Steering Committee Meeting
April 14-15, 2021
Virtual
Main Purpose
To discuss important considerations for Collaboratory trials and the embedded pragmatic clinical trial ecosystem at large, including adaptations made due to COVID-19, data sharing models and experiences, barriers encountered, and lessons learned.
- View the agenda (PDF)
- View the participant list (PDF)
Wednesday, April 14, 2021
Welcome and Opening Remarks
Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD
Discussion of learnings from the RECOVERY platform and implications for embedded PCTs
Martin Landray, PhD
High-Level Overview: Impact of COVID-19 on Collaboratory Projects
Discussion of the overarching impacts of COVID-19 on the NIH Collaboratory Trials and support provided by the Coordinating Center
Emily O'Brien, PhD
Barriers, Challenges, and Opportunities Encountered From COVID-19 and Lessons Learned from the UH3s
Changes in Study Design and Analysis
Moderated discussion about adaptations to design, measurement, and analysis due to COVID-19
Moderator: Liz Turner, PhD
Panel:
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- ACP PEACE: James Tulsky, MD; Angelo Volandes, MD, MPH
- PRIM-ER: Corita Grudzen, MD, MSHS
- HiLo: Myles Wolf, MD
Moderated discussion about transitions to virtual engagement and the impact on trials and research staffing due to COVID-19
Moderators: Eric Larson, MD; Rachel Richesson, PhD
Panel:
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- GGC4H: Margaret Kuklinski, PhD; Stacy Sterling, DrPH, MSW
- OPTIMUM: Natalia Morone, MD
- Nudge: Michael Ho, MD, PhD
- BackInAction: Karen Sherman, PhD, MPH; Lynn DeBar, PhD, MPH
- FM-TIPS: Kathleen Sluka, PT, PhD; Leslie Crofford, MD
- EMBED: Ted Melnick, MD, MHS; Gail D’Onofrio, MD, MS
- NOHARM: Andrea Cheville, MD; Jon Tilburt, MD
Reengineering Pragmatic Research for Future Pandemics
Discussion of how COVID-19 will impact research taking place during future pandemics
Adrian Hernandez, MD, MHS
Closing Remarks
Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD
Thursday, April 15, 2021
Welcome and Opening Remarks
Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD
Discussion From the UG3 NIH Collaboratory Trials
Update on the status of the UG3 efforts, transition issues, lessons learned, sustainability for the UH3 phase, and challenges
- BeatPain Utah: Julie Fritz, PhD, PT
- GRACE: Ardith Z. Doorenbos, PhD, RN; Robert E. Molokie, MD; Judith M. Schlaeger, PhD; Miriam O. Ezenwa, PhD, RN; Nirmish Shah, MD
Data Sharing and the Privacy and Consent Implications for Collaboratory
Discussion of privacy and consent issues that influence data sharing, including impacts on the NIH Collaboratory and HEAL projects
- Wendy Weber, ND, PhD, MPH
- Kayte Spector-Bagdady, JD, MBe
Data Sharing Requirements for NIH ClinicalTrials.gov and PRISM Collaboratory
Review of current data sharing policies for HCS Collaboratory and PRISM Collaboratory (under the HEAL Initiative) and discussion of the differences between the policies
- Adrian Hernandez, MD, MHS
- Jessica Mazerik, PhD
Closing Remarks
Helene Langevin, MD, PhD; Richard Hodes, MD; Kevin Weinfurt, PhD
NIH-Hosted Workshop: Inclusion of Diverse Participants in Pragmatic Clinical Trials
This 6-part workshop series held from May to August 2021 focuses on the inclusion of diverse participants in pragmatic clinical trials with insights about planning for diversity, engaging participants, learning from implementation science to maximize diversity, and developing a pipeline of diverse investigators. View all 6 parts of the Inclusion of Diverse Participants in Pragmatic Clinical Trials workshop series.