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This study evaluates whether FDA-approved novel cancer therapeutics supported by pivotal trials with adequate representation of minoritized groups were associated with slower clinical development times than those with inadequate representation.
Conflict of Interest Disclosures: Dr Miller reported serving as a board member for Bioethics International, serving as an advisor for Galatea Bio, and receiving grants from the FDA outside the submitted work. Dr Ramachandran reported receiving consultancy fees from ReAct Action on Antibiotic Resistance Strategic Policy Program, grants from the Stavros Niarchos Foundations for a project on public research and development, and grants from the FDA for a research project on representation within clinical trials for oncology therapeutics outside the submitted work; and serving in volunteer, unpaid positions on the board for the nonprofit organization Universities Allied for Essential Medicines, North America, and as chair of the Doctors for America FDA Task Force. Dr Ross reported receiving grants from the FDA, Johnson & Johnson, Medical Devices Innovation Consortium, Agency for Healthcare Research and Quality, and National Heart, Lung, and Blood Institute; and having been an expert witness at the request of relator’s attorney, the Greene Law Firm, in a qui tam lawsuit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc that was settled September 2022. Dr Wallach reported receiving grants from the National Institute on Alcohol Abuse and Alcoholism, Johnson & Johnson (through the Yale Open Data Access Project), and the FDA, as well as consulting fees from Hagens Berman Sobol Shapiro LLP and Dugan Law Firm APLC outside the submitted work.
National Academies of Sciences, Engineering, and Medicine. Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups. National Academies Press; 2022. doi:10.17226/26479
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The Future of Medicine: Legislation to Encourage Innovation and Improve Oversight, Hearing Before the Subcommittee on Health; Committee on Energy and Commerce, 117th Cong, 2nd session (2022) (testimony of Lucy Vereshchagina, vice president, science and regulatory advocacy, Pharmaceutical Research and Manufacturers of America). Accessed October 1, 2023. https://docs.house.gov/meetings/IF/IF14/20220317/114510/HHRG-117-IF14-Ws...
Wong AK, Mooghali M, Ramachandran R, Ross JS, Wallach JD. Use of expedited regulatory programs and clinical development times for FDA-approved novel therapeutics. JAMA Netw Open. 2023;6(8):e2331753. doi:10.1001/jamanetworkopen.2023.31753
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