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

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.

Living Textbook Video Modules

Living Textbook Video Modules

This selection of short educational videos is drawn from our 2020 Living Textbook Grand Rounds Series. The series focused on the Living Textbook and featured expert speakers guiding the audience through the life cycle of an embedded pragmatic clinical trial—from idea to funding to implementation.

Module Description
What Are Pragmatic Clinical Trials? (4:51) NIH Collaboratory investigator Dr. Lesley Curtis answers the question, "What do we mean when we talk about 'pragmatic clinical trials'?"
Designing Pragmatic Trials That Are Fit for Purpose (9:14) NIH Collaboratory investigator Dr. Lesley Curtis uses the PRECIS-2 wheel to summarize important considerations in designing pragmatic clinical trials that are fit for purpose.
Engaging With Stakeholders in Pragmatic Clinical Trials (10:35) NIH Collaboratory investigator Dr. Greg Simon discusses the importance of building partnerships and engaging with stakeholders throughout the life cycle of a pragmatic clinical trial.
Building a Study Team for a Pragmatic Clinical Trial (6:12) NIH Collaboratory investigator Dr. Lesley Curtis shares tips for building effective study teams for pragmatic clinical trials.
Designing With Implementation in Mind (16:58) NIH Collaboratory researchers Leah Tuzzio and Dr. Vince Mor discuss what it means to design a pragmatic trial with implementation in mind, and they share examples from 2 of the NIH Collaboratory Trials—ABATE Infection and PROVEN.
Pilot and Feasibility Testing: The LIRE Example (18:10) NIH Collaboratory investigator Dr. Jerry Jarvik, principal investigator of the LIRE NIH Collaboratory Trial, discusses pilot and feasibility testing in pragmatic clinical trials.
Is a Pragmatic Trial Right for Your Research Question? (3:55) Dr. Wendy Weber, the NIH project officer for the NIH Collaboratory, poses a fundamental question: Is a pragmatic clinical trial the right approach for your research question?
Finding the Right NIH Funding Opportunity (13:08) Dr. Wendy Weber, the NIH project officer for the NIH Collaboratory, shares tips for finding the right NIH funding opportunity and program official for your grant application.
Writing a Successful Grant Application (14:08) Dr. Wendy Weber, the NIH project officer for the NIH Collaboratory, offers advice for writing a successful grant application for a pragmatic clinical trial, including common pitfalls and application dos and don’ts.
Choosing the Right Study Design (18:34) NIH Collaboratory investigator Dr. Liz Turner offers insights into choosing the right design for a pragmatic clinical trial, using examples from the NIH Collaboratory Trials.
Understanding Clustering in Cluster Randomized Trials (16:54) NIH Collaboratory investigator Dr. Liz Turner explains outcome clustering in cluster randomized trials and how to account for it.
Choosing Endpoints and Outcomes in Pragmatic Clinical Trials (7:26) NIH Collaboratory researcher Dr. Devon Check summarizes key questions for choosing endpoints and outcomes in pragmatic clinical trials.
Defining Outcomes With Electronic Health Record Data (7:09) NIH Collaboratory researcher Dr. Rachel Richesson addresses the complexities of using electronic health record data to define outcomes in pragmatic clinical trials.
Assessing Data Quality (8:43) NIH Collaboratory researcher Dr. Rachel Richesson discusses the importance of assessing data quality when using electronic health record data in pragmatic clinical trials.