CityLab Promotes Understanding of Clinical Trials

描述(由申请人提供)：CityLab是一个以实践探究为基础的生物技术实验室项目，成立于1991年，自那时以来已为30多万名学生和3,000名教师提供了服务。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生物技术实验室(MobileLab)的发展，我们现在每年向大约7000名初中生和高中生教授我们的课程补充。城市实验室已成为地方和国家努力改善大学前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知识。在这项拟议的第I/II阶段计划中，我们会制订一项新的课程补充，包括动手实验室实验和电脑模拟，让9-12年级的学生和他们的老师对临床研究的基本元素有深入的了解和欣赏。为了实现这一点，我们将扩展CityLab最成功的课程补充之一，名为“弯曲细胞的谜团”。这份补充材料向学生传授导致镰状细胞性贫血的点突变，并通过让学生进行血红蛋白电泳来做到这一点。为了扩大这一课程补充材料，向学生传授临床试验，学生们将了解测试一种新的候选药物的重要性，这种药物可能通过重新激活编码形成胎儿血红蛋白的基因来逆转镰状细胞疾病的临床表现。将向学生介绍临床试验过程的几个关键要素，包括将实验室科学转化为临床舞台的重要性。临床研究阶段(I、II和III)将通过模拟调查进行解释。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”这些数据来展示他们的发现。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IRBs将被包括在内。整个计划将扩大到包括家长、教师和整个社区。我们的目标是让人们深刻认识到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。由于这一原有的课程补充已被广泛采用，这一外展模式的可行性已经确立。 公共卫生相关性(由申请者提供)：该项目将汇集高中教师和学生、科学家和教育工作者组成的团队，开发基于探究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相结合。课程补充将探索镰状细胞性贫血的分子基础和模拟临床试验干预。这些材料将教授学生以及他们的父母和社区成员基本的生物学内容，并将促进临床研究的参与。课程补编将在合作学校的试点研究中进行评估，最终形成一份可轻松传播给所有感兴趣的各方的最终成果。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对这些重要研究的参与而对公共健康产生巨大影响。

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.