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May 2024 Annual Steering Committee Meeting

Posted on by Lauren Stewart

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.

Fireside chat 3

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.

 

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Posted on by dcridigital

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Workshop Summary (example)

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Videocast Recording: Day 2 (example)

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Podcast Blog: Reflections on the NIH Collaboratory: Highlights from the Past and Hopes for the Future

Posted on by Gina Uhlenbrauck

A podcast discussion with Drs. Adrian Hernandez and Kevin Weinfurt

NIH Collaboratory investigators and podcast moderators Drs. Adrian Hernandez and Kevin Weinfurt took time on the latest podcast to discuss the important work done by the NIH Collaboratory this year and what’s next.

Dr. Weinfurt spoke about his excitement to begin seeing results from NIH Collaboratory Trials in the coming years, and how those results will be received by various stakeholders. Specifically, he referenced groundbreaking results presented at a recent Grand Rounds by Dr. Greg Simon on the Suicide Prevention Outcomes Trial (SPOT), a project looking at the use of machine learning to predict patient behaviors and outcomes. Dr. Simon recently spoke on the podcast about the implications of using computer algorithms not only to prevent suicides, but also in broader healthcare settings to predict a variety of patient outcomes.

Dr. Hernandez noted that the NIH Collaboratory Trials to date have been truly pragmatic trials, and could offer valuable insights to inform the next wave of projects in the coming year. Dr. Weinfurt agreed that investigators could learn from these original NIH Collaboratory Trials, as well as reference The Living Textbook, to develop more mature research questions in the future. In particular, he said he looks forward to moving in the direction of “A versus B testing” in future trials.

Both Drs. Hernandez and Weinfurt said they expect that the Revised Common Rule will present a challenge for the upcoming year, as the research community explores how to run trials within the new regulations. Dr. Hernandez noted that there has often been an emphasis on the front half of the trials, and less clarity around the back half, when the data is collected and analyzed.  Refocusing on this later portion of trials, he said, will be crucial in order to ensure data is disseminated properly and ultimately used to create real change for patients.

In terms of expectations for the future, Dr. Hernandez said he hopes that there will be more data streams available, as companies like Amazon begin to move into the health data space. Both he and Dr. Weinfurt shared a hope that health systems will ultimately be able to pull data from a number of sources, from electronic health records (EHRs) to wearable devices, creating richer data sets to examine outcomes. In addition, Dr. Weinfurt proposed that moving forward, the NIH Collaboratory should include more educational opportunities for the research community on pragmatic trials, in order to teach investigators not only how to run these trials but also what to do with the results.

The NIH Collaboratory looks forward to presenting regular educational opportunities, in the form of weekly Grand Rounds presentations and monthly podcasts.

Read the full podcast transcript here.