CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary
Author:   Institute of Medicine ,  Board on Health Sciences Policy ,  Forum on Neuroscience and Nervous System Disorders ,  Bruce Altevogt
Publisher:   National Academies Press
ISBN:  

9780309148832


Pages:   88
Publication Date:   22 January 2011
Format:   Paperback
Availability:   In Print   Availability explained
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CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary


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Overview

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 Contents Front Matter Introduction 1 Perspectives from the FDA, Academia, and Patients 2 Data Collection and Optimization 3 Data Analysis 4 Partnerships, Opportunities, Collaboration Appendix A: References Appendix B: Workshop Agenda Appendix C: Workshop Attendees Appendix D: Biographical Sketches of Invited Speakers

Full Product Details

Author:   Institute of Medicine ,  Board on Health Sciences Policy ,  Forum on Neuroscience and Nervous System Disorders ,  Bruce Altevogt
Publisher:   National Academies Press
Imprint:   National Academies Press
ISBN:  

9780309148832


ISBN 10:   0309148839
Pages:   88
Publication Date:   22 January 2011
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Paperback
Publisher's Status:   Active
Availability:   In Print   Availability explained
This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us.

Table of Contents

1 Front Matter; 2 Introduction; 3 1 Perspectives from the FDA, Academia, and Patients; 4 2 Data Collection and Optimization; 5 3 Data Analysis; 6 4 Partnerships, Opportunities, Collaboration; 7 Appendix A: References; 8 Appendix B: Workshop Agenda; 9 Appendix C: Workshop Attendees; 10 Appendix D: Biographical Sketches of Invited Speakers

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