THANKS TO A WAVE OF NEWLY APPROVED DRUGS in the past two decades, survival rates for people with multiple myeloma—numbering more than 130,000 in the U.S.—have increased dramatically. But disparities among patients with multiple myeloma remain. African Americans have a two to three times higher rate of multiple myeloma than whites but make up a small fraction of clinical trial participants.
This gap in representation leaves us with important questions about the safety and efficacy of these treatments for African Americans. To address this issue, the American Association for Cancer Research (AACR) and the Food and Drug Administration (FDA) Oncology Center of Excellence brought together academic scientists, experts from the pharmaceutical industry, patients, physicians, statisticians and regulators to recommend policy changes to tackle these racial and ethnic disparities in multiple myeloma trials. (The AACR also publishes Cancer Today.)
On Feb. 13, 2020, the FDA and the AACR presented these recommendations in Washington, D.C., at the FDA-AACR Workshop to Examine Under-representation of African Americans in Multiple Myeloma Clinical Trials. These policy recommendations for improving representativeness and inclusion in trials will move the field of multiple myeloma treatment forward. Notably, despite the specific focus of the FDA-AACR initiative, we believe many of the policy recommendations can be applied broadly to any disease or malignancy with a disproportionate racial or ethnic burden.
These policy recommendations deal with a wide range of topics, including clinical trial design, community outreach and engagement, and how to use registry data to address specific questions in patient subpopulations. We recommend changes to how clinical trials are performed. Eligibility criteria for trials should be as broad as possible so that they will better reflect the patients treated with those drugs in the real world. If for some reason the eligibility criteria for a trial cannot be broad before the drug is approved by the FDA, post-approval trials should have broad eligibility criteria. Further, before conducting multiple myeloma clinical trials, trial sponsors should submit study plans to the FDA that set concrete targets for enrolling African Americans. These targets should match the disease incidence seen in the real world. (A clinical trial sponsor is “a person, company, institution, group or organization that oversees or pays for a clinical trial and collects and analyzes the data,” according to the National Cancer Institute.)
Making changes to how clinical trials are approached is critical, but the people conducting these trials must actively engage with the communities they seek to serve. One strategy to build community capacity is to reach out through organizations in the Black community that are not normally involved in clinical trial recruitment, such as churches, barbershops, and sororities and fraternities. Increasing the cultural competency of physicians referring patients to clinical trials and investigators running those trials is critical to addressing these issues. Further, we recommend that every phase II or phase III trial appoint a diversity officer. This professional, trained in cultural sensitivity and implicit bias, will help design recruitment strategies and focus on inclusion as the trial is executed.
Moving forward, we will work to turn these recommendations into real policy changes. Although this initiative is focused on African Americans with multiple myeloma, it is part of our greater responsibility to create a more inclusive, real-world paradigm for drug development. Everyone will feel more comfortable with new therapies if trial populations are more representative of real-world patients.
To see the recommendations or view the recording from this event, visit www.AACR.org/MMCT. To provide your feedback on the recommendations, email Elizabeth Barksdale, PhD, AACR assistant director of Regulatory Science and Policy.
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