2024重新思考临床试验国家优先顺序-通过全球多元化实现敏捷性报告

Rethinking Clinical Trial Country Prioritization: Enabling Agility through Global Diversification

Overview

The biopharmaceutical clinical research ecosystem has undergone significant changes over the past five years due to technological, environmental, societal, regulatory, and geopolitical shifts. These changes have resulted in slower clinical development timelines, impacting patient treatment options and outcomes. As a result, clinical trial country prioritization has become a critical focus for stakeholders.

The Need for Clinical Trial Global Diversification

• Increased Enrollment Times: Across all phases and therapeutic areas, average enrollment times have increased by 26% from 2019 to 2023. Specifically:

  • Phase I: Increased by 39%, taking five months longer in 2023 compared to 2019.
  • Phase II: Increased by 29%, adding six months.
  • Phase III: Increased by 16%, taking three months longer.
  • Oncology, neurology, and cardiovascular showed the greatest increases, ranging from five to six months.

• Decreased Country and Site Utilization: The average number of countries and sites per trial decreased by 20% and 15%, respectively. This trend has been most pronounced in oncology and neurology trials.

• Emerging Biopharma Companies (EBPs): EBPs are sponsoring a record high share of trials but are using fewer countries and are more likely to run single-country trials. They have seen a sharper decline in the number of countries per trial compared to large pharmaceutical companies (15% vs. 10%).

• Geopolitical Volatility: Recent geopolitical events, viral outbreaks, and the transition to a multipolar world have contributed to disruptions in global trial enrollment and execution, highlighting the need for site and country diversification.

Assessing Country Attractiveness Based on Trial Types

• Trial Characteristics: Patient volume, medical complexity, and visit intensity are used to define trial segments more distinctly than traditional therapeutic area segmentation. A set of nine categories is suggested, blending phase, therapeutic, mechanistic, and regulatory differences in clinical trial execution.

• Enrollment Duration and Number of Countries: Each segment is distinct against complexity and volume metrics, providing insights into drivers of enrollment duration and country usage.

Recent Trends in Reallocating Trial Sites Across Regions and Countries

• Regional Shifts: There has been a significant rebalancing of global clinical trial activity, moving away from Europe towards China and North America.

  • Western Europe remains the most utilized region, but its relative share of country-uses has dropped by 21% from 2019 to 2023.
  • China's utilization is primarily driven by China-headquartered companies running single-country trials, particularly in Phase I, oncology, and cell and gene therapy.
  • The 10 leading countries account for 58% of total clinical trial country-uses from 2021 to 2023, while the next 10 account for only 19%.

• Concentration of Trial Activity: The concentration of trial activity by country has increased over the past five years, with the top 10 countries accounting for 58% of total clinical trial country-uses, while the next 40 account for 16% and the remaining 95 countries account for 26%.

Mapping Opportunities According to Country Attributes

• Prioritization Process: A systematic process to evaluate countries' reliability for recruiting and executing clinical trials is essential given the evolving landscape of clinical trial capabilities and capacity.
• Characteristics of Successful Countries: The prioritization process should address questions about the characteristics of a successful country, relative clinical trial opportunities, and infrastructure readiness.

This analysis aims to provide a basis for longer-term industry-wide decision-making, expanding the pool of countries suitable for clinical trials.