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GUIDANCE DOCUMENT

Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients March 2019

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Docket Number:
FDA-2019-D-0358
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Office of the Commissioner

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients.” This draft guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of drugs or biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for the treatment of cancer. Specifically, this guidance includes recommendations on the inclusion of pediatric patients (i.e., children and adolescents) in clinical trials for cancer treatments. Broadening cancer trial eligibility criteria can maximize the generalizability of trial results and the ability to understand the therapy's benefit-risk profile across the patient population likely to use the agent in clinical practice without jeopardizing patient safety.


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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-0358.