CNS clinical trials : suicidality and data collection : workshop summary / Sarah Hanson, Miriam Davis and Bruce Altevogt, rapporteurs ; Forum on Neuroscience and Nervous System Disorders, Board on Health Sciences Policy, Institute of Medicine of the National Academies.
Includes bibliographical references (pages 43-49).
Contents
Perspectives from the FDA, academia, and patients -- Data collection and optimization -- Data analysis -- Partnerships, opportunities, collaboration.
Summary
"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."--Publisher's description.
Local Note
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