Real-World Data Of Cancer Drugs In Elderly Could Push Regulators Toward Broader Trial Eligibility

Medicare patients fared worse than pivotal trial populations on cancer drugs, two recent papers conclude, offering more ammunition for an increased regulatory focus on more generalizable trial populations. Current drug labels may portray an inaccurate risk-benefit calculation in older populations, which account for most cancer cases.

senior citizens playing cards
Real-world evidence shows older patients not getting trial-level benefits of cancer drugs. • Source: DCPhoto / Alamy Stock Photo

Recent real-world evidence studies that found Medicare patients fared worse on cancer drugs than patients in the clinical trials used for US Food and Drug Administration approval may help push the agency to require more study enrollment of the elderly.

FDA recently indicated it plans to begin a formal effort to encourage and inform drug development in older adults, with Center for Drug Evaluation and Research Deputy Director for Clinical Science Bob Temple saying that it may be possible to require enrollment of particular study populations through regulation

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