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GUIDANCE DOCUMENT

Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials March 2019

Draft

Not for implementation. Contains non-binding recommendations.

Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials

Docket Number:
FDA-2018-D-1540
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 final guidance for industry entitled “Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials.” The purpose of this guidance is to provide the pharmaceutical industry, clinical investigators, and institutional review boards with information to facilitate the inclusion of adolescent patients (for purposes of this guidance, defined as ages 12 to 17) in relevant adult oncology clinical trials. The guidance focuses on appropriate patient selection criteria for the inclusion of adolescent patients in adult oncology clinical trials at various stages of drug development, considerations for dosing and pharmacokinetic evaluations, safety monitoring, and ethical considerations.


Submit Comments

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:

Division of Dockets Management (HFA- 305)
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-2018-D-1540.