Inclusion of Diverse Participants in Pragmatic Clinical Trials: NIH-Hosted Workshop (May-August 2021)

In 2021, NIH Collaboratory Grand Rounds held a special workshop series to provide insights about planning for diversity, engaging participants, learning from implementation science to maximize diversity, and developing a pipeline of diverse investigators. The Grand Rounds series included moderated panel discussions, case examples from the NIH Collaboratory Trials, and culminated with a podcast discussion from a panel of experts.

Agenda and Slides

Session 1: May 14, 2021: Keynote: Diverse Representation Among Clinical Trial Participants: Why it is Important and How Can We Improve

Moderator: Kanecia Zimmerman, MD
Speaker: Clyde W. Yancy, MD, MSc

Session 2: June 4, 2021: Planning for Diversity: Stakeholder Engagement and Site Selection to Maximize Diversity

Moderator: Wendy Weber, ND, PhD, MPH
Speakers: Julie Fritz, PhD, PT; David Wetter, PhD, MS; Gloria Coronado, PhD; Amanda Petrik, MS

Session 3: June 25, 2021: Meeting Participants Where They Are: Outreach, Trust, and Consent to Maximize Diversity

Moderator: Emily O'Brien, PhD
Speakers: Jonathan Jackson, PhD; Judith Schlaeger, PhD, CNM, Lac, FAAN; Stacy Sterling, DrPH, MSW, MPH

Session 4: July 16, 2021: Maximizing Diversity in PCTs: What Can We Learn From Implementation Trials

Moderator: David Chambers, DPhil
Speakers: Amanda Midboe, PhD; Anne Trontell, MD, MPS

Session 5: July 30, 2021: Diversity in the PCT Ecosystem: How Do We Develop a Pipeline of Diverse Investigators and Leaders in PCTs?

Moderator: Lesley Curtis, PhD
Speakers: Marie Bernard, MD; George Mensah, MD; Natalia Morone, MD

Session 6: August 2, 2021: Podcast: Summary Expert Panel Discussion

Moderator: Robin Boineau, MD, MA
Speakers: Kanecia Zimmerman, MD; Wendy Weber, ND, PhD, MPH; Emily O'Brien, PhD; David Chambers, DPhil; Lesley Curtis, PhD

ePCT Workshop: Health Care Systems Research Network (Virtual, May 2021)

Logo for HCSRN 2021This virtual workshop introduced concepts in the design, conduct, and implementation of ePCTs, with a particular focus on methods relevant to health services researchers. The workshop provided a greater understanding of the investigative opportunities for embedded health systems research, along with strategies for conducting clinical trials that provide real-world evidence necessary to inform both practice and policy. Firsthand ePCT experiences and case studies from the Collaboratory Demonstration Projects illustrated the topics presented.

Agenda and Slides

Day 1: May 11

Session 1: What Are Embedded PCTs (ePCTs)?

Wendy Weber, ND, PhD, MPH

View presentation

Session 2: Measuring Outcomes

Emily O'Brien, PhD

View presentation

Session 3: ePCT Design & Analysis

Patrick Heagerty, PhD

View presentation

Day 2: May 12

Session 1: Pilot & Feasibility Testing

Wendy Weber, ND, PhD, MPH

View presentation

Session 2: Ethical & Regulatory Oversight Considerations

Stephanie Morain, PhD, MPH

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Session 3: Writing a Compelling Grant Application

Marcel Salive, MD, MPH

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Session 4: ICD-Pieces Case Study

Miguel Vazquez, MD

View presentation

Session 5: LIRE Case Study

Jeffrey (Jerry) G. Jarvik, MD, MPH

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Session 6: OPTIMUM Case Study

Natalia Morone, MD

View presentation

EHR Workshop Video Modules

EHR Video Modules

This selection of short educational videos is drawn from our 2020 EHR Workshop Grand Rounds Series, “Advances at the Intersection of Digital Health, Electronic Health Records and Pragmatic Clinical Trials.” The series highlighted advances in digital health, new approaches and evolving standards for electronic health records (EHRs), and implications for researchers conducting pragmatic trials.

Advances at the Intersection of Digital Health, EHRs, and PCTs: NIH-Hosted Workshop (May-July 2020)

May-July 2020: In 2020, NIH Collaboratory Grand Rounds held a special workshop series to explore challenges and opportunities in using electronic health records (EHRs) in pragmatic clinical trials. The series highlighted advances in digital health, new approaches and evolving standards for EHRs, and implications for researchers conducting pragmatic trials. The Grand Rounds series included moderated panel discussions that focused on the use of digital technologies in pragmatic clinical trials, case examples from the NIH Collaboratory Trials, and recent initiatives from the Office of the National Coordinator for Health Information Technology to reshape standards and drive the evolution of EHRs in healthcare and research. The series culminated with a podcast discussion from a panel of experts.

Agenda and Slides

 

Session 1: May 1, 2020: Keynote: Can the COVID-19 Crisis Lead to Reformation of the Evidence Generation Ecosystem?

Speaker: Robert Califf, MD, MACC

Session 2: May 8, 2020: Real World Evidence: Contemporary Experience and Future Directions

Speakers: Jacqueline Corrigan-Curay, JD, MD; Joshua C. Denny, MD, MS, FACMI
Moderator: Patrick J. Heagerty, PhD

Session 3: May 29, 2020: Experiences From the Collaboratory PCTs

Speakers: Jeffrey [Jerry] G. Jarvik, MD, MPH; Lynn DeBar, PhD; Doug Zatzick, MD; Vince Mor, PhD
Moderator: Wendy Weber, ND, PhD, MPH

Session 4: June 26, 2020: Keys to Success in the Evolving EHRs Environment

Speakers: Teresa Zayas-Cabán, PhD; George [Holt] Oliver, MD, PhD; Christopher A. Longhurst, MD, MS; Rachel Richesson, PhD, MPH
Moderator: Keith Marsolo, PhD

Session 5: July 8, 2020: Podcast: Summary Expert Panel Discussion

Speakers: Patrick J. Heagerty, PhD; Keith Marsolo, PhD; Wendy Weber, ND, PhD, MPH
Moderator: Lesley H. Curtis, PhD

EHR Video Modules

Watch our selection of short educational videos drawn from this 2020 EHR Workshop Grand Rounds Series. The series highlighted advances in digital health, new approaches and evolving standards for electronic health records (EHRs), and implications for researchers conducting pragmatic trials.

ePCT Seminar: American Society of Nephrology (November 2019)

November 8, 2019: This seminar, offered by the NIH Collaboratory in partnership with the American Society of Nephrology, was held in Washington, D.C. during ASN Kidney Week. The seminar sessions provided an introduction to concepts in the design of embedded pragmatic clinical trials (ePCTs), with a focus on interventions that are relevant to the nephrology research community. All presentations are downloadable in PDF format.

Logo for ASN Kidney Week 2019

Agenda and Slides

Embedded Pragmatic Clinical Trials: Accelerating Evidence Generation in Nephrology

Welcome and Introduction

Catherine M. Meyers, MD
Susan R. Mendley, MD

Session 1: Opportunities for Embedded Pragmatic Clinical Trials in Nephrology

Laura Dember, MD

Session 2: Design and Analysis: Strategies for Embedded Pragmatic Clinical Trials

Qilu Yu, PhD

Session 3: Engaging Stakeholders and Aligning with Health System Partners

Miguel Vazquez, MD

Session 4: Designing for Post-Trial Implementation

Wynne Norton, PhD

Essentials of ePCTs Workshop: AcademyHealth (June 2019)

June 1, 2019: The NIH Pragmatic Trials Collaboratory hosted a Pre-Conference Workshop at the AcademyHealth 2019 Annual Conference. This training workshop introduced concepts in the design, analysis, and implementation of embedded pragmatic clinical trials (ePCTs) and provided firsthand ePCT experiences from NIH Pragmatic Trials Collaboratory Trials.

Agenda and Slides

Welcome and Introduction

Catherine Meyers, MD

Session 1: What are Embedded Pragmatic Clinical Trials (ePCTs)?
Catherine Meyers, MD

Session 2: Engaging Stakeholders & Aligning with Health System Partners
Leah Tuzzio, MPH

Session 3: Measuring Outcomes
Emily O'Brien, PhD

Session 4: ePCT Design
David Murray, PhD

Session 5: ePCT Analysis
David Murray, PhD

Session 6: ePCTs in Context: Panel Discussion with NIH Collaboratory Trial PIs

Moderator: Kevin Weinfurt, PhD

Panel:

    • Susan Huang, MD, MPH (ABATE)
    • Vince Mor, PhD (PROVEN)

Session 7: Pilot & Feasibility Testing
Wendy Weber, ND, PhD, MPH

Session 8: Ethical & Regulatory Oversight Considerations
Kevin Weinfurt, PhD; Julie Kaneshiro, MA

Session 9: Dissemination & Implementation
Wynne Norton, PhD

Session 10: ePCTs in Context: Panel Discussion with NIH Collaboratory Trial PIs

Moderator: Kevin Weinfurt, PhD

Panel:

    • Susan Mitchell, MD, MPH (PROVEN)
    • Laura Dember, MD (TiME)

Session 11: Assembling an ePCT Team & Writing a Grant Application
Robin Boineau, MD, MA; Marcel Salive, MD, MPH

Next Steps

Kevin Weinfurt, PhD