The Cancer Drug Development Forum organized a live webinar on the topic of Diversity in Clinical Trials on Monday 26 September 2022 at 17:00 (CEST). This webinar was composed of a 15-minute lecture given by Prof. Dr. Marie von Lilienfeld-Toal (University of Jena, DE) & 15-mini lecture given by Dr. Lola Fashoyin-Aje (FDA, US) followed by a 30-minute discussion session.
Increasing clinical trial diversity in cancer trials is both a societal and scientific obligation. Underrepresentation of data from a diverse group of individuals is a barrier to understanding the safety, efficacy, and effectiveness of novel therapy in real-world populations impacted by the disease. To ensure scientific advances are beneficial and equitable to all relevant patient populations, we must consider inclusive trial designs with appropriate representation of vulnerable and disadvantaged populations. According to a recent study, minority racial and ethnic groups comprise nearly 40% of the population in the US; however, 75% of the 32,000 participants in the trials of 53 novel drugs approved in 2020 by the FDA were White.
While challenges with inequalities in patient representation in clinical trials might be different in the EU, it is nonetheless an important barrier to cancer care access. The goal of this webinar was to create awareness of why and how a lack of diversity in cancer clinical trials can ultimately hurt advancing knowledge in cancer care and patient access to innovations. In April 2022, FDA issued new draft guidance on Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials that OCE Project Equity led. Our distinguished speakers discussed missed opportunities when clinical trials are not representative of the real-world population and also missed opportunities for improving patient outcomes.