Assessing The Current Regulatory Landscape of Representation Within Clinical Trials for The Major Regulatory Regions:...

Health inequity persists globally, highlighting the ethical need for organizations that manage clinical trials to ensure the representation of the target population is reached. There is increasing recognition by many regulatory bodies of the importance of promoting representation and inclusion in clinical trials. However, guidelines vary substantially between countries, likely due to historical, cultural, and social differences that may impact how representation is defined. This review summarizes and compares current guidance in the major regulatory regions to understand how future guidance on representation and inclusion in clinical trials can be developed and successfully implemented across different regions with varying representation needs.

Published guidelines/regulations related to representation in clinical trials were obtained from a search of public health authority and government websites.

Guidelines in the US, Canada, EU, and UK provide specific guidance on representation in clinical trials. In contrast, guidance in Australia, Brazil, China, India, Japan, and South Africa typically involves generalized recommendations that address some aspects of representation and inclusion.

Regulatory guidance on representation and inclusion promotes consideration of patient characteristics beyond race and ethnicity, now including geographic location, age, comorbidities, and socioeconomic status. However, countries may interpret representation differently, leading to overly prescriptive regulations that could inhibit implementation of global clinical trials. Thus, compromise should be sought when developing regulations to allow for investigation and development of treatments across diverse populations without restricting or delaying approval of and access to those treatments.