Increase Representation of the Elderly in Cancer Trials, FDA Guidance Says

March 13, 2020

The FDA is encouraging cancer trials to pay greater attention to patients aged 75 and older, according to a new draft guidance.

Adults age 65 and older, especially those over 75, are underrepresented in clinical research on cancer despite comprising a growing portion of the cancer patient population, the agency said.

Sponsors need to discuss their enrollment goals with sites and investigators to achieve greater participation of elderly patients. The guidance also recommends recruiting more physicians specializing in geriatric oncology as investigators.

Because outcomes of cancer patients aged 65 and older may vary by age, the guidance encourages sponsors to evaluate data by subgroups, for example patients age 65 to 74 vs. patients age 75 or older.

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