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.



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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. 51

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52 CNS CLINICAL TRIALS: SUICIDALITY AND DATA COLLECTION • 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 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 Psychopharmacological Drug Advisory Committee

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APPENDIX B 53 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 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 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

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54 CNS CLINICAL TRIALS: SUICIDALITY AND DATA COLLECTION 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.

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APPENDIX B 55 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

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56 CNS CLINICAL TRIALS: SUICIDALITY AND DATA COLLECTION 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.

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APPENDIX B 57 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

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58 CNS CLINICAL TRIALS: SUICIDALITY AND DATA COLLECTION 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 sur- veillance? • 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

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APPENDIX B 59 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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