tailieunhanh - CNS Clinical Trials Suicidality And Data Colection

The Institute of Medicine’s 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. 2 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. | 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 THE NATIONAL ACADEMIES PRESS Washington . THE NATIONAL ACADEMIES PRESS 500 Fifth Street . Washington DC 20001 NOTICE The project that is the subject of this report was approved by the Governing Board of the National Research Council whose members are drawn from the councils of the National Academy of Sciences the National Academy of Engineering and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This project was supported by contracts between the National Academy of Sciences and the Alzheimer s Association AstraZeneca Pharmaceuticals Inc. CeNeRx Biopharma the Department of Health and Human Services National Institutes of Health NIH Contract No. N01-OD-4-213 through the National Institute on Aging the National Institute on Alcohol Abuse and Alcoholism the National Institute on Drug Abuse the National Eye Institute the NIH Blueprint for Neuroscience Research the National Institute of Mental Health the National Institute of Neurological Disorders and Stroke Eli Lilly and Company GE Healthcare Inc. GlaxoSmithKline Inc. Johnson Johnson Pharmaceutical Research and Development LLC Merck Research Laboratories the National Multiple Sclerosis Society the National Science Foundation Contract No. OIA-0753701 the Society for Neuroscience and Wyeth Research Inc. The views presented in this publication are those of the editors and attributing authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project. International Standard Book Number-13 978-0-309-14883-2 International Standard Book Number-10 0-309-14883-9 Additional copies of this .

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• Causal Relationships Clinical Trials
• Selection Bias
• Indication
• Meta Analyses
• Observational Studies