Children and Clinical Studies: A National Broadcast Film

描述(申请人提供)：“小灵通梅毒研究，危地马拉，威洛布鲁克，辐射实验……”尽管几十年来一直在努力提高研究对象的安全性，但这些话让人想起恐惧和对包括儿童在内的潜在研究参与者的虐待。卓越的研究对我们的健康和生活质量至关重要，然而，尽管许多潜在的参与者认识到临床研究的必要性，但他们避免参与。儿科临床试验的招募带来了独特的挑战，包括父母面临着是否允许孩子参加的决定的信息匮乏。尽管国家卫生研究院尽了最大努力帮助改善、告知和规范临床试验招募，但这些努力都是针对被要求让他们的CHID参与临床试验的父母。尽管做出了这些努力，但对临床研究早期众所周知的(但不具代表性的)错误、不当行为或滥用行为的误解、恐惧和神话仍然存在。由于证明需要有关临床研究的信息，临床研究对减少社会公正和差距的重要性，以及用于儿童但从未在儿童中进行试验的治疗之间的巨大差距，目前还没有全国性的广播节目来解决临床研究的复杂和重要问题，特别是在儿科人群中。这个Il SBIR阶段的应用程序的目标是开发一小时的原创叙事纪录片风格的电影，名为《不再牵着我的手：临床研究和儿童》。为了实现这一目标，我们将完成四个主要目标：目标1：与临床专家会面，并从完整电影的相关试验中确定家系。目标2：制作60分钟的广播片。目标3：对电影进行评估，为全国播出做准备。目标4：与WebMD合作开展全国广播和外联行动。

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.