The purpose of this guidance is to provide the pharmaceutical industry, clinical investigators, and institutional review boards (IRBs) 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. FDA recommends the inclusion of adolescents in disease- and target-appropriate adult oncology trials to enable earlier access to investigational and approved drugs for adolescent patients with cancer. Considerations that are discussed in this guidance include:
– Appropriate criteria for the inclusion of adolescent patients in adult oncology trials at various stages of drug development
– Dosing and pharmacokinetic (PK) evaluations
– Safety monitoring
– Ethical requirements
The information in this guidance is meant to serve as a general guideline for sponsors considering this approach. Because specific details of an adult oncology drug development program that includes adolescents will vary depending on the characteristics and development