Development of a Safety Toolkit to Influence Inclusion Barriers for Adolescents and Young Adults (AYA) in Adult Clinical Trials.

Lack of long-term safety data for the AYA population has been identified as a key area that reduces enrolment of AYA in adult oncology clinical trials. Here we describe a potential safety assessment solution, from a pharmacovigilance and clinical patient safety perspective, to enhance the inclusion of adolescents into adult oncology trials. To help bridge gaps in safety data that limit AYA participation, a Patient Safety Oncology Toolkit for AYA patients has been developed. The safety toolkit includes recommended additional clinical study protocol templated wording for assessment and management of general AYA-related risks for oncology agents, including infertility, growth and development, new primary malignancies, and neurocognitive effects. There is also recommended language to incorporate into the study protocol for investigational product specific risk considerations based on impacted organ systems. Using the safety toolkit, a key deliverable from the evaluation of the risks is the generation of a safety go, or no-go, Red-Amber-Green (RAG) rating for each study. The RAG rating scale is intended to summarize the scope and severity of any specific treatment-related safety concerns and helps standardize company governance and investment decisions. This toolkit is intended to allow teams to safely include AYA individuals in adult oncology studies and allow this population better access to life-changing medicines.