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

CNS Clinical Trials: Suicidality and Data Collection


Tuesday, June 16, 2009

National Academy of Sciences Main Building

Lecture Room

2101 Constitution Avenue, NW

Washington, DC


Workshop Objectives

The purpose of the workshop is to determine whether treatment-emergent suicidal ideation predicts suicidal behavior in the near term for conduct of clinical trials. It examines what methods are optimal and whether potential partnerships can facilitate data sharing among the Food and Drug Administration (FDA), pharmaceutical industry, academia, and the National Institutes of Health (NIH).

  • Review available data on the extent to which emergent suicidal ideation predicts the occurrence of actual suicidal behavior, particularly in the short term.

  • Ascertain optimal methods of analysis to address if suicidal ideation predicts the short-term occurrence of actual suicidal behavior.

Suggested Citation:"Appendix B: Workshop Agenda." Institute of Medicine. 2010. CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12829.
×
  • Examine potential partnerships among the FDA, pharmaceutical industry, academia, and the NIH that could be used to facilitate data sharing from randomized clinical trials.

9:00 a.m.

Welcome, Introductions, and Workshop Objectives

 

WILLIAM POTTER, Workshop Co-chair

Vice President

Clinical Neuroscience

Merck Research Laboratories

Merck & Co., Inc.

 

ROBERT GIBBONS, Workshop Co-chair

Director, Center for Health Statistics

Professor of Biostatistics and Psychiatry

University of Illinois at Chicago

9:15 a.m.

FDA Policies and Perspectives: Suicidality Studies in IND

 

THOMAS LAUGHREN

Director

Division of Psychiatry Products

Food and Drug Administration

9:35 a.m.

C-CASA and C-SSRS in CN S Clinical Trials: Development and Implementation

 

KELLY POSNER

Director

Center for Suicide Risk Assessment

New York State Psychiatric Institute

9:55 a.m.

Perspectives from the Patient Community

 

GAIL GRIFFITH

Consumer Representative

Food and Drug Administration’s

Psychopharmacological Drug Advisory Committee

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

SESSION I:
DATA COLLECTION AND OPTIMIZATION

Session Objective: Review available data on the extent to which emergent suicidal ideation predicts the occurrence of actual suicidal behavior, particularly in the short term (during an index of treatment period that typically lasts between 4 and 16 week s). Discuss optimization of methods for data collection as well as if there is a need for additional data collection, in addition to C-SSRS data, to help address the question of this potential relationship.

10:10 a.m.

Introduction to the Session

 

DAVID BRENT, Session Chair

Professor

Department of Psychiatry

University of Pittsburgh School of Medicine

10:15 a.m.

Panel Discussion: Assessing the Risk Between Ideation and Action (Each presentation approximately 15 minutes)

 

Frequency with Which Suicide (or Serious Attempts) Is Preceded by Expressed Ideation: A Literature Review

 

MATTHEW NOCK

Associate Professor of Social Sciences

Department of Psychology

Harvard University

 

Measurement of Suicide Ideation

 

GREGORY BROWN

Research Associate Professor of Clinical Psychology in Psychiatry

Department of Psychiatry

University of Pennsylvania

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

 

Treatment Emergent Suicidal Events in Adolescents: Neurobiology and Clinical Significance

 

J. JOHN MANN

Professor of Translational Neuroscience, Psychiatry, and Radiology

Columbia University

Chief, Department of Neuroscience

New York State Psychiatric Institute

11:00 a.m.

Moderated Discussion with Attendees

 

DAVID BRENT, Session Chair

Professor

Department of Psychiatry

University of Pittsburgh School of Medicine

 

Discussion Questions:

 

  • Does the C-SSRS measure what it says it measures?

  • Are there outcomes that should be assessed but are not?

  • What conditions (type of interview, spontaneous vs. systematic) would optimize assessment?

  • What are the public health implications of the events detected by the C-SSRS?

11:45 a.m.

LUNCH

SESSION II:
DATA ANALYSIS

Session Objective: Discuss optimal methods for meta-analyses for instances where the outcome of interest is very infrequent. In addition, ascertain optimal methods of analysis to address if suicidal ideation predicts the short-term occurrence of actual suicidal behavior.

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

12:45 p.m.

Introduction to the Session

 

ROBERT GIBBONS, Session Chair

Director, Center for Health Statistics

Professor of Biostatistics and Psychiatry

University of Illinois at Chicago

12:50 p.m.

Panel Discussion: Data Analysis Strategies (Each presentation approximately 15 minutes)

 

Potential Drawbacks in Existing Methodologies

 

JOEL GREENHOUSE

Professor

Department of Statistics

Carnegie Mellon University

 

Design and Analytic Strategies for Modeling Suicidality

 

ROBERT GIBBONS

Director, Center for Health Statistics

Professor of Biostatistics and Psychiatry

University of Illinois at Chicago

 

Design and Analytic Strategies for Modeling Suicidality: An FDA Perspective

 

MARC STONE

Senior Medical Reviewer

Division of Psychiatry Products

Food and Drug Administration

 

Studying Suicidality: From RCTs to OCER

 

ROBERT VALUCK

Professor

Department of Clinical Pharmacy

University of Colorado at Denver

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

1:50 p.m.

Moderated Discussion with Attendees

 

ROBERT GIBBONS, Session Chair

Director, Center for Health Statistics

Professor of Biostatistics and Psychiatry

University of Illinois at Chicago

 

Discussion Questions:

 

  • What are the limitations of meta-analysis of RCT suicidality outcomes and how can they be solved?

  • Are there other approaches to looking at rare adverse events that should replace or augment the traditional approaches?

  • How do we insulate ourselves from bias?

    1. Ascertainment bias

    2. Regression toward the mean

    3. Natural course of the disease

    4. Confounding by indication

  • What data should be used in screening new drugs for rare AEs?

    1. New sources of spontaneous reports

    2. Medical claims databases

    3. Large practice studies

    4. Linkage to NVDRS

  • How can we determine if suicidal ideation is a valid predictor of suicide behavior and completion?

2:35 p.m.

BREAK

SESSION III:
PARTNERSHIPS: OPPORTUNITIES FOR COLLABORATION

Session Objective: Examine potential partnerships among the FDA, pharmaceutical industry, academia, and the NIH that could be used to facilitate data sharing from randomized clinical trials. Specifically, discuss optimal methods for collection of data by stakeholders in a common fashion and how best to share the data.

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

2:50 p.m.

Introduction to the Session

 

HUSSEINI MANJI, Session Co-chair

Global Head, Neuroscience

Johnson & Johnson Pharmaceutical Research and Development, LLC

 

DAVID MICHELSON, Session Co-chair

Vice President, Clinical Neuroscience

Merck Research Laboratories

Merck & Co., Inc.

3:00 p.m.

Panel Discussion: Current and Future Partnership Needs (Each presentation approximately 15 minutes)

 

What Core Elements Should Be Included in Data Collection?

 

MADHUKAR H. TRIVEDI

Chair in Mental Health

Professor of Psychiatry

University of Texas Southwestern Medical Center at Dallas

 

Ways to Facilitate Collaborations: How and Who?

 

SHAAVHRÉE BUCKMAN

Acting Director, Office of Translational Sciences

Center for Drug Evaluation and Research

Food and Drug Administration

 

Are There Ways to Create Robust and Informative Datasets Through Pooling?

 

CHARLES BEASLEY

Chief Scientific Officer, Global Patient Safety

Lilly Research Laboratories

Eli Lilly and Company

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

3:45 p.m.

Moderated Discussion with Attendees

 

HUSSEINI MANJI, Session Co-chair

Global Head, Neuroscience

Johnson & Johnson Pharmaceutical Research and Development, LLC

 

DAVID MICHELSON, Session Co-chair

Vice President, Clinical Neuroscience

Merck Research Laboratories

Merck & Co., Inc.

Discussion Questions:

 

  • How can the FDA work with academic institutions, the NIH, and/or industry to provide better surveillance?

  • How can all stakeholders conducting relevant clinical trials collect the needed information in a standard format?

  • What is the most efficient way to share data across trials?

SESSION IV:
FUTURE DIRECTIONS: DISCUSSION WITH WORKSHOP PARTICIPANTS AND ATTENDEES

Session Objective: Given the opportunities and constraints that exist to implementing the frameworks, methods, and partnerships discussed during the workshop, what resources are necessary to ensure that the most efficient and effective frameworks are in place for analysis of suicidality? What new ideas have surf aced in this meeting today that should be explored further?

4:30 p.m.

Summary Remarks

 

WILLIAM POTTER, Workshop Co-chair

Vice President, Clinical Neuroscience

Merck Research Laboratories

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

 

ROBERT GIBBONS, Workshop Co-chair

Director, Center for Health Statistics

Professor of Biostatistics and Psychiatry

University of Illinois at Chicago

4:50 p.m.

Open Discussion with Attendees

5:10 p.m.

ADJOURN

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

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

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