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# Cancer Trial Inclusion Guidance
- URL: https://www.fdaweb.com/cancer-trial-inclusion-guidance/
- Published: 2020-03-05T12:00:00.000Z
- Updated: 2026-09-14T16:06:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146251

FDA has published a draft guidance, *Inclusion of Older Adults in Cancer Clinical Trials*, with recommendations regarding the inclusion of older adult patients in clinical trials of drugs to treat cancer. Specifically, the [document](https://www.fda.gov/media/135804/download?ref=fdaweb.com) says it has recommendations for including an adequate representation of older adults in cancer clinical trials to better enable evaluation of the benefit/risk profile of cancer drugs in that population.

The guidance emphasizes the particular importance of including adults over age 75 in cancer clinical trials.

“Enrolling an adequate representation of the range of patients in a clinical trial that may be exposed to a drug after approval can maximize the generalizability of the trial results,” FDA says in the document. “It provides the ability to understand the drug’s benefit/risk profile across the patient population likely to use the drug in clinical practice (e.g., to identify whether there are differences in the benefits, risks, or both of the drug in different populations). Including information in the labeling describing use in older adults helps to promote the safe and effective use of these products and better informs treatment decisions in clinical practice.”