Diversity At The Start: Best Practices For Clinical Trial Planning

Claire Riches, Citeline's VP of Clinical Solutions, emphasizes that clinical trial diversity must start with a fit-for-purpose protocol, incorporating the patient voice early on to ensure success in reaching diverse populations. In a Citeline webinar, industry leaders shared best practices, including GSK's focus on embedding population-related scientific questions into protocols, ensuring data consistency, and harmonizing demographic data across sources.

Pfizer is similarly committed to achieving census or disease epidemiology levels of participation in its trials. Leo Russo, Pfizer's VP and Head of Global Medical Epidemiology, outlined the company’s approach of adjusting for factors like disease severity in underrepresented populations, such as African Americans in bladder cancer studies.

AbbVie is evolving its protocols and policies to ensure broad eligibility criteria and inclusive designs. Natalie Monegro, AbbVie's VP of Global Medical Epidemiology, highlighted the company's methodology for benchmarking trials and integrating patient voices at every stage, from pretrial to post-trial.

Bristol Myers Squibb (BMS) is taking further steps to improve diversity, running the Robert A. Winn Diversity in Clinical Trials Award program to develop racially and ethnically diverse clinical investigators. BMS also examines how eligibility criteria might inadvertently exclude certain populations.

GSK’s efforts include running targeted studies, such as EBONI, which focuses on barriers to PrEP treatment in Black cisgender and transgender women. Pfizer, meanwhile, is working on defining diversity for global trials, recognizing that FDA guidelines leave room for interpretation regarding non-U.S. populations.

The industry recognizes that improving diversity is an ongoing process. As Lorena Kuri from BMS pointed out, the challenge lies in "unlearning and relearning" established practices to better serve diverse patient populations. While progress is being made, the industry continues to evolve its approach as FDA diversity plan guidance undergoes further review and development.