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，自那时以来已经为30多万名学生和3000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名中学生和高中生教授我们的课程补充。城市实验室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力范围，向学生传授临床研究知识。在第一/第二阶段的计划中，我们将开发一套新的课程补充，包括动手实验和计算机模拟，以使9-12年级的学生和他们的老师对临床研究的基本要素有一个敏锐的理解和欣赏。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“弯曲细胞的奥秘”。这个补充教学生关于点突变，负责镰状细胞性贫血，并通过让学生进行血红蛋白电泳做到这一点。为了扩展这门课程，教授学生临床试验，学生将了解测试一种新的候选药物的重要性，这种候选药物可能通过重新激活胎儿血红蛋白形成的基因来逆转镰状细胞病的临床表现。将向学生介绍临床试验过程的几个关键要素，包括将实验科学转化为临床领域的重要性。临床研究阶段（I， II和III）将通过模拟调查来解释。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”数据以展示他们的发现。将包括临床试验的其他重要方面，如患者权利保护、伦理、知情同意和内部审查委员会。整个项目将扩大到包括家长、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。由于这种原始的课程补充已被广泛采用，因此这种外展模式的可行性已经确立。

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.