Participants strengthen clinical trial research: the vital role of participant advisors in the Breast Cancer Prevention Trial.

Abstract

Views regarding the rights and roles of participants in clinical trial research have changed extensively over the past several decades. Such changes have included moving from paternalistic views, in which human subjects often were totally uninformed of research participation, to a perspective that recognized certain rights of human subjects. In recent years, the consumer rights movement, a growing customer service perspective in health care, and the growth of a variety of advocacy groups have brought further change in attitudes and efforts to include consumer representatives and research participants in a variety of advisory roles. The BCPT PAB is a model for a way to involve research study participants in an expanded role. Members of the board initiate efforts to promote participation and inform potential participants about the trial. They help establish outreach efforts to recruit individuals from underrepresented populations. They serve as effective spokespersons for the trial to the media at both local and national levels, and they give highly useful guidance to the NSABP and the NCI regarding a variety of aspects of clinical trials. Beyond the formal responsibilities that were outlined when the board was established, the trial participants serving on the advisory board also have provided inspiration and motivation for other participants as well as for the clinicians, researchers, and administrators conducting the BCPT. The extensive contributions of the advisory board members confirm and add to the understanding of the variety of ways that clinical research participants can play a role in strengthening such research efforts. Further, the BCPT PAB may serve as a model strategy for drawing on the unique resource represented by the participants in clinical trial studies.