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Inclusion of Older Adults in Cancer Clinical Trials Guidance for Industry March 2022

Docket Number:
Issued by:
Guidance Issuing Office
Oncology Center of Excellence
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

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.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-5572.


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