TGA – Considerations for the Inclusion of Adolescents in Adult Oncology Clinical Trials
On 28 February 2020, the TGA adopted the FDA Guidance for Industry: Considerations for the inclusion of adolescent patients in adult oncology clinical trials – click here to access.
This guidance 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 the guidance linked above 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