New FDA Draft Guidance on Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials

Draft Guidance published for receiving comments within 60 days

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 drugs2 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
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