Steering Committee Meeting
May 16-17, 2023
Bethesda, MD
Main Purpose
To discuss important considerations for Collaboratory trials and the embedded pragmatic clinical trial ecosystem at large, including implementation science in the context of pragmatic trials, data sharing models and experiences, barriers encountered, and lessons learned.
Tuesday, May 16, 2023
Welcome and Opening Remarks
Helene Langevin, MD, PhD; Lesley Curtis, PhD
Keynote Panel-Implementation Science
Discussion of the role of implementation science in ePCTs.
David Chambers, DPhil
Focus on Implementation Science: Insights From Trials
Hear from the NIH Collaboratory Trials about intervention implementation/delivery challenges. Discuss pitfalls and barriers in the delivery of the intervention. Understand how the Implementation Science Core can help mitigate some of the challenges and facilitate next steps.
Moderator: Devon Check, PhD
Panel:
- Hayden Bosworth, PhD
- Lynn DeBarr, PhD, MPH (PPACT)
- Vince Mor, PhD (PROVEN)
Focus on Implementation Science: Intervention Delivery Complexity and the Collaboratory Tool
Introduce the intervention complexity tool. Understand how intervention complexity can impact the ability to get results. Identify what can be done differently to reduce complexity and the next steps in tool development. Hear from Projects (ACP COVID and PROVEN) that have used the tool and lessons learned.
Moderator: Steven George, PT, PhD
Speaker: Lindsay Ballengee
Panel:
- Angelo Volandes, MD, MPH
- Vince Mor, PhD
Learn about the cross-Core collaborations among the Ethics & Regulatory, Electronic Health Records, Biostatistics and Study Design, Patient-Centered Outcomes, Health Care Systems Interactions, Implementation Science, and
Health Equity Cores.
Moderator: Kevin Weinfurt, PhD
Panel:
- Rosa Gonzalez-Guarda, PhD, MPH, RN, CPH, FAAN
- Keith Marsolo, PhD
- Emily O'Brien, PhD, FAHA
- Greg Simon, MD, MPH
- Jeremy Sugarman, MD, MPH, MA
Keynote: Focus on Health Equity
Discuss national priorities for improving health equity. Describe principles and opportunities for integrating a health equity lens throughout the research life cycle.
Eliseo J. Perez-Stable
Panel Discussion
Discuss experiences bringing a health equity lens into ePCTS.
Moderator: Rosa Gonzalez-Guarda, PhD, MPH, RN, CPH, FAAN
Panel:
Focus on Health Equity: The ePCT Landscape/Ecosystem
Identify what national programs and initiatives are doing to improve health equity. Discuss best practices for engaging minoritized and other underrepresented communities to improve health equity. Examine the impact of these initiatives and how lessons are disseminated across different stakeholder groups.
Moderator: Cherise Harrington, PhD, MPH
Discussion from New NIH Collaboratory Trial (INSPIRE)
Update on lessons learned from Year 1, ongoing transition issues, sustainability for the UH3 phase, any challenges, and discussion of data sharing plans.
Shruti Gohil, MD, MPH; Rich Platt, MD, MSc
Top Barriers/Challenges and Recent Generalizable Lessons Learned From the UH3s
Discussion from NIH Collaboratory Trials on barriers, challenges, and lessons learned.
- Miguel Vazquez, MD (ICD-Pieces)
- Corita Grudzen, MD, MSHS (PRIM-ER)
- Stacy Sterling, DrPH, MSW (GGC4H)
- James Tulsky, MD; Angelo Volandes, MD, MPH (ACP PEACE)
- Hrishikesh Chakraborty, DrPH (HiLo)
- Christine Goertz, DC, PhD; Adam Goode, PT, DPT, PhD; Jon Lurie, MD, MS; Hrishikesh Chakraborty, DrPH (IMPACt-LBP)
- Michael Ho, MD, PhD; Sheana Bull, PhD, MPH (Nudge)
Closing Remarks
Wendy Weber, ND, PhD, MPH; Lesley Curtis, PhD
Wednesday, May 17, 2023
Welcome and Opening Remarks
Lesley Curtis, PhD; Wendy Weber, ND, PhD, MPH
Clinical Decision Support Software in ePCTs - FDA and Regulatory Perspectives
Describe case studies from the Collaboratory and beyond illustrating challenges with clinical decision support software.
Hear from the FDA about the newly released guidance on clinical decision support software and the associated considerations and opportunities for ePCTs.
Hear about regulatory, ethical, and IRB considerations related to evaluation of clinical decision support tools.
Pearl O'Rourke, MD; Jeremy Sugarman, MD, MPH, MA
Hear about considerations related to evaluation of clinical decision support tools from the perspective of ePCT trialists.
Moderator: Greg Simon, MD, MPH
NIH and Other Requirements for ClinicalTrials.gov Reporting
Learn about requirements for registering and reporting the results of clinical trials to ClinicalTrials.gov. Hear about efforts to modernize the ClinicalTrials.gov and Protocol Registration and Results System
(PRS) databases. Review PRS options for data entry for ePCTs and discuss ways to address issues that arise in reporting.
Speaker: Stacey Arnold
What's New With Data Sharing and Repositories
Hear from the NIH about the new data sharing policy that was released in January 2023. Learn the changes and exceptions, noting that all new NIH Pragmatic Trials Collaboratory and all PRISM projects will be required to share data. Learn from the NIH various data sharing options and suggested criteria for identifying a data repository for your study.
Speaker: Taunton Paine
Discuss the different scientific goals that motivate data sharing. Discuss the resources needed to achieve each of the goals. Describe early Collaboratory experiences in the use of shared data.
Speaker: Keith Marsolo, PhD
Lightning Round - Sharing Results With Patients and Participants
Discussion about approaches to sharing results with participants and community stakeholders.
Moderator: Kevin Weinfurt, PhD
Panel:
Lessons on Data Sharing From the HEAL Bioethics Supplement
Discussion of ethical issues associated with data sharing, including lessons learned from the Bioethics Supplement.
Speaker: Stephanie Morain, PhD, MPH
How Do We Drive Change in the Incentive Structure to Promote Data Sharing?
Discuss incentives for data sharing including those for researchers, clinicians, and healthcare system leaders. Discuss how to improve patient understanding of the importance of data sharing and encourage participation.
Speaker: Adrian Hernandez, MD, MHS
Top Barriers/Challenges and Recent Generalizable Lessons Learned From the UH3s
Discussion from NIH Collaboratory Trials on barriers, challenges, and lessons learned.
- Lynn DeBar, PhD, MPH, Andrea Cook, PhD (BackInAction)
- Julie Fritz, PhD, PT (BeatPain Utah)
- Kathleen Sluka, PT, PhD (FM-TIPS)
- Andrea Cheville, MD, Jon Tilburt, MD (NOHARM)
- Natalia Morone, MD, MS (OPTIMUM)
- Ardith Doorenbos, PhD, RN, FAAN (GRACE)
Closing Remarks
Wendy Weber, ND, PhD, MPH; Lesley Curtis, PhD
NIH-Hosted Workshop: Getting the Right Evidence to Decision-Makers Faster (June 2023)
This 2-day workshop held during June 2023 explores the critical cycle of evidence generation to decision by health system leaders to implement the findings of pragmatic clinical trials (PCTs) conducted within health care systems.