Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients; Guidance for Industry and Institutional Review Boards; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry and institutional review boards (IRBs) entitled "Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients." This 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. This guidance finalizes the draft guidance entitled "Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients" that published on March 13, 2019.