Meeting Videos

Sharing Clinical Research Data: A Workshop

Session IV: Q&A (20:04 )

Panelists answer questions from the audience members.

Sessions

  • Session III: Panel Q&A Panelists
    Institute of Medicine

    Panelists answer questions from the audience members.

  • Session V: Q&A Panelists
    Institute of Medicine

    Panelists answer questions from the audience members.

  • Adjourn Sharon Terry
    President and Chief Executive Officer, Genetic Alliance

    Closing remarks of the workshop

Adjourn
Sharon Terry
President and Chief Executive Officer, Genetic Alliance

Closing remarks of the workshop

Keynote Case Study: Distributed Systems for Clinical...
Richard Platt
Harvard Medical School

Keynote Presentation

Keynote Case Study: Distributed Systems for Clinical...
Richard Platt
Harvard Medical School

Richard Platt answers questions from the audience.

Opening Remarks
Sharon Terry, Workshop Chair
President and Chief Executive Officer, Genetic Alliance

The workshop's chair, Sharon Terry welcomes participants and introduces Panel I.

Opening Remarks
Sharon Terry
President and Chief Executive Officer, Genetic Alliance

Day 2 Introduction

Series of Brief Presentations on Overcoming Challenges...
Jennifer Geetter
McDermott Will & Emery

Challenge #1: Permissions

Series of Brief Presentations on Overcoming Challenges...
John Ioannidis
Stanford University

Challenge #2: Techniques and Methodologies [via video conference]

Series of Brief Presentations on Overcoming Challenges...
Kelly Edwards
University of Washington

Challenge #3: Culture

Session I: Benefits of Sharing Clinical Research Data
Elizabeth Loder
Clinical Epidemiology Editor, British Medical Journal

Fundamentals and Benefits of Sharing Participant-Level Clinical Trial Data

Session I: Benefits of Sharing Clinical Research Data
William Potter
FNIH Biomarkers Consortium

Brief introduction of panel participants before Panel Discussion

Session I: Benefits of Sharing Clinical Research Data
Deborah Zarin, Workshop Co-Chair
Director, ClinicalTrials.gov

Background and Session Objectives

Session I: Benefits of Sharing Clinical Research Data
Robert Califf
Director, Duke Translational Medicine Institute

Pooling Data from Multiple Clinical Trials to Answer Big Questions

Session I: Panel Discussion - Perspectives on the Benefits...
Jesse Berlin
Janssen Research and Development, LLC

1) Data sharing – what does it mean from your perspective? 2) Considering the benefits...

Session I: Panel Discussion - Perspectives on the Benefits...
Myles Axton
Nature Genetics

1) Data sharing – what does it mean from your perspective? 2) Considering the benefits...

Session I: Panel Discussion - Perspectives on the Benefits...
Harlab Krumholz
Yale University School of Medicine

1) Data sharing – what does it mean from your perspective? 2) Considering the benefits...

Session I: Q&A
Session I Panelists
Institute of Medicine

Panelists answer questions from audience participants

Session II: Data Sharing Models: Design, Best Practices,...
Richard Kuntz
Medtronic, Inc.

Models that Increase Access and Use of Data from Individual Clinical Trials/...

Session II: Data Sharing Models: Design, Best Practices,...
Jeffrey Nye, Session Chair
Janssen Research and Development, LLC

Background and Session Objectives

Session II: Data Sharing Models: Design, Best Practices,...
Charles Hugh-Jones
Medical Affairs North America

Models that Increase Access and Use of Data from Individual Clinical Trials/ The...

Session II: Data Sharing Models: Design, Best Practices,...
Jonathan Rabinowitz
Ilan University

Novel Methods Leading to New Medications in Depression and Schizophrenia (NEWMEDS)...

Session II: Data Sharing Models: Design, Best Practices,...
John Wagner
Merk & Co., Inc.

Models that Foster Pooling and Analysis of Data/ FNIH Biomarkers Consortium Adiponectin...

Session II: Data Sharing Models: Design, Best Practices,...
Deborah Zarin
ClinicalTrials.gov, NIH

The Limits of Summary Data Reporting: Lessons from ClinicalTrials.gov

Session II: Discussion among speakers, panelists, and...
Sally Okun
PatientsLikeMe

Discussion among speakers, panelists, and audience

Session II: Q&A
Panelists
Institute of Medicine

Panelists answer questions from the audience members.

Session III: Panel Discussion
Laura Lyman Rodriguez
Director, Office of Policy, Communications and Education, National Human Genome ...

Panelist presentation

Session III: Panel Discussion
Michael Cantor
Senior Director, Clinical Informatics and Innovation, Pfizer Inc.

Panelist presentation

Session III: Panel Discussion
Neil de Crescenzo
Senior Vice President and General Manager, Oracle Health Services

Panelist presentation

Session III: Panel Discussion
Meredith Nahm
Associate Director for Clinical Research Informatics, Duke Translational...

Panelist presentation

Session III: Panel Q&A
Panelists
Institute of Medicine

Panelists answer questions from the audience members.

Session III: Q&A
Panelists
Institute of Medicine

Panelists answer questions from the audience members.

Session III: Q&A
Panelists
Institute of Medicine

Panelists answer questions from the audience members.

Session III: Standarization and Governance
Ron Fitzmartin
U.S. Food and Drug Administration

PDUFA Update on Data Standards

Session III: Standarization and Governance
Lynn Hudson
Critical Path Institute

Background and Session Objectives by Frank Rockhold, Session Co-Chair and Lynn Hudson,...

Session III: Standarization and Governance
Vicki Seyfert-Margolis
Senior Advisor, Science Innovation and Policy, Office of the Chief Scientist,...

Cost-Benefit Analysis of Retrospective vs. Prospective Data Standardization

Session III: Standarization and Governance: Case Studies:...
Carolyn Compton
President and CEO, Critical Path Institute

Critical Path Institute and Coalition Against Major Diseases (CAMD) Alzheimer’s Clinical...

Session III: Standarization and Governance: Case Studies:...
Eric Perakslis
Chief Information Officer and Chief Scientist, Informatics, U.S. Food and Drug...

Translational Medicine Mart (tranSMART)

Session III: Standarization and Governance: Standardization ...
Rebecca Kush
Clinical Data Interchange Standards Consortium

CDISC Efforts to Support Clinical Research Data

Session III: Standarization and Governance: Standardization ...
Sachin Jain
Chief Medical Information and Innovation Officer, Merck & Co., Inc.

Health Information Technology Perspective on Clinical Research Data Standards

Session III: Standarization and Governance: Standardization ...
Charles Jaffe
Chief Executive Officer, Health Level 7 International

HL7 Efforts to Support Clinical Care Data

Session IV: Incentivizing Policy and Cultural Shifts to...
Deven McGraw
Director, Health Privacy Project, Center for Democracy and Technology

Facilitating Patient Ownership of Clinical Trial Data: Technical Challenges and...

Session IV: Incentivizing Policy and Cultural Shifts to...
Josephine Briggs
Director, National Center for Complementary and Alternative Medicine; Director, ...

Federal Research Funder Perspective

Session IV: Incentivizing Policy and Cultural Shifts to...
John Wilbanks
Director, Sage Bionetworks

Facilitating Patient Ownership of Clinical Trial Data: Technical Challenges and...

Session IV: Incentivizing Policy and Cultural Shifts to...
Hans-Georg Eichler
Senior Medical Officer, European Medicines Agency

Clinical Trial Data Transparency: European Medicines Agency Perspective

Session IV: Incentivizing Policy and Cultural Shifts to...
Robert Harrington
Arthur L. Bloomfield Professor of Medicine; Chair, Department of Medicine,...

Background and Session Objectives

Session IV: Incentivizing Policy and Cultural Shifts to...
Andrew Vickers
Attending Research Methodologist, Department of Epidemiology and Biostatistics, ...

Clinical Research Data Sharing Practices and Attitudes

Session IV: Incentivizing Policy and Cultural Shifts to...
Steven Goodman
Associate Dean for Clinical and Translational Research; Professor of Medicine & ...

Overview of Data Sharing Policies: Research Funders and Publishers

Session IV: Incentivizing Policy and Cultural Shifts to...
Beth Kozel
Instructor of Pediatrics, Division of Genetics and Genomic Medicine, St. Louis...

Academic Perspectives

Session IV: Incentivizing Policy and Cultural Shifts to...
Peter Doshi
Post-Doctoral Fellow, Johns Hopkins University School of Medicine

Academic Perspectives

Session IV: Q&A
Panelists
Institute of Medicine

Panelists answer questions from the audience members.

Session IV: Q&A
Panelists
Institute of Medicine

Panelists answer questions from the audience members.

Session V: Next Steps and Future Directions
Janet Woodcock
Director, Center for Drug Evaluation and Research, U.S. Food and Drug...

Closing Discussion with Session Chairs, Panelists, and Audience Led by Workshop Chair

Session V: Next Steps and Future Directions
Jay "Marty" Tenenbaum
Founder and Chairman, Cancer Commons

Closing Discussion with Session Chairs, Panelists, and Audience Led by Workshop Chair

Session V: Next Steps and Future Directions
Jeffrey Nye
Vice President and Head, Neuroscience External Innovation, Janssen Research and ...

Session II Chair Report

Session V: Next Steps and Future Directions
Michael Rosenblatt
Executive Vice President and Chief Medical Officer, Merck and Co., Inc.

Closing Discussion with Session Chairs, Panelists, and Audience Led by Workshop Chair

Session V: Next Steps and Future Directions
Josephine Briggs
Director, National Center for Complementary and Alternative Medicine; Director, ...

Closing Discussion with Session Chairs, Panelists, and Audience Led by Workshop Chair

Session V: Next Steps and Future Directions
Michael Rosenblatt
Executive Vice President and Chief Medical Officer, Merck & Co., Inc.

Session Chair Reports

Session V: Next Steps and Future Directions
Deborah Zarin
Director, ClinicalTrials.gov, National Library of Medicine, National Institutes ...

Session I Chair Reports

Session V: Next Steps and Future Directions
Robert Harrington
Arthur L. Bloomfield Professor of Medicine; Chair, Department of Medicine,...

Session IV Chair Report

Session V: Next Steps and Future Directions
Frank Rockhold
Senior Vice President, Global Clinical Safety and Pharmacovigilance,...

Session III Chair Report

Session V: Q&A
Panelists
Institute of Medicine

Panelists answer questions from the audience members.

Study Staff

  • Rebecca English, Study Director

Activity Contact Information

For More Information Contact

Board on Health Sciences Policy
Phone:
202-334-2914
Fax:
202-334-1329
E-mail:
Sharing_Clinical_Research_Data_Workshop@nas.edu

Mailing Address


Keck Center
500 Fifth St. NW
Washington, DC 20001

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