May 28-29, 2025 | Bethesda, MD
Main Purpose
Day 1: Hear from the newest and sunsetting NIH Collaboratory Trials; share challenges and lessons learned to promote successful trial conduct; discuss considerations for future embedded pragmatic clinical trials (ePCTs) such as understanding decision-maker perspectives and improving implementation of ePCT findings.
Day 2: Hear from the newest and recently transitioned NIH Collaboratory Trials; have rich discussions on topics including methods for building community relationships, lessons on using data repositories, and meeting posttrial responsibilities.
Agenda and Slides
Day 1: Wednesday, May 28, 2025
Welcome and Opening Remarks
Wendy Weber, ND, PhD, MPH; Lesley Curtis, PhD
The Future of ePCTs: Views From the Field
Discuss the future of ePCTs including what issues need to be addressed; Understand the current priorities, major initiatives, and cross-cutting activities of related research networks; Explore how the NIH Collaboratory might collaborate and contribute
Moderator: Adrian Hernandez, MD, MHS
Panel:
- Lora Reineck, MD, MS
- Amy Patterson, MD
- Susan Mitchell, MD, MPH
- Vincent Mor, PhD
- Greg Simon, MD, MPH
Expanding ePCTs in Primary Care: How Do We Get There?
Describe lessons from implementing pragmatic trials in the primary care setting; Explore challenges of conducting research in primary care; Identify successful methods and knowledge gaps for research embedded in primary care
Moderator: Wendy Weber, ND, PhD, MPH
Panel:
- Julie Fritz, PhD, PT
- Natalia Morone, MD, MS
- Sebastian Tong, MD, MPH
Perspectives From Sunsetting NIH Collaboratory Trials on Next Steps for ePCTs
Share investigator thoughts on future directions for pragmatic research as their NIH Collaboratory Trials end; Discuss what the NIH Collaboratory can do to help support future trials and increase national capacity for ePCTs
Moderator: Christine Goertz, DC, PhD
Panel:
- Stacy Sterling, DrPH, MSW
- Shruti Gohil, MD, MPH
- Andrea Cook, PhD
Networking and Ask the Experts
Engage in small group discussion around topics of interest; Consult with Core Chairs and colleagues on issues your trial is facing
Report-Out From Networking Sessions
Describe action items for ePCTs identified in the breakout groups; Share common challenges, best practices, or areas of potential collaboration from the networking session with the group
APA-SM Flash Talk
Describe lessons learned, challenges overcome, and ongoing issues
Jennifer Kawi, PhD, MSN, FNP-BC, CNE, FAAN; Jane Bolin, PhD, JD, RN; Hulin Wu, PhD, MS
Significance in ePCTs: P Values vs Decision-Maker Perspectives
Discuss how investigators are considering decision-maker perspectives in their trials; Share lessons that prompt rethinking of measures or design in future trials; Explore how to bring scientific rigor to outcomes that matter in the real world
Moderator: Gregory Simon, MD, MPH
Panel:
- Richard Platt, MD
- Corita Grudzen, MD, MSHS, FACEP
- Liz Turner, PhD
Improving Implementation of Digital Tools Developed in ePCTs
Discuss the decision process for whether and how to integrate digital tools into the EHR (or not); Explore the human factors that affect intervention uptake, fidelity, and sustainability
Moderator: Steven George, PT, PhD, FAPTA
Guests:
- Keith Marsolo, PhD
- Michele Balas, PhD, RN, CCRN-K, FCCM, FAAN
- Andrea Cheville, MD, MSCE
- Mike Ho, MD, PhD
Lightning Round: NIH Collaboratory Trial Results
Describe results, surprises, lessons learned, and future plans
Shruti Gohil, MD, MPH; Corita Grudzen, MD, MSHS, FACEP; Mike Ho, MD, PhD; Angelo Volandes, MD, MPH; Hrishikesh Chakraborty, PhD
Closing Remarks
Wendy Weber, ND, PhD, MPH; Lesley Curtis, PhD
Day 2: Thursday, May 29, 2025
Opening Remarks
Wendy Weber, ND, PhD, MPH; Lesley Curtis, PhD
LungSMART Utah Flash Talk
Describe lessons learned, challenges overcome, and ongoing issues
David Wetter, PhD, MS; Guilherme Del Fiol, MD, PhD; Ken Kawamoto, MD, PhD
Emerging Issues from Recently Transitioned Trials
Discuss lessons learned and challenges encountered in NIH Collaboratory Trials; Hear advice from seasoned investigators
Moderator: Angelo Volandes, MD, MPH
Panel:
- Stephanie Fitzpatrick, PhD
- Elizabeth Wick, MD
- Chenchen Wang, MD, MSc
Building Relationships With Communities in Pragmatic Research
Learn how community relationships have enriched NIH Collaboratory Trials; Discuss impediments to meaningful community engagement in pragmatic trials; Describe successful methods for building relationships with communities
Moderator: Cherise Harrington, PhD, MPH
Panel:
- David Wetter, PhD, MS
- Jennifer Kawi, PhD, MSN, FNP-BC, CNE, FAAN
- Sebastian Tong, MD, MPH
- Kathleen Sluka, PT, PhD
STEP-2 Flash Talk
Describe lessons learned, challenges overcome, and ongoing issues
Rachel Winer, PhD, MPH; Amanda Petrik, PhD; Jasmin Tiro, PhD
What We Owe XXX After a Trial
Share experiences of NIH Collaboratory Trials in meeting posttrial responsibilities; Explore lessons and areas of opportunity related to the sharing of research findings
Moderators: Pearl O'Rourke, MD; Jeremy Sugarman, MD, MPH, MA
Panel:
- Stephanie Morain, PhD
- Hayden Bosworth, PhD
- Angelo Volandes, MD, MPH
How Do We Support Broad Implementation of ePCT Findings?
Identify challenges and opportunities for investigators in implementing findings across a wide variety of health systems and communities; Review methods to help ensure all populations have access to sustainable interventions that could benefit them
Moderator: Rosa Gonzalez-Guarda, PhD, MPH, RN, CPH, FAAN
Panel:
- Ardith Doorenbos, PhD, RN, FAAN
- Julie Fritz, PhD, PT
- Kevin McLaughlin, DPT
Demystifying Data Sharing
Describe the process NIH Collaboratory Trials used to select a data repository; Discuss challenges encountered when using repositories; Share tips to streamline depositing data
Moderator: Keith Marsolo, PhD
Panel:
- Diana Burgess, PhD
- Andrea Cheville, MD
- Andrea Cook, PhD
Monitoring and Navigating Changes in Usual Care
Explore how NIH Collaboratory Trials are documenting and monitoring usual care; Describe considerations for interim data pulls and futility decisions; Discuss impacts of an evolving healthcare setting and shifts in ePCT approaches needed
Moderator: Emily O'Brien, PhD
Panel:
- Rachel Winer, PhD, MPH
- Christine Goertz, DC, PhD
- Shruti Gohil, MD, MPH
Closing Remarks
Wendy Weber, ND, PhD, MPH; Lesley Curtis, PhD
NIH-Hosted Workshop: Digging into Dilemmas of Pragmatic Clinical Trials (November 2025)
This 2-day workshop held in November 2025 introduces concepts in considerations for research in healthcare systems across a variety of communities; platform trials as an emerging method; implications of pragmatic trials with null findings for future pragmatic research; and the role of pragmatic trials in comparative effectiveness research of artificial intelligence algorithms.