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.
WEBINAR OUTLINE
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 In April 2022, FDA issued new draft guidance on Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials that OCE Project Equity led.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.
WEBINAR OUTPUT
Marie von Lilienfeld-Toal
Prof. Marie von Lilienfeld-Toal is professor of Medicine at the University Clinic of Jena in Germany. Her clinical and scientific focus on haematological malignancies and Infectious Diseases in immunocompromised patients with a focus on virology. She is also the author of the “COVID-19 Guidelines of the German, Austrian and Swiss Societies of Haematology-Oncology” and “EHA SWG Infections in Hematology FAQ Recommendations.”
Lola A. Fashoyin-Aje
Lola A. Fashoyin-Aje, MD, MPH, is a medical oncologist and Deputy Director in the Division of Oncology 3 (DO3) in the Office of Oncologic Diseases (OOD) at the Center for Drug Evaluation and Research- Food and Drug Administration (FDA). In this role, she provides scientific and policy guidance and oversight to multidisciplinary teams reviewing drugs and biologics under development for the treatment of solid tumor malignancies (gastrointestinal, cutaneous, and sarcoma). Dr. Fashoyin-Aje is also Associate Director of Scientific and Policy initiatives to address disparities in drug development in the FDA Oncology Center of Excellence (OCE). In this role, she provides direction and oversight on all scientific and policy efforts related to improving the inclusion of participants who are members of historically underrepresented demographic groups, in oncology medical product development programs. Prior to joining the FDA, Dr. Fashoyin-Aje completed her undergraduate and graduate training at Columbia University and Yale University, respectively, and received her M.D. degree from the University of Rochester School of Medicine and Dentistry. She completed her training in internal medicine and medical oncology at Johns Hopkins.