Steering Committee Meeting
May 9-10, 2016
Bethesda, MD
Main Purpose
Day 1: To celebrate the progress of the Collaboratory, hear updates from the Core Working Groups and Committees, hear updates and lessons learned from the UH3s, discuss data sharing, and discuss sustainability of the Collaboratory and the generalizable knowledge learned
Day 2: A workshop to inform research funders and investigators on progress in navigating the ethical and regulatory challenges of pragmatic clinical trials
Monday, May 9, 2016
Welcome and Opening Remarks
Catherine Myers, MD, and Lesley Curtis, PhD
Keynote Speaker
Michael Lauer, MD
Distributed Research Network (DRN) Querying: Use and Sustainability
Lesley Curtis, PhD, and Richard Platt, MD, MSc
Data Governance/Data Sharing: Principles and Policy
Adrian Hernandez, MD, MHS, and Gregory Simon, MD, MPH
Data Governance/Data Sharing
Moderator: Adrian Hernandez, MD, MHS
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Suicide Prevention Outreach Trial (SPOT)
Greg Simon, MD, MPH -
Active Bathing to Eliminate (ABATE) Infection Trial
Susan Huang, MD -
Lumbar Imaging with Reporting of Epidemiology (LIRE)
Jerry Jarvik, MD, MPH -
Time to Reduce Mortality in End-Stage Renal Disease (TiME)
Laura Dember, MD -
Collaborative Care for Chronic Pain in Primary Care (PPACT)
Lynn DeBar, PhD, MPH -
Strategies and Opportunities to Stop Colorectal Cancer (STOP CRC)
Gloria Coronado, PhD
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Trauma Survivors Outcomes and Support (TSOS)
Doug Zatzick, MD -
Pragmatic Trial of Video Education in Nursing Homes (PROVEN)
Vincent Mor, PhD -
Improving Chronic Disease Managment with Pieces (ICD-Pieces)
Miguel Vazquez, MD
ICD-10 Transition
Rachel Richesson, PhD, MPH
Unstable Control Groups
Liz DeLong, PhD, David Murray, PhD
Results Reporting for Pragmatic Clinical Trials
Kevin Weinfurt, PhD
Collaboratory Core Group Discussion
Training/Mentoring the Next Generation of Researchers
Adrian Hernandez, MD, MHS
Generalizable Lessons Learned and Sustainability from the Demonstration Projects
Living Textbook
Kevin Weinfurt, PhD
Closing Remarks
Lesley Curtis, PhD, and Catherine Myers, MD
Tuesday, May 10, 2016
Videocast of the Ethical and Regulatory Issues of Pragmatic Clinical Trials Workshop
Welcome and Opening Remarks
Catherine Myers, MD, and Wendy Weber, ND, PhD, MPH
Keynote Speaker
Jeremy Sugarman, MD, MPH
Panel 1: Options for Altered Consent and the Importance of Minimal Risk Determination
Moderator: Kevin Weinfurt, PhD
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Laura Dember, MD
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Gregory Simon, MD, MPH
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John Lantos, MD
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Emma Meagher, MD
Panel 2: Oversight of Pragmatic Clinical Trials: Institutional Review Boards and Data and Safety Monitoring Boards
Moderator: Adrian Hernandez, MD, MHS
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Douglas F. Zatzick, MD
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P. Pearl O'Rourke, MD
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Susan S. Ellenberg, PhD
Panel 3: Privacy Issues for Pragmatic Clinical Trials
Moderator: Valerie Bonham, JD
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Sarah M. Greene, MPH
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Valery Gordon, PhD, MPH
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Miguel Bazquez, MD
Panel 4: Vulnerable Populations
Moderator: David Wendler, PhD
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Susan S. Huang, MD
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Mary Jane Welch, DNP, APRN, BC
Panel 5: Expert Panel Q&A
Moderator: Jeremy Sugarman, MD, MPH
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Kevin Weinfurt, PhD
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Adrian Hernandez, MD, MHS
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Valerie Bonham, JD
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David Wendler, PhD
Concluding Remarks