On April 20^th and 21^st, nearly 100 members of the NIH Pragmatic Trials Collaboratory met in Bethesda, Maryland, for the program’s annual Steering Committee Meeting. With 10 productive years of leading the way in embedded pragmatic clinical trials, the group had a lot to celebrate. Members led discussions on the history and evolution of pragmatic trials and shared thoughts for future priorities. In addition, leaders from five other pragmatic trial programs across the nation shared their experiences and lessons learned during a session entitled Looking at the Landscape of National ePCT Initiatives, which we recap here.

Anne Trontell, an Associate Director in the Clinical Effectiveness and Decision Science Program at the Patient-Centered Outcomes Research Institute (PCORI), spoke about PCORI’s experiences with pragmatic research initiatives. PCORI trials explore real-world decision-making about healthcare treatment options. Notable PCORI trials range in scope from asthma treatments for Black and Latinx Adults to comparative effectiveness trials of Aspirin dosing in cardiovascular disease (ADAPTABLE). Dr. Trontell stressed the value of relationships with diverse stakeholders before the start of a trial. This “prework” can help researchers better understand the issues facing research staff and participants as well as provide insight about the context, capacity, and resources available. See the slides from Dr. Trontell’s presentation for more information.

Robert Kerns, a Principal Investigator for the NIH-DoD-VA Pain Management Collaboratory Coordinating Center (PMC³), explained the intention of the program’s trials to inform future policy and practice regarding pain management in the VA or DOD. Dr. Kerns credits the PMC³ work groups, particularly the Biostatistics and Study Design Work Group, for the successful transition of their 11 trials to the implementation phase. PMC³ prioritized data harmonization among their trials. Use of common data collection measures and optimizing data collected from the EHR allows for easier data sharing and aggregation across projects. Building a community of trust among all stakeholders was key to the success of the projects. See slides from Dr. Kern’s presentation for more information.

Partha Bhattacharyya, Program Director for the National Institute on Aging and a lead developer of the National Institute on Aging IMbedded Pragmatic Alzheimer’s disease and AD-Related Dementias Clinical Trials (NIA IMPACT) Collaboratory, provided an overview of the project’s goals and accomplishments over the last 2 years. The NIA IMPACT Collaboratory supports the design and conduct of pragmatic trials for innovative dementia care. The program recognizes that understanding health system and patient experiences is essential for successful trials. Junior and senior investigators are recruited through a Faculty Scholars Program and embedded in the health systems to learn how the systems work. Stakeholders from healthcare systems and patient populations are also included in the process of developing research trials. See slides from Dr. Bhattacharyya’s presentation for more information.

Wendy Weber, Branch Chief for the NIH Clinical Research in Complementary and Integrative Health, introduced the NIH Helping to End Addiction Long-term (HEAL) Initiative. The program began in 2018 and provides $500 million dollars a year in funding for projects that enhance pain management or improve treatments for opioid misuse and addiction. The program has funded over 600 research projects and 26 programs including the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) program. The NIH Pragmatic Trials Collaboratory serves as the Resource Coordinating Center for PRISM. The PRISM trials focus on non-opioid interventions to manage pain and reduce reliance on opioids as well as identify effective strategies to implement evidence-based interventions. The HEAL Initiative aims to study pain and opioid use disorder as co-occurring conditions as well as promote health equity in research and treatment. See slides from Dr. Weber’s presentation for more information.

Gregory Simon, principal investigator of the Mental Health Research Network (MHRN), described the program’s mission to identify research questions that matter to stakeholders, find answers, and implement results for the benefit of real-world patients and providers. The MHRN began in 2010 and has now reached approximately 22 million patients in 14 health systems. Dr. Simon attributes the success of MHRN projects to longstanding, collaborative relationships with health plan and medical leaders, patient representatives, and IRBs. The project prioritizes the intersection of interests among patients, clinicians, health system leaders, and funders. See slides from Dr. Simon’s presentation for more information.

We will be sharing more insights form the 2022 NIH Pragmatic Trials Steering Committee Meeting over the coming weeks. All meeting materials are available online.