ANTH627

Credit only granted for: ANTH427 or ANTH627. How are healthcare products developed today, and what is the role of the social and behavioral sciences in this process? An introduction to clinical research and the pathways through which medical products are approved by agencies such as the U.S. Food and Drug Administration (FDA). We examine the historical development of modern clinical research, regulatory requirements for approval of drugs, biologics, and medical devices, and current regulatory science issues that may be informed by the social and behavioral sciences (SBS). Students learn how theoretical frameworks and methodological tools from the SBS are applied in clinical research, with focus on topics such as "real world evidence," patient engagement, and digital health technologies. Students will apply knowledge learned to develop a deliverable suitable for a NGO, industry, or regulatory agency setting. In addition to the SBS, students from multiple disciplinary backgrounds interested in modern medical product development will find the course to be a relevant introduction to the field.