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Institute Report
Rethinking Clinical Trial Country Prioritization
Enabling agility through global diversification
Jul 10, 2024
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The biopharma clinical research ecosystem has been undergoing a significant evolution in the last five years as technological, 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 concerns, 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 characterize 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 single country trials.

Key findings:

  • Clinical trial enrollment duration has been increasing over the past five years, and the time from trial start to the end of enrollment has increased by 26% across all phases.
  • Over the same period, clinical trial country utilization has been declining while key drivers of clinical trial complexity have been increasing.
  • Combined with serial geopolitical, health and environmental disruption and uncertainty in the clinical trial operating ecosystem, this suggests an opportunity to diversify country utilization to mitigate timeline and disruption risks.
  • Country utilization by region has shifted significantly in the past five years with Western Europe share declining by 21% (from 32% to 25% of global total) and Eastern Europe share decreasing 33% (from 17% to 11%), as North America share increased 17% (from 19% to 23%) and China share increased 57% (from 10% to 15%).
  • Analysis of country attributes has enabled an industry- and stakeholder-wide view of readiness for clinical trials in the form of a Clinical Trial Readiness Score that allows for ranking of countries by trial type and examination of specific investment and improvement opportunities to increase use of potentially underutilized countries.

Other findings:

Enrollment is taking longer across all phases of development
  • 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 all 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 months over the five-year timeframe.

Country utilization has decreased significantly in Europe since 2019, while China and North America use has increased
  • The global share of total country-uses per region for trials started 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 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%.

Country utilization is heavily consolidated in U.S., China and Western European countries
  • 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 used 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 2021–2023 timeframe.
  • The next 10 countries are 19% of the country-use share, the next 30 are 20%, and the next 95 countries account for only 3% of the total country uses in 2021–2023.

Transparent Country Readiness analysis helps answer questions arising from a dynamic clinical trial operating environment
  • 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 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 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.

Analyzing countries by patient availability and operational readiness highlights next tier opportunities
  • 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 ‘opportunity 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 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.

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