May 2018 Steering Committee Meeting

Steering Committee Meeting

May 14-16, 2018
Bethesda, MD

Main Purpose

Day 1: Welcome the new UG3 Demonstration Projects; provide introductions, an overview of the Collaboratory, and an understanding of the Core Working Groups; and discuss lessons learned, data sharing, and current ethics and regulatory issues.

Day 2: Celebrate the Collaboratory's progress; kick off the next 5 years; receive updates from the Core Working Groups; and hear about the top barriers/challenges and lessons learned from the UH3s.

Day 3: Intensive workshop to start discussions on embedded A vs. B pragmatic clinical trials.

Monday, May 14, 2018

Welcome, Opening Remarks, and Introductions
David Shurtleff, PhD, Richard Hodes, MD, Lesley Curtis, PhD

Overview of a Cooperative Agreement
Wendy Weber, ND, PhD, MPH

Overview of the NIH HCS Research Collaboratory Program
David Shurtleff, PhD

Panel of Directors: Richard Hodes, MD, Wilson Compton, MD, David Murray, PhD, Bill Riley, PhD, Gary Gibbons, MD, Rob Star, MD

Collaboratory Coordinating Center Overview and Goals
Adrian Hernandez, MD, MHS

Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials
Jonathan McCall, MS

Policies and Guidance Documents

NIH Collaboratory Data Sharing Policy and Considerations
Adrian Hernandez, MD, MHS

Publications and Products Process
Eric Larson, MD, MPH

Data Quality
Rachel Richesson, PhD, MPH

New UG3 Demonstration Projects Updates
Brief overview of the projects

NIH and Other Requirements for Reporting
Deborah Zarin, MD

Results Reporting of ePCTs
Adrian Hernandez, MD, MHS

Distributed Research Network Query Capabilities 
Richard Platt, MD, Lesley Curtis, PhD

Closing Remarks
David Shurtleff, PhD, Richard Hodes, MD, Lesley Curtis, PhD 

Tuesday, May 15, 2018

Welcome and Opening Remarks
David Shurtleff, PhD, Richard Hodes, MD, Lesley Curtis, PhD

Landscape of National ePCT Initiative
Explanation of initiatives are promoting ePCTs and future directions

Health Systems Engagement Issues and Lessons Learned from the Health Care Systems Interactions Core
Eric Larson, MD, MPH

UH3 Demonstration Projects
Top barriers/challenges and recent generalizable lessons learned


Tuesday, May 15, 2018 (Continued)

Discussion from New UG3 Demonstration Projects
Overview of project and discussion

CMS Quality Measures
Reena Duseja, MD

Lessons Learned from Core Groups
Discussion on generalizable knowledge created out of the Cores, how it can be used, and future work of the Cores

Data Sharing Principles and Lessons Learned
Greg Simon, MD, MPH

Closing Remarks
David Shurtleff, PhD, Richard Hodes, MD, Lesley Curtis, PhD

Wednesday, May 16, 2018

Welcome and Introduction
David Shurtleff, PhD, Richard Hodes, MD, Catherine Meyers, MD, Wendy Weber, PhD, MPH

Panel Discussions

Panel 1: Partnering With Stakeholders to Conduct Embedded A vs. B Trials: Keys to Success Moderator: Rich Platt, MD, MSc

  • Steve Friedhoff, MD
  • Kenneth Sands, MD, MPH
  • Joseph Chin, MD

Panel 2: Examples in Action: Embedded A vs. B Trials Moderator: Beverly Green, MD, MPH

  • Ryan Ferguson, ScD, MPH
  • Susan Huang, MD, MPH
  • Michael Kappelman, MD, MPH

Panel 3: Maximizing the Pragmatic: Understanding Approaches to Design of Embedded A vs. B Trials Moderator: Greg Simon, MD, MPH

  • Scott Solomon, MD
  • Rachael Fleurence, PhD
  • Kourtney Davis, PhD, MSPH

Panel 4: Regulatory Aspects of Clinical Research and the Regulation of Products for Embedded A vs. B Pragmatic Trials Moderator: Adrian Hernandez 

  • Jacqueline Corrigan-Curay, MD, JD
  • Owen Faris, PhD
  • Julie Kaneshiro, MA

Panel 5: Ethical and IRB Approaches for a Successful Embedded A vs. B Pragmatic Trials Moderator: David Wendler, PhD

  • Barbara Bierer, MD
  • Spencer Hey, PhD
  • Judith Carrithers, JD, MPA

Summary Expert Panel Discussion Moderator: Cathy Meyers, MD

  • Adrian Hernandez, MD
  • Rich Platt, MD, MSc
  • Beverly Green, MD, MPH
  • Greg Simon, MD, MPH
  • Dave Wendler, PhD

Concluding Remarks 
Adrian Hernandez, MD, MHS, and Rich Platt, MD, MSc


May 2018 Steering Committee Meeting: May 2018 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 March 26, 2020.