Excerpt

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 this announcement as it relates to clinical trials involving the nervous system. Discussions centered on the critical areas of further examination and analysis needed.

Contents

• The National Academies
• Workshop on CNS Clinical Trials: Suicidality and Data Collection Planning Committee
• Forum on Neuroscience and Nervous System Disorders
• Reviewers
• Introduction
  • BACKGROUND ON THE ISSUES
  • ABOUT THE FORUM AND WORKSHOP
• 1. Perspectives from the FDA, Academia, and Patients
  • FDA PERSPECTIVE
  • PERSPECTIVE ON METHODOLOGY DEVELOPMENT AND IMPLEMENTATION
  • PERSPECTIVE OF PATIENTS AND FAMILIES
• 2. Data Collection and Optimization
  • NEW APPROACHES TO STUDYING THE PREDICTIVE POWER OF SUICIDAL IDEATION FOR SUICIDALITY
  • REAL-TIME ELECTRONIC MONITORING SYSTEMS
  • THE PREDICTIVE VALIDITY OF SUICIDE IDEATION AT ITS WORST POINT IN TIME FOR SUICIDE ATTEMPTS
  • NEUROBIOLOGICAL CONTRIBUTIONS TO PREDICTING SUICIDALITY
• 3. Data Analysis
  • ESTABLISHING CAUSAL RELATIONSHIPS IN MEDICINE FOR PUBLIC HEALTH POLICY
  • BENEFITS AND LIMITATIONS OF META-ANALYSES
  • SOURCES OF BIAS IN ANTIDEPRESSANT CLINICAL TRIALS
• 4. Partnerships, Opportunities, Collaboration
  • CORE DATA TO OBTAIN FOR DATA SHARING
  • THE FDA’S CRITICAL PATH INITIATIVE
  • A PROPOSAL FOR THE FDA’S CRITICAL PATH INITIATIVE UNDER DEVELOPMENT FOR SUICIDALITY
• Appendixes
  • A References
  • B Workshop Agenda
  • C Workshop Attendees
  • D Biographical Sketches of Invited Speakers

Rapporteurs: Sarah Hanson, Miriam Davis, and Bruce Altevogt

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-4-2139) 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.

Suggested citation:

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

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.

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.