The Science of Small Clinical Trials Course
FDA White Oak Campus, Silver Spring, Maryland, November 27–28, 2012
The first day focused on general principles and included six case studies of small drug, biologic and device trials that supported marketing approvals. Various techniques including Enrichment, Adaptive design and Bayesian statistical methods were highlighted. The second day provided an opportunity to focus on special considerations in the rare disease space, as well as topics including historical controls, the role of patient organizations, and the industry perspective. All sessions were enhanced by active learning methods and panel discussions with audience participation.
The course was well received and attendees noted that it provided a valuable training opportunity and included a breadth of expert knowledge and interesting dialogues.
Speaker presentations and webcast recordings are now available and can be accessed on the FDA_NIH Science of Small Clinical Trials Course website.