April 2015 Steering Committee Meeting

Steering Committee Meeting

April 20-21, 2015
Bethesda, MD

Main Purpose

To celebrate the progress of the Collaboratory, hear updates from the Core Working Groups and Committees, plan for the implementation phase for the Multiple Chronic Conditions UH2s, hear updates and lessons learned from the UH3s, and discuss sustainability of the Collaboratory and the generalizable knowledge learned over these 3 years.

 

Monday, April 20, 2015

Welcome and Opening Remarks
Barry Coller, MD, Josephine Briggs, MD, and Lesley Curtis, PhD

PCORnet Update (PDF)
Rachael Fleurence, PhD

DRN Network Querying Capabilities/Investigator and NIH Initiative Use of the DRN (PDF)
Lesley Curtis, PhD, and Jeffrey Brown, PhD

Panel Discussion With Core Groups (PDF)
Moderator: Kevin Weinfurt, PhD

  • Biostatistics and Study Design
    Liz DeLong, PhD

Panel Discussion With Core Groups
Moderator: Adrian Hernandez, MD, MHS

  • Stakeholder Engagement
    Sean Tunis, PhD, MSc

Discussion of Regulatory/Ethics Core Work Group Manuscripts
Moderators: Jeremy Sugarman, MD, PhD, and Kevin Weinfurt, PhD

  • Privacy Paper and Q&A
    Deven McGraw, JD, MPH, LLM

  • Minimal Risk Paper and Q&A
    John Lantos, MD

Panel Discussion From the NIH Bioethics Supplements
Moderator: Wendy Weber, MD, PhD, MPH
Jeremy Sugarman, PhD, MPH, Kevin Weinfurt, PhD, Susan Huang, MD, and Laura Dember, MD

IRB of Record (PDF)
Petra Kaufmann, MD, MSc

Breakout Sessions
Concurrent group discussions on several topics: biostatistics, regulatory/ethics, communication dissemination, data sharing, lessons learned, and project best practices

Closing Remarks
Barry Coller, MD, Josephine Briggs, MD, and Lesley Curtis, PhD

Reception

Tuesday, April 21, 2015

Welcome and Opening Remarks
Barry Coller, MD, Josephine Briggs, MD, and Lesley Curtis, PhD

Updates From the Multiple Chronic Conditions (MCC) UH2 NIH Collaboratory Trials

Promoting Diversity in Health-Related Research (PDF)
Monique Anderson, MD

Lessons Learned From UH3 NIH Collaboratory Trials

The Living Textbook (PDF)
Jonathan McCall, MS

Compilation and Review of Milestones From the Collaboratory and Sustainability of the Collaboratory (PDF)
Adrian Hernandez, MD, MHS

Closing Remarks
Barry Coller, MD, Josephine Briggs, MD, and Lesley Curtis, PhD

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 Meyers, 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, and 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 Meyers, 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 Vazquez, MD

Panel 4: Vulnerable Populations
Moderator: David Wendler, PhD

  • Susan 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