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

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

A workshop focused on the inclusion of diverse participants in pragmatic clinical trials with insights about planning for diversity, engaging participants, learning from implementation science to maximize diversity, and developing a pipeline of diverse investigators

August 2, 2021: Grand Rounds Podcast Expert Panel Discussion Summarizing the Diversity Workshop Series is Available

Robin Elizabeth Boineau, M.D., M.A.

In the latest episode of the NIH Collaboratory Grand Rounds podcast, Dr. Robin Boineau concludes the diversity workshop series, ‘Inclusion of Diverse Participants in Pragmatic Clinical Trials’ in a discussion with Dr. David Chambers, Dr. Lesley Curtis, Dr. Emily O’Brien, Dr. Wendy Weber, and Dr. Kanecia Zimmerman.

Listen to all 5 episodes in the Grand Rounds Diversity Workshop Series here:

 

Podcast August 2, 2021: Diversity Workshop Series: Increasing Diversity in Pragmatic Clinical Trials (Dr. Boineau, Dr. Chambers, Dr. Curtis, Dr. O’Brien, Dr. Weber, Dr. Zimmerman)

This podcast summarizes the series on ‘Inclusion of Diverse Participants in Pragmatic Clinical Trials’ with a panel discussion with Dr. Robin Boineau, Dr. David Chambers, Dr. Lesley Curtis, Dr. Emily O’Brien, Dr. Wendy Weber, and Dr. Kanecia Zimmerman.

Click on the recording below to listen to the podcast.

Want to hear more? View the full Diversity workshop series Grand Rounds presentation from

May 14, 2021;  June 4, 2021; June 25, 2021; July 16, 2021; and July 30, 2021.

For alerts about new episodes, subscribe free on Apple Podcasts or SoundCloud.

Read the transcript.

July 27, 2021: Diversity Workshop Continues With Diversifying the Pipeline of PCT Investigators and Leaders

The NIH Collaboratory is using its popular ePCT Grand Rounds platform for a special webinar series on diversity in pragmatic clinical trials.

In this Friday’s session—“Diversity in the PCT Ecosystem – How Do We Develop a Pipeline of Diverse Investigators and Leaders in PCTs?”—Dr. Lesley Curtis, co–principal investigator of the NIH Collaboratory Coordinating Center, will host a panel of investigators for a discussion about strategies for developing a diverse pipeline of researchers and leaders in the field of pragmatic clinical research.

The panelists will include:

  • Dr. Marie Bernard, deputy director of the National Institute on Aging and acting NIH chief officer for scientific workforce diversity
  • Dr. George Mensah of the Center for Translation Research and Implementation Science at the National Heart, Lung, and Blood Institute
  • Dr. Natalia Morone of Boston University, principal investigator of OPTIMUM, an NIH Collaboratory Trial

The Grand Rounds session will be held on Friday, July 30, at 1:00 pm eastern. Join the online meeting.

The complete diversity workshop series includes:

All sessions are free and open to the public; no registration is required. Recordings will be archived on the Grand Rounds website.

 

Headshots of Lesley Curtis, Marie Bernard, George Mensah, and Natalia Morone
Left to right: Dr. Lesley Curtis, Dr. Marie Bernard, Dr. George Mensah, and Dr. Natalia Morone

July 26, 2021: NIH Collaboratory Leaders Discuss PRISM Projects, New Initiatives, and the Future of the Program

In a recent interview, Dr. Wendy Weber shared that the National Advisory Council for Complementary and Integrative Health has approved a concept for the NIH Collaboratory to continue with the support of NIH Institutes and Centers, as the program completes its term as an NIH Common Fund initiative.

 

 

“We’re quite excited for some new directions in where we’re going to head with this program, and really excited that we’ve identified a number of partners across the NIH as different Centers, Institutes, and Offices that want to continue this program and want to continue to do research embedded in healthcare systems,” Weber said.

Weber is the branch chief for the Clinical Research in Complementary and Integrative Health Branch in the Division of Extramural Research at the National Center for Complementary and Integrative Health (NCCIH) and serves as the program officer for the NIH Collaboratory.

“I think one new direction for us is looking at how do we address health disparities in healthcare systems, what types of interventions can actually improve those disparities and improve the quality of care so that we have less differences in the way patients are treated within the healthcare delivery system,” Weber said.

We interviewed Weber after the NIH Collaboratory’s annual steering committee meeting, along with Dr. Robin Boineau, the project scientist for the NIH Collaboratory, and Dr. Kevin Weinfurt, a professor in population health sciences at Duke University and a co–principal investigator for the NIH Collaboratory Coordinating Center. View the full interview.

The 3 leaders talked about the program’s newest NIH Collaboratory Trials—BeatPain Utah and GRACE—and their role in advancing the goals of the NIH Collaboratory. They also discussed focus areas for the coming year, including greater attention to implementation science outcomes, diversity in pragmatic trials, and lessons from the COVID-19 pandemic.

“[BeatPain Utah and GRACE] are helping the Collaboratory to learn how to design, analyze, and interpret adaptive designs,” said Weinfurt. “These are our 2 first trials where we’re using adaptive designs. One of the goals of the Collaboratory is to generate generalizable knowledge about how to do pragmatic trials, so we like these types of learning opportunities,” he said.

Boineau highlighted the Diversity Workshop Grand Rounds Series, which began in May and is ongoing. The series is focused on strategies for improving diversity in pragmatic clinical trials and is “an important next step to really think together about where we can go and what we can do to really build this community of investigators and participants,” Boineau said.

 

Screen shot of Dr. Wendy Weber interview
Dr. Wendy Weber of NCCIH, program officer for the NIH Collaboratory

July 16, 2021: Inclusion of Diverse Participants in Pragmatic Clinical Trials: Maximizing Diversity in PCTs – What Can We Learn From Implementation Trials? (David Chambers, DPhil; Amanda Midboe, PhD; Anne Trontell, MD, MPH)

Speakers

Panel:
Amanda Midboe, PhD
Center for Innovation to Implementation
U.S. Department of Veterans Affairs
Chair of the Implementation Science Work Group for the NIH-DOD-VA Pain Management Collaboratory

Anne Trontell, MD, MPH
Associate Director
Clinical Effectiveness and Decision Science Program
Patient-Centered Outcomes Research Institute (PCORI)

Guest Moderator:
David Chambers, DPhil
Deputy Director for Implementation Science
Office of the Director in the Division of Cancer Control and Population Sciences (DCCPS)
National Cancer Institute (NCI)
National Institutes of Health (NIH)

Topic

Inclusion of Diverse Participants in Pragmatic Clinical Trials: Maximizing Diversity in PCTs – What Can We Learn From Implementation Trials?

Keywords

Dissemination research; Implementation research; Participant engagement; Participant diversity; Health equity; PCORI; Ci2i

Key Points

  • The study of methods to best implement and disseminate interventions in diverse groups is crucial to the ultimate goal of benefiting population health.

  • Patient-centered outcomes are important measures to determine the total effectiveness of any health intervention.

  • By engaging the community in which research takes place and treating patients as partners in the development of implementation strategies, we increase diverse participation and improve patient retention.

  • Targeted recruitment strategies that leverage administrative data increase diverse study participation.

  • Outreach materials and methods that are tailored and adapted to the local culture and colloquial language are effective in engaging diverse populations.

Discussion Themes

Are there any ethical issues raised when underserved populations receive monetary incentives to participate in research trials?

What are the challenges of identifying diverse potential participants from the medical record or administrative data?

Do efforts to increase diversity in the study team improve the engagement and retention of a diverse study population?

Read more about methods to increase diversity in implementation trials at the Patient-Centered Outcomes Research Institute (PCORI) and the Center for Innovation to Implementation (Ci2i).

Tags

#pctGR, @Collaboratory1

July 13, 2021: Diversity Workshop Continues With Lessons From Implementation Trials

The NIH Collaboratory is using its popular ePCT Grand Rounds platform for a special webinar series on diversity in pragmatic clinical trials.

In this Friday’s session—“Maximizing Diversity in PCTs – What Can We Learn From Implementation Trials?”—Dr. David Chambers of the National Cancer Institute (NCI) will facilitate a discussion about lessons from implementation science for maximizing participant diversity in pragmatic clinical trials. Dr. Chambers is deputy director for implementation science in the Office of the Director in the NCI’s Division of Cancer Control and Population Sciences.

The panelists will include:

  • Dr. Amanda Midboe of the US Department of Veterans Affairs, chair of the Implementation Science Work Group for the NIH-DOD-VA Pain Management Collaboratory
  • Dr. Anne Trontell, associate director in the Clinical Effectiveness and Decision Science Program at the Patient-Centered Outcomes Research Institute (PCORI)

The Grand Rounds session will be held on Friday, July 16, at 1:00 pm eastern. Join the online meeting.

Other upcoming sessions in the diversity workshop series include:

All sessions are free and open to the public; no registration is required. Recordings will be archived on the Grand Rounds website.

Headshots of Drs. David Chambers, Amanda Midboe, and Anne Trontell
Left to right: Drs. David Chambers, Amanda Midboe, and Anne Trontell

June 22, 2021: Diversity Workshop Continues With Meeting Participants Where They Are

The NIH Collaboratory is using its popular ePCT Grand Rounds platform for a special webinar series on diversity in pragmatic clinical trials.

In this Friday’s session—“Meeting Participants Where They Are – Outreach, Trust, and Consent to Maximize Diversity”—Dr. Wendy Weber of the National Center for Complementary and Integrative Health will host a panel of investigators for a discussion about strategies for maximizing participant diversity in pragmatic clinical trials by improving outreach and building trust.

The panel will include:

  • Dr. Jonathan Jackson, executive director of the Community Access, Recruitment, and Engagement (CARE) Research Center at Massachusetts General Hospital and Harvard Medical School
  • Dr. Judith Schlaeger of the University of Illinois at Chicago, co–principal investigator of GRACE, an NIH Collaboratory Demonstration Project
  • Dr. Stacy Sterling of the Kaiser Permanente Division of Research, Northern California, co–principal investigator of GGC4H, an NIH Collaboratory Demonstration Project

The Grand Rounds session will be held on Friday, June 25, at 1:00 pm eastern. Join the online meeting.

Other upcoming sessions in the diversity workshop series include:

All sessions are free and open to the public; no registration is required. Recordings will be archived on the Grand Rounds website.

Headshots of Emily O'Brien, Jonathan Jackson, Judith Schlaeger, and Stacy Sterling
Left to right: Drs. Emily O’Brien, Jonathan Jackson, Judith Schlaeger, and Stacy Sterling

June 2, 2021: Diversity Workshop Continues With Strategies for Site Selection and Stakeholder Engagement

The NIH Collaboratory is using its popular ePCT Grand Rounds platform for a special webinar series on diversity in pragmatic clinical trials.

In this Friday’s session—“Planning for Diversity – Stakeholder Engagement and Site Selection to Maximize Diversity”—Dr. Wendy Weber of the National Center for Complementary and Integrative Health will host investigators from 2 of the NIH Collaboratory Demonstration Projects for a discussion about strategies for site selection and stakeholder engagement to maximize diversity.

  • In BeatPain Utah, Dr. Julie Fritz, Dr. David Wetter, and their team are designing interventions in federally qualified health center (FQHC) clinics to overcome barriers specific to rural and lower-income communities through innovative use of telehealth resources.
  • In STOP CRC, Dr. Gloria Coronado, Amanda Petrik, and their team worked with FQHC clinics to improve colorectal cancer screening rates in racial/ethnic minority and low-income populations.

The Grand Rounds session will be held on Friday, June 4, at 1:00 pm eastern. Join the online meeting.

Other upcoming sessions in the diversity workshop series include:

All sessions are free and open to the public; no registration is required. Recordings will be archived on the Grand Rounds website.

May 10, 2021: Dr. Clyde Yancy to Give Keynote Address This Friday to Launch Diversity Workshop Grand Rounds Series

Photographs of Dr. Clyde Yancy on the left and Dr. Kanecia Zimmerman on the right
Dr. Clyde Yancy (left) and Dr. Kanecia Zimmerman (right)

The NIH Collaboratory this Friday, May 14, will use its popular ePCT Grand Rounds platform to launch a special workshop series on diversity in pragmatic clinical trials.

Dr. Clyde Yancy of Northwestern University will begin the series with a keynote address, “Diverse Representation Among Clinical Trial Participants: Why It Is Important and How We Can Improve.” Dr. Kanecia Zimmerman of Duke University will facilitate the discussion. The Grand Rounds session will be held on Friday, May 14, at 1:00 pm eastern. Join the online meeting.

The webinar series—Inclusion of Diverse Participants in Pragmatic Clinical Trials—will focus on increasing engagement of diverse participants and building trust, recruiting diverse research sites, learning from implementation science to maximize diversity, and developing a pipeline of trainees from underrepresented groups to be leaders in pragmatic clinical research.

Other upcoming sessions in the diversity workshop series include:

All sessions are free and open to the public; no registration is required. Recordings will be archived on the Grand Rounds website.