On February 15th, Friends of Cancer Research (Friends) hosted a virtual public meeting, “Enhancing Diversity in Clinical Trials: Implementation of Diversity Plans,” emphasizing the importance of ensuring diverse representation in clinical trials to promote health equity, minimize biases, and foster holistic approaches in scientific research. Prior to the meeting, a discussion document, “Improving Equity in Oncology Clinical Trials: Challenges and Strategies for Setting Diversity Enrollment Goals” was made publicly available. The discussion underscored that achieving more inclusive and representative patient populations in clinical trials requires a multifaceted approach involving robust data analysis, strategic planning, community engagement, and inclusive trial practices.
Morning Keynote Featuring Rep. Anna Eshoo (D-CA) and Dr. Namandjé Bumpus, Principal Deputy Commissioner, FDA
The meeting opened with a keynote speech from Rep. Anna Eshoo (D-CA), who discussed the importance of enhancing diversity in clinical trials and her role in passing the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act. The legislation, which Friends worked closely with Rep. Eshoo and committee staff to support, became law as part of the 2023 Omnibus package and, requires companies to report to the U.S. Food and Drug Administration (FDA) their plans to include diverse patient groups in clinical trials. Prior to the DEPICT Act, the FDA’s efforts to improve clinical trial diversity were voluntary. Rep. Eshoo underscored the importance of the legislation to ensure that all Americans have confidence that treatments being developed will work for them, regardless of their ethnicity or age.
Dr. Namandjé Bumpus, FDA’s Principal Deputy Commissioner and the second keynote speaker, highlighted the agency’s dedication to enhancing diversity in clinical trials. She emphasized this commitment by referring to the FDA guidance and policies, which encompasses considerations of age, sex, race, ethnicity, and other factors such as comorbidities. She outlined the need to improve generalizability of study results in addition to strategies to overcome barriers to enrollment for underrepresented groups. These strategies include community engagement and support, leveraging digital health technologies, and decentralizing trial elements.
Session 1: Data-Driven Approaches for Establishing Diversity Enrollment Targets
(Click here to watch Session 1 discussions)
Riha Vaidya of Fred Hutchinson Cancer Center moderated the discussion for Session 1. Panelists Xoli Belgrave, Parexel, Henry Bennett, Novartis, ‘Lola Fashoyin-Aje, U.S. FDA, Anne-Michelle Noone, National Cancer Institute (NCI), and Cleo A. Ryals, Flatiron Health explored data sources for setting diversity enrollment targets in oncology trials and overcoming potential obstacles. Panelists shared perspectives on improving data quality, triangulating data from various sources, and addressing the challenge of inconsistent and incomplete data. The conversation also centered around the importance of addressing potential algorithmic bias in Artificial Intelligence (AI) and broadening diversity efforts to include aspects such as gender, sex, age, and social determinants of health. Many of these issues were emphasized in the meeting discussion document, which can be found here.
The panelists emphasized the need for collaboration between stakeholders, leveraging diverse voices, and setting achievable targets with operational tactics to ensure progress towards equity for diverse populations. Additionally, the speakers discussed operationalizing more inclusive research through real-world evidence (RWE), post-market commitments, and building collaboration and trust within communities through partnerships and using trusted messengers for raising awareness and educating underserved populations.
Session 2: Operational Approaches and Insights for More Inclusive Clinical Trials
(Click here to watch Session 2 discussions)
Session 2, moderated by Anjee Davis of Fight Colorectal Cancer, featured panelists Lucy Gansauer, SWOG Cancer Research Network & Spartanburg Regional Healthcare, Edward Kim, City of Hope Orange County and Friends Board Member, Kristi Mitchell, Atlas Clarity LLC & Health Equity Outcomes (HEO), and Nicole Richie, Genentech, Inc. The speakers, using their own diverse real-world experiences in enhancing diversity across public and private programs, discussed strategies for enhancing diversity in clinical trials, emphasizing trust-building in underrepresented communities. Key strategies discussed include training faith-based leaders, utilizing community health workers as clinical trial navigators, and routinely collecting data on the Social Determinants of Health.
The panel proposed a community-focused research organization to amplify underrepresented voices, empowering communities in the clinical trial processes. They noted the necessity of long-term investment and sustained engagement for effective community involvement. Examples of successful strategies were shared, such as the diversity plans implemented as part of the recently launched Pragmatica Lung clinical trial and City of Hope’s efforts to expand trial availability, as well as ongoing efforts lead by Friends and the American Society for Clinical Oncology to broaden eligibility criteria. Practical steps, like patient stipends and gift cards, to alleviate financial burdens on patients, increase representation, and create a feeling of mutual respect were highlighted. The discussion underscored the significance of community partnerships, long-term investment, and comprehensive solutions at major academic centers and community-based settings in addressing diversity challenges in clinical trials.
Click here to watch the full meeting.
Click here to access the meeting discussion document.
