In a new episode of the Rethinking Clinical Trials Podcast, Greg Simon and Lorella Palazzo discuss key takeaways from the new End-of-Trial Decision-Making chapter of the Living Textbook. Listen to the podcast. For alerts about new episodes, subscribe for free on Spotify, Amazon Music, Apple Podcasts, or SoundCloud. The chapter provides guidance on how to navigate the hiatus between the end of ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Denise van Hout of University Medical Center Utrecht will present “Hurdles for the Delivery of Trials: Insights From the Randomized Embedded Multifactorial Adaptive Platform Trial on Community-Acquired Pneumonia (REMAP-CAP) in Europe.” The Grand Rounds session will be held on Friday, September 19, 2025, at 1:00 pm eastern. van Hout ...

The NIH Pragmatic Trials Collaboratory will hold a virtual workshop on November 4 and 5, 2025, on “Digging Into Dilemmas of Pragmatic Clinical Trials.” David Zaas, president of Atrium Health Wake Forest Baptist, will deliver a keynote presentation describing the state of healthcare delivery in the United States and the constraints on healthcare systems that ...

Older patients with chronic low back pain who receive acupuncture treatment have greater improvements in pain and disability compared with patients who receive usual care alone, according to the BackInAction trial. The results of the study were published online in JAMA Network Open. BackInAction, an NIH Collaboratory Trial, compared standard and enhanced courses of acupuncture with usual ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Natalia Morone, Carol Greco, and Kim Faurot will present “Initial Outcomes of the Optimizing Pain Treatment in Medical Settings Using Mindfulness (OPTIMUM) Pragmatic Trial.” The Grand Rounds session will be held on Friday, September 12, 2025, at 1:00 pm eastern. OPTIMUM, an NIH Collaboratory Trial, is studying the addition ...

In a descriptive analysis of the study population in the BackInAction trial, researchers found that participants enrolled from federally qualified health centers (FQHCs) had higher than average clinical and social risks at baseline, potentially complicating intervention delivery for these patients while adding to the generalizability of the trial’s results. The report was published in Contemporary Clinical ...

In a special session of Rethinking Clinical Trials Grand Rounds on September 26, longtime leaders from the NIH Pragmatic Trials Collaboratory will present “Significance in Pragmatic Clinical Trials: P Values vs Decision-Maker Perspectives.” The Grand Rounds session will be held on Friday, September 26, 2025, at 1:00 pm eastern. Greg Simon is a senior investigator at the ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Robert Califf of Duke University will present “The Non-Learning Health System.” The Grand Rounds session will be held on Friday, September 5, 2025, at 1:00 pm eastern. As a former US commissioner of food and drugs, Califf led the Food and Drug Administration from 2016 to 2017 and again ...

In a special session of Rethinking Clinical Trials Grand Rounds on September 5, special guest Dr. Robert Califf will present “The Non-Learning Health System.” The Grand Rounds session will be held on Friday, September 5, 2025, at 1:00 pm eastern. As a former US commissioner of food and drugs, Califf led the Food and Drug Administration from ...

At the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, researchers discussed the obligations pragmatic trials researchers have to research participants, partnering healthcare systems, and each other after a trial is complete. Panelists for the session included moderators Pearl O’Rourke and Jeremy Sugarman, cochairs of the NIH Collaboratory’s Ethics and Regulatory Core; Stephanie Morain, also ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Emily O’Brien of Duke University will present “The PCORnet Playbook: Avoiding the Fumble in Pragmatic Trials.” The Grand Rounds session will be held on Friday, August 22, 2025, at 1:00 pm eastern. O’Brien is an associate professor in population health sciences at Duke University. She serves as cochair of ...

A new analysis from the INSPIRE research team found that automated prompts to improve judicious use of antibiotics for hospitalized patients led to sustained reductions in the use of extended-spectrum antibiotics. The findings were reported in a research letter in JAMA. INSPIRE, an NIH Collaboratory Trial, consisted of 2 cluster randomized trials that used personalized clinical decision ...

Does a higher or lower target for phosphate control offer the best balance of benefits and risks in patients receiving maintenance hemodialysis? This important question remains unanswered, after the HiLo research team reported on the challenges that led to early termination of their innovative pragmatic clinical trial. The article was published online ahead of print in ...

In a new episode of the Rethinking Clinical Trials Podcast, Pearl O’Rourke and Dave Wendler discuss their recent publication, “Disentangling Informing Participants From Obtaining Their Consent.” Listen and subscribe to the podcast on Spotify, Amazon Music, Apple Podcasts, or SoundCloud. O’Rourke and Wendler noted that IRBs will often assume nothing needs to be communicated to participants in trials that ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Tim Walsh, Chris Weir, and Richard Parker of the University of Edinburgh will present “Dexmedetomidine or Clonidine-Based Sedation Compared With Propofol in Critically Ill Patients: The A2B Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, August 15, 2025, at 1:00 pm eastern. Walsh is professor ...

The NIH Pragmatic Trials Collaboratory Implementation Science Core, led by Devon Check and Hayden Bosworth, has developed a new chapter on implementation to assist study teams with the complex process of using and studying implementation strategies to help implement research findings into clinical care. The chapter includes sections on: Factors Influencing Implementation of PCT Results Incorporating Implementation ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Eden Evins of Harvard Medical School will present “Varenicline for Youth Nicotine Vaping Cessation: A Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, August 8, 2025, at 1:00 pm eastern. Evins is the Cox Family Professor of Psychiatry in the Field of Addiction Medicine and ...

In a special session of Rethinking Clinical Trials Grand Rounds on September 5, special guest Dr. Robert Califf will present “The Non-Learning Health System.” The Grand Rounds session will be held on Friday, September 5, 2025, at 1:00 pm eastern. As a former US commissioner of food and drugs, Califf led the Food and Drug Administration from ...

PTJ: Physical Therapy & Rehabilitation Journal (PTJ) is soliciting manuscript proposals for a special issue on embedded clinical research relevant to physical therapy and rehabilitation science. Proposals are due no later than September 1, 2025, and the special issue is scheduled for publication in 2026. From the announcement: Embedded Clinical Research: Pragmatic Trials, Big Data, and Beyond Traditionally, ...

Pragmatic clinical trials are conducted as part of routine healthcare delivery and often compare an intervention to usual care. To do this, researchers must understand, monitor, and document standard care at participating research sites. At the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, Duke University’s Emily O’Brian asked a panel of trialists about the ...

In a new episode of the NIH Pragmatic Trials Collaboratory Podcast, Lesley Curtis and Keith Marsolo of the NIH Pragmatic Trials Collaboratory discuss the latest Living Textbook learning module, “Healthcare Data Interoperability and Standardization for Research.” Listen and subscribe to the podcast on SoundCloud or Apple Podcasts. Curtis and Marsolo developed the module to help researchers understand how healthcare data ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Kenneth Kehl of the Dana-Farber Cancer Institute will present “Clinical Trial Notifications Triggered by Artificial Intelligence–Detected Cancer Progression.” The Grand Rounds session will be held on Friday, August 1, 2025, at 1:00 pm eastern. Kehl is a physician and associate director of research at the Dana-Farber Cancer Institute and ...

At the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, Angelo Volandes, co–principal investigator (PI) of the ACP PEACE trial, led a panel of investigators who shared key challenges and lessons learned from their recently launched trials. The panelists included Stephanie Fitzpatrick, PI of the MOMs Chat & Care Study, Elizabeth Wick, co-PI of ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Jon Tilburt of the Mayo Clinic in Arizona and Andrea Cheville of the Mayo Clinic in Minnesota will present “Initial Outcomes of the NOHARM Pragmatic Trial.” The Grand Rounds session will be held on Friday, July 25, 2025, at 1:00 pm eastern. NOHARM, an NIH Collaboratory Trial, is testing ...

At the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, a team of experts shared key decisions about whether or not to integrate digital tools into the electronic health record (EHR). The panel, moderated by Steve George of the NIH Collaboratory Coordinating Center, explained that the decision hinges on 4 critical factors: complexity, institutional ...

The Health Care Systems Research Network (HCSRN) will hold its 2026 Annual Conference from April 21 to 23, 2026, in Dallas, Texas. HCSRN is a 20-member research network focused on supporting research institutes aligned with healthcare delivery systems. HCSRN’s mission is to improve individual and population health through research that connects the resources and capabilities of ...

Features of the external environment during online medical group visits and interacting with the technology itself emerged as key themes in interviews with patients participating in the OPTIMUM trial. The findings were published online in Global Advances in Integrative Medicine and Health. OPTIMUM, an NIH Collaboratory Trial led by Natalia Morone of Boston University and Boston Medical Center, is ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Adrian Hernandez and Rebecca Sullenger of Duke University will present “State of Clinical Trials: An Analysis of ClinicalTrials.gov.” They will be joined by a discussion panel that will include Sara Bristol Calvert of the Clinical Trials Transformation Initiative (CTTI) and Karen Chiswell and Christopher J. Lindsell of Duke ...

Engaging with community partners can enrich and inform research through the lifespan of a trial. In a session at the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, Cherise Harrington, cochair of the program’s Community Health Improvement Core, led a discussion about building relationships with communities in pragmatic research. The panelists included Jennifer Kawi, principal ...

The P value is a statistic frequently used in biomedical research for the presentation of study findings. It represents a dichotomous decision about whether a finding is “statistically significant” based on a predetermined level, typically  < .05. Although the peer-reviewed journals in which researchers aspire to publish their work are anchored to P values, the information used ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Tyler Cope and Trevor Lentz of the Duke Clinical Research Institute will present “Novel Approaches to Recruiting Clinical Sites for Embedded Pragmatic Clinical Trials: Insights From the AIM-back Trial.” The live webinar will be held on Friday, July 11, 2025, at 1:00 pm eastern. Cope is a clinical research ...

In an analysis of data on seriously ill older adults from emergency departments that participated in the PRIM-ER trial, poor prognosis was associated with fewer healthy days at home. However, a cancer diagnosis was associated with more healthy days at home. The analysis was published online this month in BMC Geriatrics. PRIM-ER, an NIH Collaboratory Trial, was ...

PTJ: Physical Therapy & Rehabilitation Journal (PTJ) is soliciting manuscript proposals for a special issue on embedded clinical research relevant to physical therapy and rehabilitation science. Proposals are due no later than September 1, 2025, and the special issue is scheduled for publication in 2026. From the announcement: Embedded Clinical Research: Pragmatic Trials, Big Data, and Beyond Traditionally, ...

Trust in their clinicians, positive interactions with study staff, and opportunities for social connection can improve recruitment, retention, and engagement with research participants, according to focus groups of participants in the OPTIMUM trial. These factors can be especially important for first-time research participants and for groups that are historically underrepresented in clinical trials. The article was published ...

Although the need for pragmatic research in primary care settings is great, conduct of pragmatic clinical trials in these settings remains nascent. In a session at the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, Wendy Weber of the National Center for Complementary and Integrative Health (NCCIH) led a discussion about how to expand ...

A key feature of the NIH Pragmatic Trials Collaboratory is its culture of learning and knowledge sharing among investigators who are planning and conducting pragmatic clinical trials. In a session at the program’s 2025 Annual Steering Committee Meeting, a panel of investigators discussed their recently completed NIH Collaboratory Trials and their thoughts about future directions ...

In a new episode of the NIH Pragmatic Trials Collaboratory Podcast, Rich Platt, Hayden Bosworth, and Greg Simon of the NIH Pragmatic Trials Collaboratory discuss their JAMA Viewpoint, “Making Pragmatic Clinical Trials More Pragmatic.” Listen and subscribe to the podcast on SoundCloud or Apple Podcasts. In the Viewpoint, the authors propose solutions to the discordance between the results of pragmatic trials ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Amrita Mukhopadhyay of the NYU Grossman School of Medicine will present “The BETTER CARE-HF Study: A Pragmatic Cluster Randomized Trial to Improve Heart Failure Care.” The live webinar will be held on Friday, June 27, 2025, at 1:00 pm eastern. Mukhopadhyay is the Eugene Braunwald, MD, Assistant Professor of ...

The study design paper for ARBOR-Telehealth has been published online in BMJ Open. Congratulations to the study team on reaching this important milestone for all NIH Collaboratory Trials! The ARBOR-Telehealth study is evaluating the use of a telehealth physical therapy strategy for patients who present to primary care clinics with low back pain in rural communities. ...

A new section of the Living Textbook of Pragmatic Clinical Trials describes considerations for choosing patient-reported outcome measures in pragmatic clinical trials. “Where possible, investigators are encouraged to use measures with adequate support for validity that are in the public domain,” the authors wrote. The authors provide a set of questions to guide investigators in choosing appropriate ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Scott Garrison of the University of Alberta will present “The BedMed and BedMed-Frail Randomized Trials.” The trials compared bedtime vs morning administration of antihypertensive medications. The live webinar will be held on Friday, June 20, 2025, at 1:00 pm eastern. Garrison is a professor of family medicine at the ...

The NIH Pragmatic Trials Collaboratory held its 2025 Annual Steering Committee Meeting in Bethesda, Maryland, on May 28 and 29. The program’s leadership discussed evolving approaches to pragmatic clinical trials and considered the latest developments in the landscape of pragmatic research. All materials from the meeting are now available online. The NIH Pragmatic Trials Collaboratory added 3 ...

A new chapter of the Living Textbook of Pragmatic Clinical Trials describes regulatory requirements for informed consent, waivers and alterations of consent, mechanisms for notification, and research participants’ perspectives on a variety of approaches to consent and notification—all with a focus on special considerations for pragmatic clinical trials. For a variety of reasons, the  application of ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Stephanie Morain, Nancy Kass, and Ruth Faden will present “Fit for Purpose: Improving the Ethical Oversight of Pragmatic Clinical Trials.” The live webinar will be held on Friday, June 13, 2025, at 1:00 pm eastern. Morain is an associate professor of health policy and management in the Bloomberg School ...

The Health Care Systems Research Network (HCSRN) will hold its 2026 Annual Conference from April 21 to 23, 2026, in Dallas, Texas. HCSRN is a 20-member research network focused on supporting research institutes aligned with healthcare delivery systems. HCSRN’s mission is to improve individual and population health through research that connects the resources and capabilities of ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Jonathan Casey of Vanderbilt University Medical Center will present “The REDCap Advanced Randomization Module: A Trial Innovation Network Project to Support the Needs of Modern Trials.” The live webinar will be held on Friday, June 7, 2025, at 1:00 pm eastern. Casey is an assistant professor of medicine, a ...

In an evaluation conducted alongside the GGC4H trial, researchers assessed the intervention fidelity of a version of the Guiding Good Choices parenting program that was adapted for online delivery. They found that virtual delivery of the intervention was feasible but that retention of participants was a challenge. The report was published in the Journal of Community ...

In this Friday’s Rethinking Clinical Trials Grand Rounds, Ankeet Bhatt of the Kaiser Permanente Northern California Division of Research will present “Embedding Randomization Into Clinical Care in Learning Healthcare Systems: Insights From the KP-VACCINATE Megatrial.” The Grand Rounds session will be held on Friday, May 30, 2025, at 1:00 pm eastern. Bhatt is a cardiologist at the ...

The NIH Pragmatic Trials Collaboratory has launched a new learning module, Healthcare Data Interoperability and Standardization for Research, exploring the complexities of collecting, storing, and transforming healthcare data in the electronic health record to achieve optimal patient and research outcomes. The learning module, which was developed by members of the NIH Collaboratory’s Electronic Health Records Core ...

In a new episode of our Rethinking Clinical Trials Podcast, Drs. Angelo Volandes and James Tulsky speak with host Dr. Adrian Hernandez about the results of the ACP PEACE study. Listen and subscribe to the podcast on SoundCloud or Apple Podcasts. ACP PEACE, an NIH Collaboratory Trial, was a stepped-wedge, cluster randomized trial testing the delivery of a video decision ...