Aligning Incentives for Sharing Clinical Trial Data

April 3-4, 2017 | #NEJMDataSummit




Monday, April 3 | 8:30 am — 3:00 pm (ET)

8:30AM (ET)

Welcome and Opening Remarks and Behind the Curtain: Gathering and Preparing SPRINT Trial Data

Craig Baskin

SPRINT Trial Participant

Sean Coady

Statistician, National Heart, Lung, and Blood Institute (NHLBI)

Jeffrey M. Drazen, Summit Co-Chair

Editor-in-Chief, The New England Journal of Medicine

David Reboussin

Principal Investigator, Data Coordinating Center of SPRINT; Professor, Biostatistical Sciences, Wake Forest University

Brian Strom

Inaugural Chancellor of Rutgers Biomedical and Health Sciences, Executive Vice President for Health Affairs, Rutgers University

Daniel Weiner

Principal Investigator, Boston SPRINT site; Associate Professor of Medicine, Tufts University

10:15AM (ET)

Is the Juice Worth the Squeeze?

The Summit Co-Chairs moderate panel discussions that weigh the effort and value of sharing clinical trial data. Each panel discusses a core theme and features viewpoints from the three key constituencies in data sharing: clinical trialists, data analysts, and patient representatives.

Panel 1: Reproducibility of Findings

Panelists address the core issues of whether clinical trial analyses are reproducible and robust. If they differ, do the differences matter? How should conflicting findings be adjusted?

Paul Costello

SPRINT Trial Participant

PJ Devereaux

Professor, Department of Health Research Methods, Evidence, and Impact, McMaster University

Marc Pfeffer, Summit Co-Chair

Dzau Professor of Medicine, Harvard Medical School

Nigam Shah

Associate Professor of Medicine Biomedical Informatics, Stanford University

Janet Wittes

President, Statistics Collaborative

Panel 2: Beyond Reproducibility of Findings

Panelists discuss the value of further analyses beyond those already addressed by the trial. How to make good and reliable use of others' data? What is the value of the data for trialists, analysts, the public?

Atul Butte

Director of the Institute of Computational Health Sciences, University of California, San Francisco

Rory Collins

Professor of Medicine and Epidemiology, University of Oxford

Isaac Kohane, Summit Co-Chair

Marion V. Nelson Professor of Biomedical Informatics, Harvard Medical School

Sharon Terry

CEO, Genetic Alliance

Panel 3: Aligning Academic Rewards that Work

Clinical trials require effort to accrue and organize data. How do we ensure all involved are adequately recognized and rewarded in a way that retains societal and academic incentives?

Salim Abdool Karim

CAPRISA Professor of Global Health in Epidemiology, Columbia University

Daniel MacArthur

Assistant Professor, Harvard Medical School and Massachusetts General Hospital

John McMurray

Professor of Cardiology, University of Glasgow

Matthew Might, Summit Co-Chair

Department of Biomedical Informatics, Harvard Medical School

Heather Pierce

Senior Director, Science Policy and Regulatory Counsel, Association of American Medical Colleges

1:45PM (ET)

SPRINT Data Analysis Challenge and Winners Present

Insights are shared from the SPRINT Data Analysis Challenge, a practical example of data sharing in today's environment. The SPRINT Challenge winners discuss their novel finding and earn international bragging rights.

Rahul Aggarwal, Second Place Winner in the SPRINT Challenge

Boston University School of Medicine

Ran Balicer, On Behalf of Noa Dagan

Director, Clalit Research Institute

Sanjay Basu, Third Place Winner in the SPRINT Challenge

Stanford University

Noa Dagan, First Place Winner in the SPRINT Challenge

Chief Data Officer and Researcher, Clalit Reseach Institute

Pam Miller

SPRINT Data Analysis Challenge Coordinator, The New England Journal of Medicine



Tuesday, April 4 | 8:30 am — 12:00 pm (ET)

8:30AM (ET)

Day 2 Welcome and Panel 1: Repositories: Keepers of Data

Barbara Bierer

Professor of Medicine, Harvard Medical School

Ewan Birney

Director, European Bioinformatics Institute

Jeffrey M. Drazen, Summit Co-Chair

Editor-in-Chief, The New England Journal of Medicine

Margaret Levenstein

Director, ICPSR, The University of Michigan

Jennifer O’Callaghan

Clinical Data Sharing Manager, Wellcome Trust

8:30AM (ET)

Aligning Incentives: Repositories, Funders and Patients

To broaden the focus to incorporate other key constituencies who play a part in data sharing success, three panel discussions explore the issues from their respective points of view.

Panel 2: Funders: Sponsors of Data

Robert Califf

Professor of Medicine, Duke University

Robert Kiley

Open Research--Development Lead, Wellcome Trust

Michael Lauer

Deputy Director for Extramural Research, National Institutes of Health

Richard Wilder

Associate General Counsel, Gates Foundation

Panel 3: Patients: Sources of Data

Marcia Manong

Clinical Trial Participant

Matthew Might, Summit Co-Chair

Department of Biomedical Informatics, Harvard Medical School

Nancy Nagler

Clinical Trial Participant

Moses Taylor

SPRINT Trial Participant

10:50AM (ET)

Reports from the Problem-Solving Sessions: Live Event and Online Groups

Theme leaders report and discuss the key points raised in Monday's problem-solving working sessions. Panelists discuss their importance and participate in Q&A.

Esteban Burchard

Professor of Medicine, Bioengineering, and Therapeutic Sciences, University of California, San Francisco

Jeffrey M. Drazen, Summit Co-Chair

Editor-in-Chief, The New England Journal of Medicine

Gary H. Gibbons

Director, National Heart Lung and Blood Institute (NHLBI)

Bernard Lo

President, Greenwall Foundation

11:45AM (ET)

Lessons Learned From Listening and Next Steps

Jeffrey M. Drazen, Summit Co-Chair

Editor-in-Chief, The New England Journal of Medicine