New Emphasis on Strategies to Increase Diversity in Clinical Trials

Clinical Trial: Clinical TrialThe Friends of Cancer Research (Friends) held a virtual meeting to examine recent initiatives to increase the diversity of clinical trial participants. The meeting featured panelists who focused on data-driven approaches to establishing diversity enrollment targets and operational approaches for achieving more inclusive clinical trials. According to a Friends briefing paper distributed before the meeting, about 8 percent of adult patients with cancer participate in clinical trials. The white paper notes there is often a lack of representation of patients in certain racial and ethnic populations in cancer clinical trials, despite the fact that patients in these groups bear a disproportionate burden of disease for several cancer types, including breast, prostate, and multiple myeloma. In a keynote address, Congressional Rep. Anna Eshoo (D-CA) noted that White patients make up most participants in clinical trials, despite an increasingly diversified U.S. population. More inclusive enrollment in trials is “not only fair and just; it's good science,” she said, to ensure the safety and efficacy of a new drug in all patient groups for whom it is intended. In 2022, Eshoo co-sponsored the DEPICT (Diverse and Equitable Participation in Clinical Trials) Act, which directed the FDA commissioner to amend certain regulations to increase clinical trial diversity. She cited FDA initiatives to implement guidance documents, including the new Project Equity, to boost diversity in oncology drug development trials. The Food and Drug Omnibus Reform Act (FDORA), passed in December 2022, enhances these efforts by requiring diversity action plans for Phase III clinical trials, which must consider race, ethnicity, age, and sex/gender. “I will hold the FDA responsible and make sure it holds up its end” on efforts to increase trial enrollment diversity, Eshoo said. Drug Sponsorship “The FDA has a long-standing commitment” to diversity, including ethnicity, age, race, and geography, said Namandjé N. Bumpus, PhD, Principal Deputy Commissioner at the FDA, in a second keynote address. She emphasized that, since FDORA requires diversity plans, drug sponsors should engage early and often with FDA staff during the process of drug development. Bumpus also stressed the need for drug sponsors to engage with the community to build relationships, increase diversity in trial enrollment, and adopt procedures to make trial participation more convenient, for example, through the use of digital health applications. Friends surveyed 23 drug sponsors to evaluate how they are implementing FDA guidance on diversity and the FDORA mandate to increase clinical trial diversity. Findings from this survey reveal that key steps toward making trial enrollment more diverse include characterizing the population of patients with a particular disease, identifying and analyzing diverse data sources, and setting enrollment goals. The Friends white paper stresses the importance of building trust and partnerships in diverse communities, lowering barriers to trial participation by addressing financial burdens and removing restrictive eligibility criteria, and choosing intentional trial site selections focusing on health centers serving diverse populations. It also makes two specific proposals to address challenges in data availability and integration: 1) Establish a central repository for biomarker data in the U.S. and Canada, which would include race and ethnicity data; and 2) Practice collaborative data consolidation efforts, which would consolidate and harmonize data sources to bridge gaps in data coverage and establish standards for collecting and reporting race and ethnicity variables. Patient Diversity Panelists also discussed the challenges, realities, and opportunities inherent in achieving a more diverse enrollment in clinical trials. For many years, diversity was not made a priority in drug development, said Lola Fashoyin-Aje, MD, MPH, Deputy Division Director in the Division of Oncology 3 at the FDA Office of Oncologic Diseases. Now, the organization has purposefully taken specific steps to boost diversity in the process of drug development, emphasized Fashoyin-Aje, who is also Program Lead for the new Project Equity at the FDA's Oncology Center of Excellence, a project which strives to increase access to oncology clinical trials for those in underrepresented populations. “FDA takes a broad view of what diversity is,” she noted, sharing that Project Equity is collaborating with the American Cancer Society on diversity data, especially for rare cancers. “We really take the diversity action plans very seriously,” said Henry Bennett, Global Clinical Operations Development Unit Head (Oncology & Hematology) at Novartis, noting the FDA is calling on industry to make a measurable difference in increasing the diversity of clinical trials. To that end, he said that once the company has established diversity targets, which start early in the drug development process, the company tracks those targets. He noted that, while they run global trials, the company strives to have a footprint that represents the diversity of the U.S. population. Artificial intelligence (AI) digital tools can help find diverse candidates for clinical trial enrollment, said Cleo A. Ryals, PhD, Head of Health Equity Research at Flatiron Health. She noted AI tools can also help identify trial site locations that enhance diverse enrollment. However, she cautioned that such AI tools have to be developed rigorously so they do not perpetuate existing biases that might defeat the whole purpose of trying to achieve more diversity in clinical trial enrollment. Panelists at the Friends meeting repeatedly emphasized the importance of establishing trust with potential trial participants from diverse populations. “You have to show up in your community,” said Edward S. Kim, MD, MBA, Physician-in-Chief at the City of Hope Orange County. “We have to build trust by the care that we provide.” He noted that City of Hope, which is expanding nationally, participates in community events and believes it's important that the composition of the staff fit the patient demographics of the area being served. Kim said City of Hope has made it a priority to make sure all patients are offered a clinical trial when it is available, noting that he has developed a digital tool to help link patients to appropriate trials. Kim put in a plea for making trials less complicated and less restrictive in eligibility requirements. “We have to be able to be more broad in our eligibility,” he said. Working with “trusted brokers”—physicians with experience in helping underrepresented populations—helps enhance trial diversity, said Nicole Richie, PhD, Vice President and Global Head Health of Equity and Population Science at Genentech. She said it is a myth that enrolling for diversity slows down a clinical trial. On the contrary, she noted partnerships with the right physicians make the enrollment process go faster. The role of trusted messengers within a community cannot be overstated, agreed Kristi Mitchell, MPH, Founder and Principal at Atlas Clarity LLC and CEO of Health Equity Outcomes. Community engagement is not a short-term solution and requires major investment, she stressed. Agreeing was Lucy Gansauer, MSN, RN, OCN, CCRP, the DEI Champion at SWOG Cancer Research Network & Spartanburg Regional Healthcare. “Intentionality works when you use evidence-based strategies,” she said, describing how she and her colleagues adopted an 18-point plan to accrue underserved populations. This plan drove overall accrual for a win-win. She also cited the value of stipends to help patients participate in clinical trials, noting that many of them have real financial needs. In its Cancer Research Progress Report 2023, the American Association for Cancer Research cited the National Cancer Institute's Community Oncology Research Program—“a national network that brings cancer clinical trials and care delivery studies to people in their own communities.” The report, which contains information on U.S. cancer inequities, added, “All research and clinical trials should be conducted with consideration for every patient. This means reaching out to and involving individuals in previously neglected regions of the country.” Peggy Eastman is a contributing writer.

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