May 2016 Steering Committee Meeting

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

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

  • Laura Dember, MD

  • Gregory Simon, MD, MPH

  • John Lantos, MD

  • Emma Meagher, MD

Panel 2: Oversight of Pragmatic Clinical Trials: Institutional Review Boards and Data and Safety Monitoring Boards
Moderator: Adrian Hernandez, MD, MHS

  • Douglas F. Zatzick, MD

  • P. Pearl O'Rourke, MD

  • Susan S. Ellenberg, PhD

Panel 3: Privacy Issues for Pragmatic Clinical Trials
Moderator: Valerie Bonham, JD

  • Sarah M. Greene, MPH

  • Valery Gordon, PhD, MPH

  • Miguel Bazquez, MD

Panel 4: Vulnerable Populations
Moderator: David Wendler, PhD

  • Susan S. Huang, MD

  • Mary Jane Welch, DNP, APRN, BC

Panel 5: Expert Panel Q&A
Moderator: Jeremy Sugarman, MD, MPH

  • Kevin Weinfurt, PhD

  • Adrian Hernandez, MD, MHS

  • Valerie Bonham, JD

  • David Wendler, PhD

Concluding Remarks


May 2016 Steering Committee Meeting: May 2016 Steering Committee Meeting. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: Updated June 6, 2019.