CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary (2010)
Chapter: Appendix B: Workshop Agenda
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).
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Review available data on the extent to which emergent suicidal ideation predicts the occurrence of actual suicidal behavior, particularly in the short term.
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Ascertain optimal methods of analysis to address if suicidal ideation predicts the short-term occurrence of actual suicidal behavior.
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Examine potential partnerships among the FDA, pharmaceutical industry, academia, and the NIH that could be used to facilitate data sharing from randomized clinical trials.
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9:00 a.m. |
Welcome, Introductions, and Workshop Objectives |
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WILLIAM POTTER, Workshop Co-chair Vice President Clinical Neuroscience Merck Research Laboratories Merck & Co., Inc. |
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ROBERT GIBBONS, Workshop Co-chair Director, Center for Health Statistics Professor of Biostatistics and Psychiatry University of Illinois at Chicago |
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9:15 a.m. |
FDA Policies and Perspectives: Suicidality Studies in IND |
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THOMAS LAUGHREN Director Division of Psychiatry Products Food and Drug Administration |
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9:35 a.m. |
C-CASA and C-SSRS in CN S Clinical Trials: Development and Implementation |
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KELLY POSNER Director Center for Suicide Risk Assessment New York State Psychiatric Institute |
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9:55 a.m. |
Perspectives from the Patient Community |
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GAIL GRIFFITH Consumer Representative Food and Drug Administration’s Psychopharmacological 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 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.
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10:10 a.m. |
Introduction to the Session |
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DAVID BRENT, Session Chair Professor Department of Psychiatry University of Pittsburgh School of Medicine |
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10:15 a.m. |
Panel Discussion: Assessing the Risk Between Ideation and Action (Each presentation approximately 15 minutes) |
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Frequency with Which Suicide (or Serious Attempts) Is Preceded by Expressed Ideation: A Literature Review |
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MATTHEW NOCK Associate Professor of Social Sciences Department of Psychology Harvard University |
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Measurement of Suicide Ideation |
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GREGORY BROWN Research Associate Professor of Clinical Psychology in Psychiatry Department of Psychiatry University of Pennsylvania |
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Treatment Emergent Suicidal Events in Adolescents: Neurobiology and Clinical Significance |
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J. JOHN MANN Professor of Translational Neuroscience, Psychiatry, and Radiology Columbia University Chief, Department of Neuroscience New York State Psychiatric Institute |
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11:00 a.m. |
Moderated Discussion with Attendees |
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DAVID BRENT, Session Chair Professor Department of Psychiatry University of Pittsburgh School of Medicine |
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Discussion Questions: |
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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.
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12:45 p.m. |
Introduction to the Session |
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ROBERT GIBBONS, Session Chair Director, Center for Health Statistics Professor of Biostatistics and Psychiatry University of Illinois at Chicago |
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12:50 p.m. |
Panel Discussion: Data Analysis Strategies (Each presentation approximately 15 minutes) |
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Potential Drawbacks in Existing Methodologies |
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JOEL GREENHOUSE Professor Department of Statistics Carnegie Mellon University |
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Design and Analytic Strategies for Modeling Suicidality |
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ROBERT GIBBONS Director, Center for Health Statistics Professor of Biostatistics and Psychiatry University of Illinois at Chicago |
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Design and Analytic Strategies for Modeling Suicidality: An FDA Perspective |
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MARC STONE Senior Medical Reviewer Division of Psychiatry Products Food and Drug Administration |
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Studying Suicidality: From RCTs to OCER |
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ROBERT VALUCK Professor Department of Clinical Pharmacy University of Colorado at Denver |
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1:50 p.m. |
Moderated Discussion with Attendees |
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ROBERT GIBBONS, Session Chair Director, Center for Health Statistics Professor of Biostatistics and Psychiatry University of Illinois at Chicago |
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Discussion Questions: |
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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.
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2:50 p.m. |
Introduction to the Session |
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HUSSEINI MANJI, Session Co-chair Global Head, Neuroscience Johnson & Johnson Pharmaceutical Research and Development, LLC |
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DAVID MICHELSON, Session Co-chair Vice President, Clinical Neuroscience Merck Research Laboratories Merck & Co., Inc. |
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3:00 p.m. |
Panel Discussion: Current and Future Partnership Needs (Each presentation approximately 15 minutes) |
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What Core Elements Should Be Included in Data Collection? |
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MADHUKAR H. TRIVEDI Chair in Mental Health Professor of Psychiatry University of Texas Southwestern Medical Center at Dallas |
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Ways to Facilitate Collaborations: How and Who? |
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SHAAVHRÉE BUCKMAN Acting Director, Office of Translational Sciences Center for Drug Evaluation and Research Food and Drug Administration |
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Are There Ways to Create Robust and Informative Datasets Through Pooling? |
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CHARLES BEASLEY Chief Scientific Officer, Global Patient Safety Lilly Research Laboratories Eli Lilly and Company |
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3:45 p.m. |
Moderated Discussion with Attendees |
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HUSSEINI MANJI, Session Co-chair Global Head, Neuroscience Johnson & Johnson Pharmaceutical Research and Development, LLC |
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DAVID MICHELSON, Session Co-chair Vice President, Clinical Neuroscience Merck Research Laboratories Merck & Co., Inc. |
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Discussion Questions: |
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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?
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4:30 p.m. |
Summary Remarks |
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WILLIAM POTTER, Workshop Co-chair Vice President, Clinical Neuroscience Merck Research Laboratories |
