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Appendix A: Workshop Agenda
Pages 85-100

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From page 85... ... This workshop will explore the benefits of and barriers to the sharing of clinical research data and will help identify strategies for enhancing the sharing both within and across sectors. To facilitate identification of key issues and potential solutions, the workshop will focus on data resulting from preplanned interventional studies of human subjects. Read the entire page →
From page 86... ... The workshop is being jointly organized by the Institute of Medicine's Forum on Drug Discovery, Development, and Translation; Forum on Neuroscience and Nervous System Disorders; National Cancer Policy Forum; and Roundtable on Translating Genomic-Based Research for Health. Meeting Objectives:  Examine the benefits of sharing of clinical research data, and specifically clinical trial data, from all sectors and among these sectors, including, for example: o Benefits to the research and development enterprise o Benefits to the analysis of safety and efficacy  Identify barriers and challenges to sharing clinical research data. Read the entire page →
From page 87... ... Biomarkers Consortium DEBORAH ZARIN, Session Co-Chair Director, ClinicalTrials.gov National Library of Medicine National Institutes of Health 8:50 a.m. Fundamentals and Benefits of Sharing Participant Level Clinical Trial Data ELIZABETH LODER Clinical Epidemiology Editor, BMJ 9:10 a.m. Read the entire page →
From page 88... ... Hines, Jr., Professor of Medicine and Epidemiology and Public Health Yale University School of Medicine MYLES AXTON Editor Nature Genetics JESSE BERLIN Vice President of Epidemiology Janssen Research & Development, LLC Panel Moderators WILLIAM POTTER, Session Co-Chair Co-Chair Emeritus Neuroscience Steering Committee FNIH Biomarkers Consortium DEBORAH ZARIN, Session Co-Chair Director, ClinicalTrials.gov National Library of Medicine National Institutes of Health 10:30 a.m. Read the entire page →
From page 89... ... The Limits of Summary Data Reporting: Lessons from ClinicalTrials.gov DEBORAH ZARIN Director, ClinicalTrials.gov National Library of Medicine National Institutes of Health 11:10 a.m. Models That Increase Access and Use of Data from Individual Clinical Trials The DataSphere Project CHARLES HUGH-JONES Vice President, Medical Affairs North America Sanofi Oncology, on behalf of the Life Sciences Consortium CEO Roundtable on Cancer Read the entire page →
From page 90... ... 11:40 a.m. Models That Foster Pooling and Analysis of Data FNIH Biomarkers Consortium Adiponectin Project JOHN WAGNER Vice President, Clinical Pharmacology Merck & Co., Inc. Read the entire page →
From page 91... ... LUNCH KEYNOTE CASE STUDY: DISTRIBUTED SYSTEMS FOR CLINICAL RESEARCH INFORMATION SHARING 1:30 p.m. RICHARD PLATT Professor and Chair Department of Population Medicine Harvard Pilgrim Health Care Institute and Harvard Medical School 1:50 p.m. Read the entire page →
From page 92... ... 2:00 p.m. Background and Session Objectives FRANK ROCKHOLD, Session Co-Chair Senior Vice President, Global Clinical Safety and Pharmacovigilance GlaxoSmithKline Pharmaceuticals Research and Development LYNN HUDSON, Session Co-Chair Chief Science Officer and Executive Director Coalition Against Major Diseases Critical Path Institute 2:10 p.m. Read the entire page →
From page 93... ... Prospective Data Standardization VICKI SEYFERT-MARGOLIS Senior Advisor, Science Innovation and Policy Office of the Chief Scientist U.S. Food and Drug Administration 4:00 p.m. Read the entire page →
From page 94... ... . Panelists LAURA LYMAN RODRIGUEZ Director Office of Policy, Communications and Education National Human Genome Research Institute MEREDITH NAHM Associate Director for Clinical Research Informatics Duke Translational Medicine Institute NEIL DE CRESCENZO Senior Vice President and General Manager Oracle Health Sciences Read the entire page →
From page 95... ... Adjourn Day One October 5, 2012 Day Two 8:00 a.m. Opening Remarks SHARON TERRY, Workshop Chair President and Chief Executive Officer Genetic Alliance SESSION IV: INCENTIVIZING POLICY AND CULTURAL SHIFTS TO ENHANCE DATA SHARING Session Objectives:  Receive an update on clinical trial data transparency decisions in Europe. Read the entire page →
From page 96... ... Clinical Research Data Sharing Practices and Attitudes ANDREW VICKERS Attending Research Methodologist Department of Epidemiology and Biostatistics Memorial Sloan-Kettering Cancer Center 8:55 a.m. Overview of Data-Sharing Policies: Research Funders and Publishers STEVEN GOODMAN Associate Dean for Clinical and Translational Research Professor of Medicine & Health Research and Policy Stanford University School of Medicine 9:10 a.m. Read the entire page →
From page 97... ... BREAK 10:45 a.m. Facilitating Patient Ownership of Clinical Trial Data: Technical Challenges and Opportunities JOHN WILBANKS Director Sage Bionetworks DEVEN MCGRAW Director, Health Privacy Project Center for Democracy and Technology 11:15 a.m. Read the entire page →
From page 98... ... Session Chair Reports (5 minutes per session) WILLIAM POTTER, Session I Co-Chair Co-Chair Emeritus Neuroscience Steering Committee FNIH Biomarkers Consortium DEBORAH ZARIN, Session I Co-Chair Director, ClinicalTrials.gov National Library of Medicine National Institutes of Health JEFFREY NYE, Session II Chair Vice President Neuroscience Innovation and Partnership Strategy Janssen Research & Development, LLC Read the entire page →
From page 99... ... Closing Discussion with Session Chairs, Panelists, and Audience Led by Workshop Chair JOSEPHINE BRIGGS Director, National Center for Complementary and Alternative Medicine Director, National Center for Advancing Translation Sciences, Division of Clinical Innovation National Institutes of Health MICHAEL ROSENBLATT Executive Vice President and Chief Medical Officer Merck & Co., Inc. JAY "MARTY" TENENBAUM Founder and Chair Cancer Commons JANET WOODCOCK Director, Center for Drug Evaluation and Research U.S. Read the entire page →

From page 85...

... This workshop will explore the benefits of and barriers to the sharing of clinical research data and will help identify strategies for enhancing the sharing both within and across sectors. To facilitate identification of key issues and potential solutions, the workshop will focus on data resulting from preplanned interventional studies of human subjects.

Appendix A: Workshop Agenda Pages 85-100

Appendix A: Workshop Agenda
Pages 85-100