Educating Adolescents and Young Adults on Clinical Research and the Drug-Development Process: Can Public and Private Leaders Come Together to Deliver Greater Good?

Abstract

The development of new medical treatments for patients is limited by the challenges of recruiting clinical-research participants. In the United States, the Food and Drug Administration regulates the multidimensional approval process for new drugs, biologics, and medical devices to ensure consumer safety. The regulatory approval processes includes complex clinical trials that necessitate either healthy volunteers or patients who are willing to participate. The low enrollment rates of volunteers and patients willing to participate in clinical trials are resulting in significant delays in bringing new treatments to the market and substantially increasing development costs, for which consumers ultimately pay. The available research indicates that young adults and adolescents represent two of the lowest participating groups in clinical trials. Even though they are the next generation of consumers and patients, little to no research has examined the adolescent and young adult populations and their knowledge and perceptions of clinical research or their willingness to participate in clinical trials. Understanding these populations' perspectives and knowledge of the drug-development process and providing education regarding on this issue may have a profound, positive trickle-down effect on medicine, their personal well-being, and the well-being of the general public.

This study used a simple experimental design consisting of an intervention group and a control group. The intervention was a 10-minute educational video on participation in clinical research. Adolescents and young adults ( n = 527) were randomly distributed into the two groups. The knowledge, perceptions, and willingness to participate in clinical research were measured in both groups utilizing a 31-question survey instrument. The findings from this study may be used by educators, health care providers, patient advocacy groups, payers, and the pharmaceutical research and development industry to determine the best methods for educating adolescents and young adults on clinical research and trial participation.

The study concluded with a discussion of the importance of the role of leadership in social change and the process of igniting and sustaining such change. This process includes how, historically, public and private interests have come together to positively influence important public-health initiatives and, in turn, social change that holistically benefited all of society. Moving forward, leadership for social change could potentially deliver new and improved medical treatments in a timelier manner.