CNS Clinical Trials. Suicidality and Data Collection. Workshop Summary

摘要

The Institute of Medicines Forum on Neuroscience and Nervous System Disorders planned and held a public workshop June 16, 2009, that brought together experts from industry, academia, government, and advocacy groups to discuss issues directly related to a recent Food and Drug Administration (FDA) policy that all clinical protocols for products developed in the Division of Psychiatry Products (of the FDA) include a prospective assessment for suicidality. Given the focus of the Forum, participants were charged with examining and discussing currently available data, data analysis, and the future of potential partnerships that will be or are being impacted by this announcement as it relates to clinical trials involving the nervous system. Discussions centered on the critical areas of further examination and analysis needed.