Research Ethics and Policy Series (REPS): Representation of Adolescents and Young Adults in Clinical Trials

Including Adolescents and Young Adults Within Clinical Trials

Sneha Dave
Executive Director, Generation Patient

Lunch is provided for in-person attendees.
Livestreaming available via Zoom.

Clinical care has long treated young adults similarly to their older counterparts, despite mounting evidence that young adults experience different outcomes. As such, the momentum to increase diversity in clinical trials should ensure the inclusion and analysis of adolescents and young adult patients. The urgency to proactively address adolescents and young adults as a unique population within clinical trials has become increasingly apparent as disease diagnosis at earlier ages becomes more common. Furthermore, in many disease areas, the younger the person is living with the disease, the more aggressive the disease, thus drug disposition and safety signals may be different. This highlights the need for targeted clinical trials that are representative of young adults with these conditions.

By increasing the representation of young adults in clinical trials, we can improve their outcomes and work towards creating a more equitable healthcare system. The lack of adequate subgroup analysis especially when looking at systems such as the FDA Adverse Event Reporting System exacerbates the issue. Additionally, by including young adults in the drug development process, we can gain a better understanding of the unique challenges they face and tailor treatments accordingly.