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. FDA recommends the inclusion of adolescent patients in disease- and target-appropriate adult oncology clinical trials to enable earlier access to investigational and approved drugs for adolescent patients with cancer. Topics that are discussed in this guidance include the following:

  • Appropriate criteria for the inclusion of adolescent patients in adult oncology clinical trials at various stages of drug development
  • Dosing and pharmacokinetic and pharmacodynamic evaluations
  • Safety monitoring
  • Ethical considerations

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 adolescent patients will vary depending on the characteristics and development stage of the drug and disease(s) under evaluation, sponsors are encouraged to contact the responsible FDA review division to discuss details of the program before implementation.

In addition, enrolling adolescent patients in adult oncology clinical trials may contribute toward addressing pediatric regulatory requirements under section 505A or 505B of the Federal Food, Drug, and Cosmetic Act. Details of these requirements should be discussed with the responsible FDA review division.

Posted on the FDA website on 12 March 2019