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CNS clinical trials : suicidality and data collection : workshop summary / Sarah Hanson, Miriam Davis, and Bruce Altevogt ; Forum on Neuroscience and Nervous System Disorders, Board on Health Sciences Policy.

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Format:
Book
Author/Creator:
Hanson, Sarah.
Contributor:
Institute of Medicine (U.S.). Forum on Neuroscience and Nervous System Disorders.
National Academies Press (U.S.)
Davis, Miriam.
Altevogt, Bruce M.
Language:
English
Subjects (All):
Suicide--Risk factors.
Suicide.
Suicide--Prevention.
Physical Description:
xii, 75 p.
Edition:
1st ed.
Place of Publication:
Washington, D.C. : National Academies Press, 2010.
Language Note:
English
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.
Contents:
Perspectives from the FDA, academia, and patients
Data collection and optimization
Data analysis
Partnerships, opportunities, collaboration.
Notes:
Bibliographic Level Mode of Issuance: Monograph
ISBN:
9786612975912
9780309186483
030918648X
9781282975910
1282975919
9780309148849
0309148847
OCLC:
709768285

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