CNS Clinical Trials

The Food and Drug Administration (FDA) now requires that all clinical trials for drugs that affect the central nervous system—including psychiatric drugs—are assessed for whether that drug might cause suicidal ideation or behavior. The Institute of Medicine's (IOM) Forum on Neuroscience and Nervous System Disorders hosted a meeting on June 26, 2009, to discuss the FDA's new policy and how to analyze best whether suicidal thoughts predict actual suicidal behavior in the near future.Table of ContentsFront MatterIntroduction1 Perspectives from the FDA, Academia, and Patients2 Data Collection and Optimization3 Data Analysis4 Partnerships, Opportunities, CollaborationAppendix A: ReferencesAppendix B: Workshop AgendaAppendix C: Workshop AttendeesAppendix D: Biographical Sketches of Invited Speakers