Division of Clinical Research

Office of the Vice President and Innovation

3/6/2020 – Inclusion of Older Adults in Cancer Clinical Trials: Draft Guidance for Industry

This guidance provides recommendations regarding the inclusion of older adult patients in clinical trials of drugs for the treatment of cancer.  For the purpose of this guidance, older adults are those aged 65 years and older.  Specifically, this guidance includes 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 this population.  The guidance emphasizes the particular importance of including adults over age 75 years in cancer clinical trials.  This guidance is intended to assist stakeholders, including sponsors and institutional review boards, responsible for the development and oversight of 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.  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.

Categories FDA Regulatory, Policies & Guidance
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