Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials; Draft Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials." The purpose of this draft guidance is to provide the pharmaceutical industry, clinical investigators, and institutional review boards with information to facilitate the inclusion of adolescent patients (for purposes of this draft guidance defined as ages 12 to 17) in relevant adult oncology clinical trials. The draft guidance focuses on appropriate criteria for inclusion in adult trials at various stages of drug development, considerations for dosing and pharmacokinetic evaluations, safety monitoring, and ethical requirements.