Establishing a cancer clinical trial with age eligibility encompassing adolescents and young adults (AYA), this guide provides the ethical approval processes required to establish a multi-centre cancer investigator-initiated trial open to participants both over and under the age of 18 years.
This procedure aims to provide paediatric cancer centre staff with a transparent, equitable and clear process to apply to hospital executive for permission to transfer young adults with a paediatric-type cancer to the paediatric cancer centre to access a paediatric cancer clinical trial.
The SOP requires the completion of an access request form that provides hospital executive with the information they require to assess each request on a patient-by-patient basis.
A guide to the establishment of collaborative craft groups across paediatric and adult oncology (adolescent and young adult craft groups) to advance the care of young people with cancer.
This guidance provides 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 12-17) in relevant adult oncology clinical trials.
The guidance focuses on appropriate patient selection criteria for the inclusion of adolescent patients in adult oncology clinical trials at various stages of drug development, considerations for dosing and pharmacokinetic evaluations, safety monitoring, and ethical considerations.