CityLab Promotes Understanding of Clinical Trials

描述（由申请人提供）：CityLab是一个基于实践调查的生物技术实验室计划，成立于1991年，自那时以来已为30多万名学生和3,000名教师提供服务。CityLab在波士顿大学医学院有两个专门的实验室，随着其非常成功的移动的生物技术实验室（MobileLab）的发展，我们现在每年向大约7，000名初中和高中学生教授我们的课程补充。CityLab已经成为地方和国家努力改善大学预科科学教育的成功典范。CityLab现在寻求扩大其影响范围，向学生传授临床研究。在这个拟议的第一/第二阶段项目，我们将开发一个新的课程补充，包括动手实验室实验和计算机生成的模拟传授临床研究的基本要素，在9-12年级的学生和他们的老师敏锐的理解和欣赏。为了实现这一目标，我们将扩展CityLab最成功的课程补充之一，名为“弯曲细胞之谜”。这一补充教导学生点突变，是负责镰状细胞贫血症，它这样做，让学生进行血红蛋白电泳。为了扩大这门课程的补充，教学生有关临床试验，学生将了解测试一种新的候选药物的重要性，这种候选药物可以通过重新激活编码胎儿血红蛋白形成的基因来逆转镰状细胞病的临床表现。学生将被介绍到临床试验过程中的几个关键要素，包括将实验室科学转化为临床竞技场的重要性。将通过模拟研究解释临床研究阶段（I、II和III）。特别是，学生将设计和分析来自模拟大型临床试验的数据，学生将“挖掘”数据以展示他们的发现。将包括临床试验的其他重要方面，如保护患者权利、伦理、知情同意和IRB。整个方案将扩大到包括家长、教师和整个社区。我们的目标是深刻理解公民参与临床试验的重要性以及临床试验产生的数据的重要性。由于这一最初的课程补充已被广泛采用，这一推广模式的可行性已得到很好的确立。 公共卫生相关性（由申请人提供）：该项目将汇集一个高中教师和学生，科学家和教育工作者的团队，开发一个基于调查的实验室科学课程补充，将临床试验推广和教育的最佳实践与合理的科学内容和教学法相结合。课程补充将探讨镰状细胞性贫血从其分子基础，以模拟临床试验干预。这些材料将向学生及其家长和社区成员讲授基本的生物学内容，并将促进他们参与临床研究。将在合作学校的试点研究中对课程补充材料进行评估，最终形成一个易于向所有有关各方传播的产品。由于目前很少有成年人参加临床试验，这些材料可能会通过增加这些重要研究的参与对公共卫生产生巨大影响。

DESCRIPTION (provided by applicant): CityLab is a hands-on inquiry based biotechnology laboratory program that was organized in 1991 and has served more than 300,000 students and 3,000 teachers since that time. CityLab has two dedicated laboratories at Boston University School of Medicine and, with the development of its very successful mobile biotechnology laboratory (MobileLab), we now teach our curriculum supplements to approximately 7,000 middle and high school students per year. CityLab has become a successful model for both local and national efforts to improve pre-college science education. CityLab now seeks to expand its sphere of influence to teach students about clinical research. During this proposed Phase I/II project, we will develop a new curriculum supplement that includes both hands-on laboratory experiments and computer-generated simulations to impart a keen understanding and appreciation of the basic elements of clinical research to students in grades 9-12 and their teachers. To accomplish this, we will expand one of CityLab's most successful curriculum supplements entitled "The Mystery of The Crooked Cell". This supplement teaches students about the point mutation that is responsible for sickle cell anemia and it does so by engaging students to perform hemoglobin electrophoresis. To expand this curriculum supplement to teach students about clinical trials, students will learn about the importance of testing a novel drug candidate that may reverse the clinical manifestations of sickle cell disease by reactivating the gene that codes for the formation of fetal hemoglobin. Students will be introduced to several critical elements of the clinical trial process including the importance of translating bench science into the clinical arena. The clinical investigation phases (I, II, and III) will be explained through simulated investigations. In particular, students will design and analyze data from a simulated large clinical trial and students will "mine" the data to present their findings. Other important aspects of clinical trials such as the protection of patient rights, ethics, informed consent and IRBs will be included. The entire program will be expanded to include parents, teachers and the community at large. Our goal is to impart a deep appreciation of the importance of citizen participation in clinical trials and the importance of the data generated by a clinical trial. Since this original curriculum supplement has been widely adopted, the viability of this outreach model is well established. PUBLIC HEALTH RELEVANCE (provided by applicant): This project will bring together a team of high school teachers and students, scientists, and educators to develop an inquiry-based laboratory science curriculum supplement that integrates best practices from clinical trials outreach and education with sound science content and pedagogy. The curriculum supplement will explore sickle cell anemia from its molecular basis to a simulated clinical trial intervention. The materials will teach students, as well as their parents and members of their communities, essential biology content and will promote participation in clinical studies. The curriculum supplement will be evaluated in pilot studies in collaborating schools, leading to a final product that can be easily disseminated to all interested parties. Since few adults currently enroll in clinical trials, these materials may have a dramatic impact on public health by increasing the participation in these important studies.