Originally published by Clinical Leader, March 3, 2022.

Guest Author: Marjorie E. Zettler, Ph.D., MPH, director of clinical science, Regor Pharmaceuticals, Inc.

By now, the lack of diversity in clinical trials of cancer therapies approved by the FDA has been well described. Studies have repeatedly shown that in the trials that support FDA approval of new cancer treatments, certain races and ethnicities are underrepresented, women are underrepresented, and older adults are underrepresented.1-4 Adequate representation of the patient populations who will eventually receive the therapy is crucial to accurately detect possible differences in both efficacy and safety in subpopulations. More inclusive clinical trials produce results with greater generalizability and that better reflect the treatment effects that can be expected with real-world use.

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