain Denmark Bulgaria Austria Australia Swden Japan Portugal Germany Belgium Finland Unites States France Norway United Kingdom Chile Netherlands Poland Hungary Canad

206、a Singapore Romania Serbia Ireland South Korea Italy New Zealand United Arab Emirates Greece Costa Rica Peru Malaysia Columbia Jordan Argentina Dominican Republic Brizil Thailand Guatemala Mexico China South Africa India Vietnam Indonesia ChinaUnited StatesIndiaBrazilGermanyJapanItalyFranceMexicoSpa

207、inUnited KingdomSouth KoreaArgentinaIndonesiaPolandCanadaAustraliaColombiaVietnamNetherlandsSwedenThailandGreeceMalaysiaBelgiumPortugalChileRomaniaHungaryAustriaPeruSwitzerlandCzech RepublicSouth AfricaNorwayJordanFinlandDenmarkBulgariaIrelandSerbiaUnited Arab EmiratesNew ZealandSlovakiaSingaporeGua

208、temalaCosta RicaDominican RepublicNotes:Only countries with five or more trials per year on average 20212023 and above the 15th percentile for safety and stability metric,governance metric,population and number of physicians were included in the analysis;this notably excludes Israel,Turkey and Ukrai

209、ne on security concerns,and Russia on governance concerns despite significant trial activity in the 20212023 time-frame.All metrics and scores have been scaled to 100.See Methodologies for source detail and additional notes.Ranking countries based on the Operating Infrastructure metrics,the Clinical

210、 Infrastructure metrics and the Patient Availability metrics leads to significantly different ordering of the countries across these dimensions.Operating Infrastructure scoring prioritizes smaller Western European and Nordic countries with Switzerland,Denmark,and the Netherlands scoring highest.Clin

211、ical Infrastructure scoring also prioritizes Europe but includes Central and Eastern as well as Western European countries and Japan in the top 10 with the Czech Republic,Slovakia and Switzerland ranking highest.The Patient Availability Score yields a significantly different ranking from the infrast

212、ructure scores and includes APAC,North America,Latin America and Western Europe in the top 10,led by China,the United States,and India the three nations with the highest populations by a large margin.Notably,India and Brazil,which score in the top 10 for patient availability,score in the bottom quar

213、tile for operating and clinical infrastructure,illustrating an important tension in consideration of clinical trial readiness and clinical trial opportunity.Source:Citeline Trialtrove,Jan 2024;Citeline Sitetrove,March 2024;World Health Statistics4,March 2024;World Bank,Development Indicators DataBan

214、k5,March 2024;World Bank,Doing Business DataBank6,March 2024;World Bank,Worldwide Governance Indicators7,March 2024;PhRMA,Global Access to New Medicines Report,April 20238;ILO Stat explorer9,March 2024;Moore et.al.,JAMA International Medicine,Nov 201810;Healthcare Access and Quality Index 19902019.I

215、nstitute for Health Metrics and Evaluation(IHME),202211;IQVIA Institute,June 2024.26|Rethinking Clinical Trial Country Prioritization:Enabling Agility through Global Diversification The Readiness Score algorithm balances the ability of a country to support quality clinical research with the total po

216、tential number of clinical trial participants by multiplying the Operational and Clinical Infrastructure Scores by the Patient Availability Score to yield a Readiness Score.The integrated Readiness Score provides a ranking of countries but also contextualizes that ranking with an estimate of the num

217、ber of trials that could be run in a geography if todays global clinical trial capacity was reallocated per the Readiness Score.In this configuration of the algorithm,considering a basic balance for metrics referencing the full industry pipeline,countries in North America,Western Europe,Japan,and Ch

218、ina are ranked among the top 10 most ready clinical trial geographies.The United States ranks highest in this scenario,followed by Germany,Japan,and France,and all four have a near even balance of contributing scores.China is ranked fifth in this analysis with a suggested trial capacity on par with

219、Japan and Spain,but a dramatically different set of component scores with a relatively low Infrastructure Score,offset by the highest Patient Availability Score driven by the second largest population on the globe.Sensitivity analysis shows a high dependance of the algorithm on magnitude of populati

220、on and willingness of the patient(not shown)and highlights the importance of thinking through specific objectives of the inquiry and particulars of the trial or portfolio in question to optimally calibrate and interpret model results.Exhibit 18:Readiness algorithm scores and Readiness Score allocate

221、d trials by country all industry interventional Phase IIII trialsNotes:Only countries with 5 or more trials per year on average 20212023 and above the 15th percentile for safety and stability metric,the governance metric,population and number of physicians were included in the analysis;All metrics a

222、nd scores have been scaled to 100.See Methodologies for source detail and additional notes.MAPPING OPPORTUNITIES ACCORDING TO COUNTRY ATTRIBUTESCountry Readiness Score balances the importance of country infrastructure and patient availability to enable clinical trial delivery1,2001,0008006004002000

223、United States Germany Japan France China Spain United Kingdom Italy South Korea Canada Australia Poland Sweden Netherlands Brazil Belgium Portugal India Greece Switzerland Argentina Chile Austria Romania Czech Republic Mexico Hungary Malaysia Colombia Indonesia Norway Thailand Vietnam Finland Peru D

224、enmark Jordan Bulgaria Ireland South Africa New Zealand United Arab Emirates Slovakia Serbia Singapore Costa Rica Guatemala Dominican Republic Number of trials250200150100500Readiness algorithm scoresReadiness Score trial allocation Operating Infrastructure ScorePatient Availability ScoreClinical In

225、frastructure ScoreSource:Citeline Trialtrove,Jan 2024;Citeline Sitetrove,March 2024;World Health Statistics4,March 2024;World Bank,Development Indicators DataBank5,March 2024;World Bank,Doing Business DataBank6,March 2024;World Bank,Worldwide Governance Indicators7,March 2024;PhRMA,Global Access to

226、New Medicines Report,April 20238;ILO Stat explorer9,March 2024;Moore et.al.,JAMA International Medicine,Nov 201810;Healthcare Access and Quality Index 19902019.Institute for Health Metrics and Evaluation(IHME),202211;IQVIA Institute,June 2024.iqviainstitute.org|27Source:Citeline Trialtrove,Jan 2024;

227、Citeline Sitetrove,March 2024;World Health Statistics4,March 2024;World Bank,Development Indicators DataBank5,March 2024;World Bank,Doing Business DataBank6,March 2024;World Bank,Worldwide Governance Indicators7,March 2024;PhRMA,Global Access to New Medicines Report,April 20238;ILO Stat explorer9,Ma

228、rch 2024;Moore et.al.,JAMA International Medicine,Nov 201810;Healthcare Access and Quality Index 19902019.Institute for Health Metrics and Evaluation(IHME),202211;IQVIA Institute,June 2024.Exhibit 19:Readiness Score allocated trials difference to actual 2021-2023 trials by country all industry inter

229、ventional Phase IIII trialsMAPPING OPPORTUNITIES ACCORDING TO COUNTRY ATTRIBUTESRanking countries by the difference between Readiness Score trial allocation and actual trials highlights underutilized countriesReadiness score trial allocationActual trials(Average 20212023)Country opportunity Country

230、opportunity=Readiness score trial allocation actual trial utilizationOperating Infrastructure scorePatient Availability ScoreClinical Infrastructure Score1,2001,0008006004002000-200-400 Japan Germany France Italy Sweden Spain United Kingdom Portugal Chile Indonesia South Korea Brazil Greece Malaysia

231、 Romania Colombia Switzerland Vietnam Austria Jordan Netherlands Poland Peru United Arab Emirates Norway Costa Rica Dominican Republic Guatemala Finland Argentina Mexico Thailand India Ireland Serbia Slovakia Czech Republic Belgium Singapore Canada Hungary South Africa New Zealand Australia Denmark

232、Bulgaria United States China Number of trials250200150100500Readiness algorithm scoresNotes:Only countries with 5 or more trials per year on average 20212023 and above the 15th percentile for safety and stability metric,population and number of physicians were included in the analysis;All metrics an

233、d scores have been scaled to 100.Country opportunity is the difference between the Readiness Score trial allocation and the actual trial utilization by country.See Methodologies for source detail and additional notes.Comparison of Country Readiness Scores to current actual trial utilization for each

234、 of the countries in the analysis yields the Country Opportunity ranking and provides an estimate of under-or over-utilization in the pipeline.Japan is highlighted in this analysis as the largest opportunity because of a very high Country Readiness Score but limited actual use on global trials at le

235、ast partially because of its concentrated ethnicity and requirements for in-country Phase I testing prior use in any later stage trials.This finding highlights a critical point around the importance of contextualizing results from this sort of analysis,although in the case of Japan,an opportunity th

236、at is emerging with relaxation of Phase I regulatory requirements is appropriately being flagged as important to consider given the high scores being delivered across other metrics.Likewise,Western Europe is highly ranked based on opportunity scoring,which may in part reflect a difference between cu

237、rrently reduced trial utilization because of pandemic-era EU and UK regulatory agency delays and recent regulatory process improvements as EU CTR implementation improvements begin to take hold.1 The United States and China both have negative Opportunity scoring suggesting current over-utilization ve

238、rsus relative capabilities which may be at least in part a function of the importance of the U.S.commercial market and the rise in trials coming from China headquartered companies.28|Rethinking Clinical Trial Country Prioritization:Enabling Agility through Global DiversificationExhibit 20:Framework

239、for aligning trial pipeline to trial needs profilesMAPPING OPPORTUNITIES ACCORDING TO COUNTRY ATTRIBUTESTrial segments map to four trial types based on country capability needs to execute those trialsTrial Intensity(visit burden and medical complexity)Patient volume(number of patients)PIoncologyCAGT

240、BiosimilarsPII/IIIprimaryRarediseasePII/IIIoncologyPII/IIIbiologicsPII/IIIIDVPhase ISize=number of 2023 trial startsCapability requirementPipeline mapping:Trial demandsScientificemphasisClinicalfocusMedicalmaturityClinicalefficiencyCountry capability mappingTrial type&country capabilitiesClinical fo

241、cusClinicalefficiency ScientificemphasisMedical maturityPatient availability(patient volume in reach of basic healthcare infrastructure e.g.,healthcare access,primary physicians)*Operational infrastructure (access to water,internet,doing business,safety and sound government)Clinical infrastructure(e

242、stablished clinical sites,data standardization,regulatory support)*/*Medical infrastructure(healthcare system quality,established specialty sites,innovation)Specific capability requirement /*Notes:Patient Volume is an index based on average number of patients/trial for each trial segment across the

243、decade while Trial intensity is an index based on an average of number of enrollment criteria and endpoints per trial and expert estimation of medical complexity of patients for all trials run in each trial segment from 2013 to 2022.Every trial is unique in its characteristics and site needs;however

244、,it is useful to look in aggregate at the trial segments previously identified and match these to country capabilities grouped into general trial types.Trial segments align to four basic trial types when characterized by trial intensity and patient volume requirements,and mapping against the require

245、d country capabilities creates unique profiles for each.The Clinical Focus trial type accounts for 17%of the 2023 pipeline and includes all non-oncology Phase I trials,which have a moderate number of patients and a low trial intensity requiring moderate,although unique,clinical infrastructure.Clinic

246、al Efficiency trials make up 21%of the 2023 pipeline and groups Phase II and III primary care,infectious disease and all biosimilars based on their common need for higher patient numbers,but relatively low trial intensity.The Scientific Emphasis trial type includes 34%of 2023 trials and is defined a

247、s trials requiring low patient volume but high trial intensity,and includes rare disease,cell and gene therapy,and Phase I oncology all of which are expected to need countries with robust infrastructure across all dimensions but not necessarily high patient numbers.Medical Maturity makes up 28%of th

248、e trial pipeline and includes Phase II/III oncology and biologics based on high patient numbers and high trial intensity,and these trials are expected to require countries with high patient availability and operating infrastructure.Source:Citeline Trialtrove,Jan 2024;IQVIA Institute,June 2024.iqviai

249、nstitute.org|29 The 10 most-and least-used countries in this analysis have significantly different footprints when mapped against the algorithm metrics,while trial types have more subtle differences.All metrics except affordability,patient need,and trial competition score higher for the 10 most-used

250、 than the 10 least-used with differences in magnitude of difference pointing to some country attributes being more important to country selection and trial success.Fixed broadband-which is directly relevant to assessing site readiness for clinical data capture and transmission and a proxy for inform

251、ation technology use more generally-and sound governance metrics vary most widely when comparing operational infrastructure attributes for the 10 most-and least-used countries.Clinical site density a measure of clinical trial experience and capacity,affordability and regulatory quality vary the most

252、 across 10 most-and least-used trials and across trial types.Notably,the affordability metrics are highest for clinical effectiveness trials in the 10 least-used countries and lowest in the medical maturity trials in the 10 most-used countries likely because highly affordable countries have lagging

253、infrastructure,which may be more critical to medical maturity trial execution than affordability.Comparison of patient availability metrics across most-and least-used countries highlights the Healthcare Access and Quality Index which speaks to patient access to basic healthcare facilities and the nu

254、mber of physicians as having the largest difference.Exhibit 21:Average metric scores for 10 most-and least-used countries by trial typeNotes:Only countries with 5 or more trials per year on average 20212023 and above the 15th percentile for safety and stability metric,governance metric,population an

255、d number of physicians were included in the analysis;All metrics and scores have been scaled to 100;10-most and 10-least used countries designations are based on 20212023 average trials/country sites analyzed for site number and site density were active Phase I sites for Clinical Focus,all active si

256、tes for Clinical Efficacy and all active specialist sites for Scientific Emphasis and Medical Maturity.See Methodologies for source detail and additional notes.MAPPING OPPORTUNITIES ACCORDING TO COUNTRY ATTRIBUTESAttributes of the 10 most-and least-used countries are significantly different with mor

257、e subtle differences between trial typesSource:Citeline Trialtrove,Jan 2024;Citeline Sitetrove,March 2024;World Health Statistics4,March 2024;World Bank,Development Indicators DataBank5,March 2024;World Bank,Doing Business DataBank6,March 2024;World Bank,Worldwide Governance Indicators7,March 2024;P

258、hRMA,Global Access to New Medicines Report,April 20238;ILO Stat explorer9,March 2024;Moore et.al.,JAMA International Medicine,Nov 201810;Healthcare Access and Quality Index 19902019.Institute for Health Metrics and Evaluation(IHME),202211;IQVIA Institute,June 2024.Patient availabilityClinical infras

259、tructureOperational infrastuctureClinical efficiency 10 most-usedClinical focus 10 most-usedMedical maturity 10 most usedScientific emphasis 10 most-usedClinical efficiency 10 least-usedClinical focus 10 least-used Medical maturity 10 least-usedScientific emphasis 10 least-usedFixed broadband subscr

260、iptionsSound governanceAffordability(wages)Competition(inverse trial density)Number of physiciansRegulatory qualityRegulatory start-up efficiencyPopulationPatient need(inversedrug reimbursement)Affordability(trial costs)Health access andquality index(IHME)Healthy life expectancy at birthAccess to wa

261、terPaying taxesStability and safetyNew drug approvals2022 clinical site densityTrading across boaders100908070605040302010030|Rethinking Clinical Trial Country Prioritization:Enabling Agility through Global Diversification Ranking of country readiness for each of the specific trial types based on th

262、e refined metric inclusion and weighting to reflect country needs by trial type (Figure 4 in Methodologies)differs from country rankings based on the aggregate of all trials and reveals some important differences in country readiness between trial types.Each trial type still prioritizes U.S.,Western

263、 European countries,Japan,China,and South Korea in the top 10 with minor differences in ranking order.Clinical focus and scientific emphasis include Australia in the top 10 countries,while clinical efficiency and medical maturity include Poland,reflecting more patient availability in this Central Eu

264、ropean country.Looking beyond the top 10 countries,the trial type lists show more significant differences from each other,with each including more APAC,Latin and Central American,and Eastern European countries.India is a good example of a country that is prioritized significantly differently based o

265、n trial type,ranking as the 13th country for clinical focus and clinical efficiency and 14th for medical maturity all trials with higher patient needs while ranking at number 25 for scientific emphasis where infrastructure needs outweigh patient requirements.Chile,Portugal,Malaysia,Greece,and Switze

266、rland are examples of countries that were not in the current 25-most-used countries but were prioritized by the Country Readiness algorithm as one of the top 25 countries for at least two of the trial types.Exhibit 22:Top 25 countries by Readiness Score ranking by trial typeNotes:Only countries with

267、 5 or more trials per year on average 20212023 and above the 15th percentile for safety and stability metric,governance metric,population and number of physicians were included in the analysis;All metrics and scores have been scaled to 100.;sites analyzed for site number and site density were active

268、 Phase I sites for Clinical Focus,all active sites for Clinical Efficacy and all active specialist sites for Scientific Emphasis and Medical Maturity.See Methodologies for source detail and additional notes.MAPPING OPPORTUNITIES ACCORDING TO COUNTRY ATTRIBUTESPrioritization based on infrastructure a

269、nd patient volume points to slightly varied country readiness across trial types Not a current 10 most-used countryNot a current 25 most-used countryUnited StatesGermanyJapanChinaFranceSpainUnited KingdomItalySouth KoreaAustraliaCanadaPolandIndiaBrazilNetherlandsSwedenBelgiumPortugalGreeceChileMexic

270、oMalaysiaArgentinaRomaniaSwitzerlandUnited StatesJapanGermanyFranceChinaSpainUnited KingdomItalySouth KoreaPolandAustraliaCanadaIndiaBrazilChilePortugalMalaysiaNetherlandsGreeceRomaniaSwedenArgentinaSwitzerlandIndonesiaMexicoUnited StatesJapanGermanySpainFranceChinaItalyUnited KingdomAustraliaSouth

271、KoreaCanadaPolandNetherlandsSwedenPortugalBelgiumBrazilGreeceSwitzerlandCzech RepublicArgentinaHungaryChileAustriaIndiaUnited StatesJapanGermanyChinaFranceSpainItalyUnited KingdomSouth KoreaPolandAustraliaCanadaBrazilIndiaNetherlandsSwedenArgentinaPortugalChileMexicoGreeceBelgiumMalaysiaRomaniaColom

272、biaClinical focusClinical efficiencyScientific emphasisMedical maturitySource:Citeline Trialtrove,Jan 2024;Citeline Sitetrove,March 2024;World Health Statistics4,March 2024;World Bank,Development Indicators DataBank5,March 2024;World Bank,Doing Business DataBank6,March 2024;World Bank,Worldwide Gove

273、rnance Indicators7,March 2024;PhRMA,Global Access to New Medicines Report,April 20238;ILO Stat explorer9,March 2024;Moore et.al.,JAMA International Medicine,Nov 201810;Healthcare Access and Quality Index 19902019.Institute for Health Metrics and Evaluation(IHME),202211;IQVIA Institute,June 2024.iqvi

274、ainstitute.org|31Exhibit 23:Country opportunity by trial type Top 25 countries by Readiness Score MAPPING OPPORTUNITIES ACCORDING TO COUNTRY ATTRIBUTESCountry opportunities differ across trial types although Japan,Germany and France have larger opportunities across all typesFranceSpainJapanItalyGerm

275、anyPolandBrazilSwedenPortugalGreeceArgentinaMalaysiaChileCanadaUnited KingdomSwitzerlandRomaniaMexicoNetherlandsBelgiumIndiaAustraliaSouth KoreaUnited StatesChinaClinical focusClinical efficiencyScientific emphasisMedical maturity-100-50050JapanGermanyFranceChileItalyPortugalSouth KoreaMalaysiaIndon

276、esiaGreeceSwitzerlandRomaniaSwedenUnited KingdomBrazilSpainNetherlandsAustraliaArgentinaMexicoPolandIndiaCanadaChinaUnited States-100-50050JapanGermanyFranceSpainItalySwedenPortugalSouth KoreaChileBrazilPolandGreeceSwitzerlandArgentinaIndiaAustriaCzech RepublicHungaryUnited KingdomNetherlandsBelgium

277、CanadaAustraliaUnited StatesChins-100-500 50JapanGermanyFranceUnited KingdomBrazilIndiaItalySpainColumbiaSwedenPortugalChileMalaysiaPolandArgentinaRomaniaMexicoSouth KoreaUnited StatesGreeceNetherlandsAustraliaCanadaBelgiumChina-100-50050100100100100197138124271-298-402-127-290-143-209-364205Notes:O

278、nly countries with 5 or more trials per year on average 20212023 and above the 15th percentile for safety and stability metric,governance metric,population and number of physicians were included in the analysis;All metrics and scores have been scaled to 100.;sites analyzed for site number and site d

279、ensity were active Phase I sites for Clinical Focus,all active sites for Clinical Efficacy and all active specialist sites for Scientific Emphasis and Medical Maturity.Country Opportunity is the difference between the Readiness Score and the Actual Trials Score for each country.See Methodologies for

280、 source detail and additional notes.Prioritization of countries using trial type specific analysis and comparing to current utilization patterns based on clinical trial starts in the period 202123 identifies opportunities for greater utilization as well as countries where current demand may be stret

281、ching capacity and resources in ways that negatively impact enrollment times.The clinical focus opportunity analysis prioritizes France,Spain,and Japan as the three countries with the most potential for more studies based on Country Readiness scoring.Japan is highlighted across clinical efficiency,s

282、cientific emphasis and medical maturity as having the highest opportunity,because despite having strong infrastructure and patient availability,Japan is limited in actual use on global trials because of its concentrated ethnicity and requirements for Phase I testing to be done in country before any

283、later stage global trials use Japanese sites.Germany and France have the next highest differences between the Country Readiness scores and the actual number of trials being run for clinical efficiency,scientific emphasis and medical maturity,which in part reflects the drop in relative European count

284、ry utilization over the past five years.Given that Country Readiness trial allocation is based on reallocation of current trial volume based on Clinical Readiness Scores,the assumption is that trial capacity is constant across the pipeline meaning that any indication of an opportunity based on under

285、-utilization of one country is offset by a prediction of an overutilization in another.As such,the United States and China are both indicated as over-utilized for clinical focus,clinical efficiency and scientific emphasis trials,while Belgium and China are over utilized for trials requiring medical

286、maturity.Source:Citeline Trialtrove,Jan 2024;Citeline Sitetrove,March 2024;World Health Statistics4,March 2024;World Bank,Development Indicators DataBank5,March 2024;World Bank,Doing Business DataBank6,March 2024;World Bank,Worldwide Governance Indicators7,March 2024;PhRMA,Global Access to New Medic

287、ines Report,April 20238;ILO Stat explorer9,March 2024;Moore et.al.,JAMA International Medicine,Nov 201810;Healthcare Access and Quality Index 19902019.Institute for Health Metrics and Evaluation(IHME),202211;IQVIA Institute,June 2024.32|Rethinking Clinical Trial Country Prioritization:Enabling Agili

288、ty through Global DiversificationExhibit 24:Comparison of metrics for select countries versus average of metrics for top 10 most-used countries 20212023 MAPPING OPPORTUNITIES ACCORDING TO COUNTRY ATTRIBUTESComparing specific metrics relative to the most-used countries reveals the drivers of opportun

289、ity scores for individual countriesNotes:Only countries with five or more trials per year on average 20212023 and above the 15th percentile for safety and stability metric,governance metric,population and number of physicians were included in the analysis;10-most and 10-least used countries designat

290、ions are based on 20212023 average trials/country.All metrics and scores have been scaled to 100.Top 3 countries based on Opportunity Scores across trial types were selected.Comparison of individual metrics for Japan,Germany,and France to metrics for the top 10 most-used countries highlights differe

291、nces that can explain utilization and score differences and provide guidance for investment opportunities.Japan out-performs the current most used countries on most metrics except patient need,start-up efficiency,trading-across borders,and fixed broadband,although lack of patient diversity and speci

292、fic regulatory requirements are likely playing a role in underutilization not captured by this analysis.Easing of Phase I requirements for global clinical trials in Japan and ongoing regulatory process streamlining may give reason to consider inclusion of Japan in global clinical trials,although lac

293、k of population diversity will remain a factor.While Germany metrics are showing positive regulatory quality and start-up efficiency scores,it is possible that actual trial utilization,which has seen a significant drop in the last five years,reflects recent challenges to EU Clinical Trial Regulation

294、(CTR)implementation1 efforts and complex data privacy rules,is due for a rebound as CTR implementation eases,creating a forward-looking opportunity.Finally,France shows significant opportunity based on scores versus actual current utilization and French metrics slightly lag top 10 most utilized coun

295、tries for patient need,number of physicians,population,affordability,and safety and stability raising some areas for potential focus in seizing on opportunity around other attributes that score well.Competition(inverse trial density)Patient need(inverse drug.Number of physiciansHealthcare access and

296、 qualityPopulationRegulatory start-up efficiencyRegulartory qualityAffordability(trial costs)Affordability(wages)Active site densityHealthy life expectancy at birthNew drug approvalsSound governanceStability and safetyTrading across bordersPaying taxesFixed broadband subscriptionsAccess to waterJapa

297、n difference to 10 most-used(all trials)-20-10010203040-20-10-15-505101520-100-5105152025Germany difference to 10 most-used(all trials)PatientavailabilityClinicalinfrastructureOperationalinfrastructureFrance difference to 10 most-used(all trials)Source:Citeline Trialtrove,Jan 2024;Citeline Sitetrove

298、,March 2024;World Health Statistics4,March 2024;World Bank,Development Indicators DataBank5,March 2024;World Bank,Doing Business DataBank6,March 2024;World Bank,Worldwide Governance Indicators7,March 2024;PhRMA,Global Access to New Medicines Report,April 20238;ILO Stat explorer9,March 2024;Moore et.

299、al.,JAMA International Medicine,Nov 201810;Healthcare Access and Quality Index 19902019.Institute for Health Metrics and Evaluation(IHME),202211;IQVIA Institute,June 2024.iqviainstitute.org|33 Clinical trial country utilization analysis indicates a recent significant shift in which countries-and how

300、 many-are being used and country characterization suggests that there are opportunities to continue to shift the country mix in industry trials.Framing of these opportunities will be critical for near term decision-making and for longer-term investments for sponsors,for industry associations and for

301、 governments and public-private entities working to improve country access to clinical trials and to medicines.In the immediate horizon,having access to data including baseline metrics,site and country operational performance data,patient data and advanced analytics to dynamically prioritize countri

302、es for near term trials will be critical for sponsors and CROs.Governments and in-country economic development entities will need to harness similar analytics to characterize country capabilities and align them to the industry pipeline to identify immediate trial and partner opportunities.Longer ter

303、m,sponsors and CROs need to consider evolving clinical trial pipeline needs by trial segment and identify countries with the most potential and make strategic investments to ensure access and capacity in optimized country ecosystems.Similarly,in-country stakeholders will need to analyze pipeline evo

304、lution and ensure that clinical research capabilities are aligned to strengths,but also to the evolving needs of the industry,including addressing infrastructure,and operating processes that industry cannot strengthen by itself.Source:IQVIA Institute,June 2024.Exhibit 25:Country prioritization horiz

305、onsMAPPING OPPORTUNITIES ACCORDING TO COUNTRY ATTRIBUTESSponsors and countries have opportunities to extend portfolio readiness with strategic focus on country attributesTrialists:Sponsorsand CROsCountries:Economic developers and industry associations Identify country needs for portfolio(trial segme

306、nt and trial type breakdown)Analyze country attributes(metrics and scores)for trial types of importance Consider near term specific focus and constraints(patient volume and competition,epidemiology and standard of care)Prioritize near term country utilization based on countries that align best to im

307、mediate portfolio needs Characterize mid-and long-term pipeline focus and clinical trial requirements Identify under-utilized countries with addressable gaps that align to mid-term pipeline needs Make targeted gap-fill investments to support mid-and long-term portfolio(e.g.,site support/training to

308、improve clinical metrics for countries with high patient capacity but clinical gaps)Review trial capacity and readiness metrics and consider strengths and weaknesses Review industry clinical pipeline and align strengths to trial types and segments(e.g.,large patient and physician population critical

309、 for enrolling large IDV trials)Leverage partnerships to develop selected country trial readiness/-capabilities Analyze industry pipeline growth and relative alignment to country strengths and gaps and develop strategy to improve/bolster areas of opportunity Identify specific attributes/metrics with

310、 gaps to other countries and invest to improve Establish partnerships around investment and improvements Immediate horizon Aligning current country capabilities Focus on countries with current readiness that are being under-utilized/overlookedInvestment horizon Strategic country capability developme

311、nt Focus on countries with high patient availability but clinical or operational gaps34|Rethinking Clinical Trial Country Prioritization:Enabling Agility through Global Diversification Looking beyond the countries with highest current readiness allows for focus on opportunity tier options where coun

312、tries have good patient availability potential but lag other countries in operational infrastructure.India,Brazil and South Africa are examples of countries with unique patient availability potential,especially in patient intensive trial types including clinical efficiency and medical maturity.India

313、 presents a significant patient access and affordability opportunity but lags highly utilized countries across most country infrastructure and clinical infrastructure metrics.Recent regulatory improvements and public-private investments in diabetes and oncology clinical research infrastructure espec

314、ially in urban settings supports a shift in India readiness.Brazil also has a significant patient access opportunity and recent legislation focused on regulatory process improvements and multiple public-private investments in clinical research capacity building have been important changes that may a

315、ddress infrastructure gaps.South Africa has the potential to enable access for unique pools of patients to participate in clinical trials and,like Brazil and India has seen significant recent government focus as part of pan-Africa efforts targeting regulatory process harmonization and public private

316、 investment in clinical research capacity building.Using case studies to highlight longer term country opportunitiesTaken together,opportunity tier efforts highlight the complexity of enabling clinical research in new geographies,but also the importance of leveraging novel capacity building mechanis

317、ms to leapfrog existing processes to deliver desired changes in the clinical research landscape.iqviainstitute.org|35 Plotting Operational Readiness and Patient Availability Scores yields an array which provides further insight into Country Readiness Scores and allows for focus on next tier and oppo

318、rtunity tier options.In this analysis,the next tier includes many of the smaller Western European countries including Demark,Ireland,and Belgium as well as Central and Eastern European countries including Bulgaria,Romania,and Poland.Next tier countries are not being highlighted as the top countries

319、in the Readiness Scores,or as having extra capacity with the Opportunity Score because they have lower patient availability scores and may have capacity or trial saturation concerns.Sponsor,CRO-partner and public-partner specific efforts and investment to build site and patient capacity including si

320、te partnerships and AI and data enabled patient identification are strategies that can overcome potential over-saturation risks.Conversely,the opportunity tier highlights countries with a lot of patient availability,but lower operational readiness,and Latin America,Asia Pacific and African countries

321、 are heavily represented here.These countries present an enormous opportunity to access patients and markets for industry-sponsored clinical trials and calls for global capacity development point to the importance of looking beyond currently utilized countries to enable more equitable and more effic

322、ient clinical trials.12Exhibit 26:Operational Readiness and Patient Availability Scores for all countries considered in analysisNotes:Only countries with five or more trials per year on average 20212023 and above the 15th percentile for safety and stability metric,governance metric,population and nu

323、mber of physicians were included in the analysis;All metrics and scores have been scaled to 100.Operational Readiness Score combines Operational Infrastructure and Clinical Infrastructure scores See Methodologies for source detail and additional notes.USING CASE STUDIES TO HIGHLIGHT LONGER TERM COUN

324、TRY OPPORTUNITIESAnalyzing countries by patient availability and operational readiness highlights next tier opportunitiesSource:Citeline Trialtrove,Jan 2024;Citeline Sitetrove,March 2024;World Health Statistics4,March 2024;World Bank,Development Indicators DataBank5,March 2024;World Bank,Doing Busin

325、ess DataBank6,March 2024;World Bank,Worldwide Governance Indicators7,March 2024;PhRMA,Global Access to New Medicines Report,April 20238;ILO Stat explorer9,March 2024;Moore et.al.,JAMA International Medicine,Nov 201810;Healthcare Access and Quality Index 19902019.Institute for Health Metrics and Eval

326、uation(IHME),202211;IQVIA Institute,June 2024.10090807060504030201000102030405060708090100Operational Readiness ScorePatient Availability ScoreArgentinaAustraliaAustriaBelgiumBrazilBulgariaCanadaChileChinaColombiaCosta RicaCzech RepublicDenmarkDominican RepublicFinlandFranceGermanyGreeceGuatemalaHun

327、garyIndiaIndonesiaIrelandItalyJapanJordanMalaysiaMexicoNetherlandsNew ZealandNorwayPeruPolandPortugalRomaniaSerbiaSingaporeSlovakiaSouth AfricaSouth KoreaSpainSwedenThailandUnited Arab EmiratesUnited KingdomUnited StatesVietnamOpportunity tierCurrent top tierNext tier36|Rethinking Clinical Trial Cou

328、ntry Prioritization:Enabling Agility through Global DiversificationExhibit 27:Approach to tier specific horizon planningUSING CASE STUDIES TO HIGHLIGHT LONGER TERM COUNTRY OPPORTUNITIESTrial sponsors and countries can formulate near-and long-term strategies around country tiers Strategic country sel

329、ection horizon planning can be approached with more specificity across these tiers.Top tier countries provide the most immediate opportunity for sponsors and CROs.In these countries,it will be important for sponsors and CROs to use broadly available metrics as well as internal and partner based oper

330、ational data to optimize country alignment to specific trial needs.Longer term,maintaining top tier country opportunity will require ongoing investment in capacity building and support to and for infrastructure upgrades around policy and technology to maintain operational quality.Next tier countries

331、 with high operational quality but lower patient availability present an opportunity for sponsors and CRO partners that have site networks or partnerships that enable additional capacity,and whose analytics enable identification of specific pockets of patient capacity for clinical trial placement.Th

332、e opportunity tier has significant patient availability,but limited clinical and operational infrastructure,and in the near term offers significant opportunity in patient intensive trials to experienced sponsors and CROs that can support site and country infrastructure with strategies like site staf

333、f support,mobile infrastructure and decentralized trial technology and capabilities.An important caveat to this is countries with safety,governance or policy challenges that create risks and unpredictability that cannot be overcome in the near term with operational experience or investment.Longer term investments in the opportunity tier include targeted site and infrastructure investments by spons

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