Meeting Agenda

Agenda: Workshop on CNS Clinical Trials: Suicidality and Data Collection

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 CNS 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 Psychopharmalogical Drug Advisory Committee

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 4-16 weeks). 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 Medical Center

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

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 Medical Center 

Discussion Questions:

·   Do the SSRS measure what it says it measures?
·   Are there outcomes that should be assessed but are not?
·   Under what conditions (type of interview, spontaneous vs. systematic) would optimize assessment?
·   What are the public health implications of the events detected by the SSRS?

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. 

12:45 p.m.         Introduction to the Session

Robert Gibbons, Session Chair
Professor of Biostatistics and Psychiatry 
Center for Health Statistics
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
Professor of Biostatistics and Psychiatry 
Center for Health Statistics
University of Illinois at Chicago

Design and Analytic Strategies for Modeling Suicidality: An FDA perspective

Marc Stone
Senior Medical Reviewer
Division of Neurology Products 
Food and Drug Administration

Studying Suicidality: From RCTs to OCER

Robert Valuck
Professor
Department of Clinical Pharmacy
University of Colorado, Denver

1:50 p.m.           Moderated Discussion with attendees

Robert Gibbons, Session Chair
Professor of Biostatistics and Psychiatry
Center for Health Statistics
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?
        a) ascertainment bias
        b) regression towards the mean
        c) natural course of the disease
        d) confounding by indication
·   What data should be used in screening new drugs for rare AEs?
        a) new sources of spontaneous reports
        b) medical claims databases
        c) large practice studies
        d) 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 between 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.

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 School 

Ways to facilitate collaborations: How and who?

ShaAvhree 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

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 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 surfaced 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 
Merck & Co., Inc.

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

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