Children and Clinical Studies: A National Broadcast Film

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DESCRIPTION (provided by applicant): "The PHS Syphilis Study, Guatemala, Willowbrook, radiation experiments..." Despite decades of work to improve the safety of research subjects, these words bring to mind images of fear and the mistreatment of potential research participants, including children. Excellence in research is essential to our health and quality of life, yet while many potential participants recognize the need for clinical studies, they avoid participating. Recruitment for pediatric clinical trials presents unique challenges, including a lak of information for parents faced with a decision about whether to allow a child to participate. Despite best efforts of the National Institutes of Health to help improve, inform and standardize clinical trial recruitment these efforts are targeted to parents who are asked to involve their chid in a clinical trial. Misperceptions, fears and myths about the well-known (but not representative) mistakes, misconduct or abuse from the earliest days of clinical research persist regardless of these efforts. With demonstrated need for information about clinical research, the importance of clinical research to reduce social justice and disparities, and the vast gap between treatments used with children but never tested in children, no national broadcast program yet exists which has tackled the complex and important issue of clinical studies particularly in pediatric populations. The goal of this Phase Il SBIR application is to develop the one-hour, original narrative documentary-style film entitled, No More Hand Me Downs: Clinical Research and Children. To accomplish this goal, we will complete four major Aims: Aim 1: To meet with clinical experts and identify families from related trials for the complete film. Aim 2: Develop the 60 minute broadcast film. Aim 3: Conduct an evaluation of the film in preparation for national broadcast. Aim 4: Conduct national broadcast and outreach operations in collaboration with WebMD.