May 9-10, 2024 | Bethesda, MD
Main Purpose
Day 1: Hear from the newest NIH Collaboratory Trials; share challenges and lessons learned to promote successful trial conduct; discuss the evolution and current state of the NIH Collaboratory ecosystem; identify gaps and areas of opportunity for expanding the ecosystem of embedded pragmatic clinical trials (ePCTs).
Day 2: Have rich discussions on overcoming challenges in ePCTs, fostering patient engagement, and creating reusable infrastructure; share insights from seasoned NIH Collaboratory Trials on posttrial activities and moving to the next ePCT.
Agenda and Slides
Day 1: Thursday, May 9, 2024
Welcome and Opening Remarks
Wendy Weber, ND, PhD, MPH; Lesley Curtis, PhD
Highlights of the NIH Pragmatic Trials Collaboratory
Feature major accomplishments of the program; review specific requirements for the new trials; offer guidance and answer questions
Wendy Weber, ND, PhD, MPH
Ethical and Regulatory Challenges/Lessons Learned
Hear from the NIH Collaboratory Trials about ethical and regulatory challenges encountered; Discuss strategies for navigating ethical and regulatory complexities of ePCTs
Moderator: Stephanie Morain, PhD
Panel:
- Michele Balas, PhD, RN, CCRN-K, FCCM, FAAN
- Diana Burgess, PhD
- Richard Skolasky, ScD, MA
Study Design Challenges/Lessons Learned
Learn about study design issues faced by the NIH Collaboratory Trials; Share statistical and methodological considerations important for the planning phase and beyond
Moderator: Patrick Heagerty, PhD
Panel:
-
Sheana Bull, PhD, MPH
- Stephanie Fitzpatrick, PhD
- Chenchen Wang, MD, MSc
Data Access and Management Challenges/Lessons Learned
Hear from the NIH Collaboratory Trials about challenges with data access, planning for data management, and data sharing; Review methods for addressing issues related to data security, privacy, and approval for data use
Moderator: Rachel Richesson, PhD, MPH, MS, FACMI
Panel:
-
Richard Skolasky, ScD, MA
- Ed Vasilevskis, MD, MPH
Lessons and Challenges Engaging Rural Populations
Share progress on ePCTs for the prevention and management of chronic pain in rural populations, describing challenges and lessons learned; Begin communication that may lead to joint publications on methods and strategies, and/or future collaborations
Moderators: Karen Kehl, PhD, RN, FPCN
Panel:
-
Julie Fritz, PhD, PT
-
Richard Skolasky, ScD, MA
- Sebastian Tong, MD, MPH
- Katie Hadlandsmyth, PhD
Welcome and Introduction of Fireside Chat
Welcome participants, introduce the Fireside Chat, and kick off the afternoon session for all NIH Collaboratory Trials
Helene Langevin, MD, PhD; Richard Hodes, MD; David Shurtleff, PhD
Fireside Chat: Pragmatic Research and National Health Priorities
Hear thoughts on how pragmatic research can help address the nation’s top health priorities; Discuss how to maximize evidence generation from ePCTs and achieve the greatest benefits for the U.S. population
Moderator: Wendy Weber, ND, PhD, MPH
Guests:
- Monica Bertagnolli, MD
- Robert Califf, MD
State of the NIH Pragmatic Trials Collaboratory Ecosystem
Share an overview of the characteristics of trials in the NIH Collaboratory, such as populations, partner types (e.g., hospitals, primary care, community clinics, FQHCs); Discuss the evolution of the program and identify gaps and areas of opportunity
Kevin Weinfurt, PhD
Addressing Barriers to ePCTs Involving Approved Drugs
Describe barriers to conducting ePCTs involving approved drugs, including trials with repurposed drugs and A vs B trials; Explore potential ways to overcome these barriers, including how the NIH Collaboratory might contribute
Moderator: Adrian Hernandez, MD, MHS
Panel:
- Pearl O'Rourke, MD
- Kevin Bugin, PhD
- Leonard Sacks, MD
- Tracy Wang, MD, MHS, MSc
Promoting Patient Engagement in ePCTs
Review the Coordinating Center’s efforts to support patient engagement; Hear from NIH Collaboratory Trials on challenges and methods for engaging patients in ePCTs
Moderator: Steven George, PT, PhD
Panel:
- Natalia Morone, MD, MS
- Chenchen Wang, MD, MSc
Fostering Development of Up-and-Coming ePCT Investigators
Hear flash talks from NIH Collaboratory fellows
Moderator: Emily O'Brien, PhD
Presenters:
- Lindsay Ballangee, DPT
- Kaitlyn McLeod, MD
Closing Remarks
Wendy Weber, ND, PhD, MPH; Lesley Curtis, PhD
Day 2: Friday, May 10, 2024
Opening Remarks
Wendy Weber, ND, PhD, MPH; Lesley Curtis, PhD
BackInAction Results
Hear preliminary main outcomes
*No slides for this presentation
Lynn DeBar, PhD
Clinician and Health System Engagement Challenges/Lessons Learned
Hear about challenges engaging clinicians and health systems; Discuss ways to strengthen these relationships to support ePCTs; Share how trials are planning for retraining of clinical staff when there is turnover
*No slides for this panel
Moderator: Greg Simon, MD, MPH
Panel:
- Andrea Cheville, MD
- Christine Goertz, DC, PhD
- James Tulsky, MD
Data Extraction and Quality Challenges/Lessons Learned
Learn about issues encountered with EHR integration, data extraction, and data quality; Share ways to mitigate data-related challenges, such as cleaning as you go and strong investigator–analytic team collaborations
Moderator: Keith Marsolo, PhD
Panel:
- Dana Dailey, PT, PhD
- Shruti Gohil, MD, MPH
- Corita Grudzen, MD, MSHS
Expanding the ePCT Ecosystem to Better Serve Minoritized Communities
Discuss the increasing burden on minoritized communities and health systems serving them; Review the makeup of NIH Collaboratory Trial sites (academic medical centers, community hospitals, etc.) and explore how to expand the types
Moderator: Cherise Harrington, PhD, MPH
Panel:
-
Eliseo J. Pérez-Stable, MD
- Stephanie Fitzpatrick, PhD
- Sebastian Tong, MD, MPH
Building and Sustaining Reusable Infrastructure for ePCTs
Describe reusable infrastructure being used to promote ePCTs outside the NIH Collaboratory; Explore different models for sustaining infrastructure for ePCTs
Moderator: Christine Goertz, DC, PhD
Panel:
- Lynn DeBar, PhD
- Julie Fritz, PhD, PT
- Greg Simon, MD, MPH
Exploring the Generative Investment of an ePCT for Catalyzing Research
Discuss elements of research platforms in NIH Collaboratory Trials most at risk of dissipating and needing to be rebuilt for future research; Describe which elements could be reused (e.g., relationships, teams, interventions, EHR/IT systems)
Moderator: Greg Simon, MD, MPH
Panel:
- Susan Huang, MD, MPH
- Natalia Morone, MD, MS
- Jon Tilburt, MD
Planning Effectively for Posttrial Activities
Discuss preparing for dissemination and sustainment or de-implementation before results are known; describe considerations for when and how to share results with partners and the public; Learn ways to share trial tools more widely, and explore Dissemination and Implementation R01s
Moderator: Hayden Bosworth, PhD
Panel:
- Shruti Gohil, MD, MPH
- Corita Grudzen, MD, MSHS
- Stacy Sterling, DrPH, MSW
How to Transition to the Next Research Opportunity
Share insights from NIH Collaboratory Trials that informed subsequent pragmatic trials; Learn which aspects investigators preserved in subsequent trials, and which aspects they discontinued or added
Moderator: Rich Platt, MD, MSc
Panel:
- Lynn DeBar, PhD
- Mike Ho, MD, PhD
- Angelo Volandes, MD, MPH
Closing Remarks
Wendy Weber, ND, PhD, MPH; Lesley Curtis, PhD
NIH-Hosted Workshop: Going From Zero to 100: Generating Evidence Through Pragmatic Research to Address Pressing Healthcare Issues (July 2024)
This 2-day workshop held during July 2024 explores the preparatory actions researchers can take in the planning and application phase (Phase Zero) to ensure pragmatic clinical trials yield actionable evidence for various settings.