Materials and videocast recordings are now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Going From Zero to 100: Generating Evidence Through Pragmatic Research to Address Pressing Healthcare Issues.“ The 2-day workshop, hosted by the NIH, featured a keynote address by NIH Director Monica Bertagnolli exploring how to identify high-priority healthcare issues that require the effort, time, and funding of a clinical trial.
The first day of the workshop focused on “Phase Zero,” the preparatory phase of pragmatic research in which investigators explore how to align their research question with the priorities of patients, funders, and healthcare systems to address urgent issues and generate actionable evidence. The second day of the workshop explored challenges associated with launching a pragmatic trial, including ensuring an interoperable data set, enrolling a representative patient population, and securing contracts, data use agreements, and institutional review board approval.
Access the complete workshop materials, including slides and videocast recordings.
Session 1: Phase Zero: Getting the Research Question Right
Session 1 provided real-world examples of how investigators developed their research questions with the help of patients, funders, and healthcare system partners. This “Phase Zero” in pragmatic trials research includes framing the research question in the right way and selecting meaningful outcomes. Access the complete workshop materials and videocast recordings.
Panelists: Kevin McLaughlin, Kushang Patel, Andrea Cheville, Gregory Simon; Moderator: Kevin Weinfurt
Session 2: Engagement as the Cornerstone in Pragmatic Research
Session 2 explored engagement with research partners, including real-world examples of how and when researchers identified and approached frontline clinicians, patients, funders, and community partners. Panelists shared how best to convey information in a way that builds trustworthiness and a foundation for meaningful engagement over time. Access the complete workshop materials and videocast recordings.
Panelists: Natalia Morone, Julie Fritz, Anna Krupp, Sebastian Tong; Moderator: Gregory Simon
Session 3: How to Use Data From Disparate Data Systems
Session 3 focused on making sense of disparate data systems early in the research process and ensuring that an interoperable data set is ready for analysis at the end of the trial. Panelists discussed pros and cons of adhering to a common data model, ways of simplifying data collection and data sharing, and collecting complementary and integrative health information. Access the complete workshop materials and videocast recordings.
Panelists: Elizabeth Wick, Chandra Almond, Leslie Crofford; Moderator: Keith Marsolo
Session 4: Retrofitting, Reimagining, and Redesigning Health Care Systems to Reach Populations Most Affected by Health Inequities
Session 4 focused on approaches to ensuring that populations most affected by health inequities in the condition being studied are included in research. Panelists discussed how to ensure that healthcare systems in both resource-rich and underserved settings are research-ready to engage historically marginalized populations. Access the complete workshop materials and videocast recordings.
Panelists: Diana Burgess, Eduard Vasilevskis, Gloria Coronado; Moderator: Rosa Gonzalez-Guarda
Session 5: Overcoming Administrative Burden in Pragmatic Research
Session 5 explored ways to overcome administrative burdens in pragmatic research, including burdens associated with contracts, data use agreements, and institutional review board review and approval. Panelists with experience conducting NIH Collaboratory Trials shared lessons, successes, and failures. Access the complete workshop materials and videocast recordings.
Panelists: Karen Hartman, Geeta Swamy, Pearl O’Rourke, Keith Marsolo, Michael Kurilla, Michael Ho, Miguel Vazquez; Moderator: Adrian Hernandez