Considerations For Embedding Inclusive Research Principles In The Design And Execution Of Clinical Trials

By Ubong Peters MASc, PhD, Brenna Turner, Daniel Alvarez MD, Makaelah Murray, Aruna Sharma RN, M.HSc, Shalini Mohan MD, and Shilpen Patel MD, FACRO, FASTRO

There is a growing recognition that the clinical research sector faces a diversity challenge. This challenge stems from the fact that many clinical trials fail to enroll individuals from historically marginalized groups or those who accurately represent real-world data. This underrepresentation occurs at a rate far below the actual occurrence and prevalence of the disease or condition being targeted by the investigational therapy or device. This lack of diversity in clinical research participation has the potential to cloud our understanding of the safety and effectiveness of medical treatments. It also restricts our collective capacity to develop therapies that work effectively for all patients, ultimately exacerbating existing health disparities.

This review article offers a comprehensive examination of the impact of this bias on public health. It delves into the various barriers that historically marginalized populations encounter when attempting to participate in clinical research. Additionally, it explores practical solutions aimed at increasing diversity in clinical trial enrollment. These solutions include a pivotal role to be played by clinical trial sponsors, research organizations, patients, and caregivers in supporting the industry's efforts to achieve this ambitious yet essential objective.