This project investigates healthy volunteers’ patterns of participation in Phase I clinical trials, with particular attention to the differences among minority groups. The majority of healthy volunteers in clinical trials are serial participants, meaning that they enroll repeatedly in studies, so the research has a longitudinal design to understand volunteers’ patterns of participation in clinical trials. The project has four primary aims: (1) Assess how participants’ perceptions of the risks and benefits of Phase I participation change over time; (2) Examine how participants make decisions regarding their participation in clinical trials – including continuing serial participation – and assess the consistency of their choices over time; (3) Document how participants’ self-reported behaviors (a) affect the validity of clinical trials and (b) increase and/or mitigate harm that could come from serial participation, including behaviors that have health benefits; and (4) Compare participants’ perceptions, decisions, and behaviors across racial and ethnic groups. It is critical to understand the patterns of healthy volunteers’ participation in Phase I clinical trials, including differences in the participation of minority groups in these early-phase studies. Through this knowledge, efforts can be made to better protect the health of participants as well as to improve their understanding of the risks of serial participation in clinical trials. In addition, this project can help identify factors associated with serial participation that could affect the validity of clinical trials and potentially threaten the public’s health.
Funding: R01 GM099952, National Institute of General Medical Sciences, NIH