Project Summary 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.

Project Narrative 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.