P210: Development of a Safety Toolkit to Influence Inclusion Barriers for Adolescents and Young Adults in Adult Clinical Trials

Poster Presenter

Pamela Concepcion

Patient Safety Scientist
Astrazeneca
United States

Objectives

We have developed a safety assessment toolkit to address the challenge of inclusion of adolescent and young adult patients in adult clinical trials, to assist in allowing earlier access to novel oncology treatments.

Method

The safety assessment toolkit includes general risk considerations and organ-specific topic recommendations to address AYA-specific safety elements and determine the need to adjust adult oncology clinical trials for unique safety issues in the AYA population.

Results

Teams that use the toolkit are directed to obtain a Red-Amber-Green (RAG) score to determine overall safety and benefit/risk balance for the clinical study. A worked case example allowed for study inclusion of females from age 15-18 to enrol in an adult trial for a novel agent. The case example was given an Amber rating, due to the acknowledgment of long-term potential pulmonary and cardiac risks, that did not require adjustment of the protocol. The protocol was updated to monitor AYA for growth and sexual maturation. The result was younger subjects were permitted to be safely added to the ongoing trial.

Conclusion

Detailed safety assessment and mitigation processes will improve access to early phase, new molecular oncology modalities, with the hope of improving therapy outcomes for AYA patients. This toolkit, which facilitates a detailed and biology-based review to guide the need for risk mitigation and protocol adjustment for the inclusion of AYA oncology patients in clinical trials, aligns with current health authority expectations for expanding access for AYA patients in oncology trials while maintaining scientifically justified assessment of the safety benefits and potential risks in this population. The utility of the toolkit will be continually assessed and refined further based on additional regulatory feedback, for future protocols.