National Academies Press: OpenBook
Suggested Citation:"Front Matter." Institute of Medicine. 2010. CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12829.
×

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, D.C.
www.nap.edu

Suggested Citation:"Front Matter." Institute of Medicine. 2010. CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12829.
×

THE NATIONAL ACADEMIES PRESS
500 Fifth Street, N.W.
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 report are available from the

National Academies Press,

500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu.

For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu.

Copyright 2010 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

Suggested citation: IOM (Institute of Medicine). 2010. CNS clinical trials: Suicidality and data collection: Workshop summary. Washington, DC: The National Academies Press.

Suggested Citation:"Front Matter." Institute of Medicine. 2010. CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12829.
×

“Knowing is not enough; we must apply.

Willing is not enough; we must do.”

–Goethe

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

Advising the Nation. Improving Health.

Suggested Citation:"Front Matter." Institute of Medicine. 2010. CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12829.
×

THE NATIONAL ACADEMIES

Advisors to the Nation on Science, Engineering, and Medicine


The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences.


The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering.


The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine.


The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.


www.national-academies.org

Suggested Citation:"Front Matter." Institute of Medicine. 2010. CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12829.
×

WORKSHOP ON CNS CLINICAL TRIALS: SUICIDALITY AND DATA COLLECTION PLANNING COMMITTEE*

WILLIAM POTTER (Co-chair),

Merck Research Laboratories

ROBERT GIBBONS (Co-chair),

University of Illinois at Chicago

CHARLES BEASLEY, JR.,

Eli Lilly and Company

DAVID BRENT,

University of Pittsburgh School of Medicine

YEATES CONWELL,

University of Rochester School of Medicine and Dentistry

WALTER KOROSHETZ,

National Institute of Neurological Disorders and Stroke

THOMAS LAUGHREN,

Food and Drug Administration

HUSSEINI MANJI,

Johnson & Johnson Pharmaceutical Research and Development, LLC

DAVID MICHELSON,

Merck & Co.

ATUL PANDE,

GlaxoSmithKline, Inc.

PHILIP WANG,

National Institutes of Health

IOM Staff

BRUCE ALTEVOGT,

Project Director

SARAH HANSON,

Associate Program Officer

LORA TAYLOR,

Senior Project Assistant

*

IOM planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.

Suggested Citation:"Front Matter." Institute of Medicine. 2010. CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12829.
×

This page intentionally left blank.

Suggested Citation:"Front Matter." Institute of Medicine. 2010. CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12829.
×

FORUM ON NEUROSCIENCE AND NERVOUS SYSTEM DISORDERS*

ALAN LESHNER (Chair),

American Association for the Advancement of Science

HUDA AKIL,

University of Michigan

MARC BARLOW,

GE Healthcare, Inc.

MARK BEAR,

Massachusetts Institute of Technology

DANIEL BURCH,

CeNeRx Biopharma

DENNIS CHOI,

Emory University

TIMOTHY COETZEE,

National Multiple Sclerosis Society

DAVID COHEN,

Columbia University

RICHARD FRANK,

GE Healthcare, Inc.

JOHN GRIFFIN,

Johns Hopkins University School of Medicine

RICHARD HODES,

National Institute on Aging

KATIE HOOD,

Michael J. Fox Foundation for Parkinson’s Research

STEVEN HYMAN,

Harvard University

THOMAS INSEL,

National Institute of Mental Health

STORY LANDIS,

National Institute of Neurological Disorders and Stroke

HUSSEINI MANJI,

Johnson & Johnson Pharmaceutical Research and Development, LLC

EVE MARDER,

Brandeis University

JONATHAN MORENO,

University of Pennsylvania School of Medicine

MICHAEL OBERDORFER,

NIH Neuroscience Blueprint

KATHIE OLSEN,

National Science Foundation

ATUL PANDE,

GlaxoSmithKline, Inc.

MENELAS PANGALOS,

Wyeth Research, Inc.

STEVEN PAUL,

Eli Lilly and Company

WILLIAM POTTER,

Merck Research Laboratories

PAUL SIEVING,

National Eye Institute

RAE SILVER,

Columbia University

WILLIAM THIES,

Alzheimer’s Association

NORA VOLKOW,

National Institute on Drug Abuse

KENNETH WARREN,

National Institute on Alcohol Abuse and Alcoholism

*

IOM forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.

Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2010. CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12829.
×

FRANK YOCCA,

AstraZeneca Pharmaceuticals, Inc.

STEVIN ZORN,

Lundbeck USA

CHARLES ZORUMSKI,

Washington University School of Medicine

IOM Staff

BRUCE ALTEVOGT, Forum Director

SARAH HANSON, Associate Program Officer

LORA TAYLOR, Senior Project Assistant

ANDREW POPE, Director,

Board on Health Sciences Policy

Suggested Citation:"Front Matter." Institute of Medicine. 2010. CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12829.
×

Reviewers

This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We wish to thank the following individuals for their review of this report:

Charles Beasley, Jr., Lilly Research Laboratories

Eric Caine, University of Rochester Medical Center

Joel B. Greenhouse, Carnegie Mellon University

Robert Temple, Food and Drug Administration

Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the report before its release. The review of this report was overseen by Dr. Charles F. Reynolds. Appointed by the Institute of Medicine, he was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

Suggested Citation:"Front Matter." Institute of Medicine. 2010. CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12829.
×

This page intentionally left blank.

Suggested Citation:"Front Matter." Institute of Medicine. 2010. CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12829.
×
Suggested Citation:"Front Matter." Institute of Medicine. 2010. CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12829.
×
Page R1
Suggested Citation:"Front Matter." Institute of Medicine. 2010. CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12829.
×
Page R2
Suggested Citation:"Front Matter." Institute of Medicine. 2010. CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12829.
×
Page R3
Suggested Citation:"Front Matter." Institute of Medicine. 2010. CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12829.
×
Page R4
Suggested Citation:"Front Matter." Institute of Medicine. 2010. CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12829.
×
Page R5
Suggested Citation:"Front Matter." Institute of Medicine. 2010. CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12829.
×
Page R6
Suggested Citation:"Front Matter." Institute of Medicine. 2010. CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12829.
×
Page R7
Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2010. CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12829.
×
Page R8
Suggested Citation:"Front Matter." Institute of Medicine. 2010. CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12829.
×
Page R9
Suggested Citation:"Front Matter." Institute of Medicine. 2010. CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12829.
×
Page R10
Suggested Citation:"Front Matter." Institute of Medicine. 2010. CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12829.
×
Page R11
Suggested Citation:"Front Matter." Institute of Medicine. 2010. CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12829.
×
Page R12
Next: Introduction »
CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary Get This Book
×
Buy Paperback | $21.00 Buy Ebook | $16.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

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.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!