The NIA IMPACT Collaboratory will publish new funding opportunities on August 15 for a pilot grants program and a NIH Collaboratory Trials program. The 1-year pilot grant awards will be eligible for funding of up to $175,000. The awards will support pilot projects that aim to generate preliminary data for the design and conduct of full-scale ...

In connection with the NIH Pragmatic Trials Collaboratory’s annual Steering Committee meeting and 10th anniversary celebration, we interviewed Dr. Christy Zigler and Dr. Emily O’Brien, asking them to reflect on the role of the Patient-Centered Outcomes Core in helping the NIH Collaboratory Trial teams plan and implement their trials, and to discuss their focus for ...

Respect for persons is a central obligation for the ethical conduct of research with human subjects. Traditionally, clinical trials have primarily relied on informed consent practices to fulfill this ethical obligation. A new article in the Hastings Center Report proposes 8 dimensions for how researchers can meet the ethical obligation of respect for persons in pragmatic ...

In this Friday’s COVID-19 Grand Rounds, Dr. Carolyn Bramante, Dr. Thomas Murray, and Dr. Jared Huling of the University of Minnesota will present “Results From the COVID-OUT Trial, a Phase-3 Trial of Outpatient Treatment for COVID-19 Using Metformin, Ivermectin, and Fluvoxamine.” The Grand Rounds session will be held on Friday, July 8, at 1:00 pm eastern. ...

In connection with the NIH Pragmatic Trials Collaboratory Steering Committee meeting and 10th anniversary celebration, we sat down for an interview with Drs. Karen Sherman and Lynn DeBar to get an update on the Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults (BackInAction) NIH Collaboratory Trial. BackInAction is a pragmatic randomized ...

Pragmatic clinical trials experienced significant impacts of COVID-19 on trial activities, according to a survey of NIH Pragmatic Trials Collaboratory Trials published last month in Trials. Since the beginning of the COVID-19 pandemic in March 2020, many of the NIH Collaboratory Trials have had to postpone recruitment, alter methods of participant engagement, and modify tools for ...

Implementation of a user-centered clinical decision support tool did not increase the rate of patients receiving buprenorphine for treatment of opioid use disorder in the emergency department (ED) when compared to usual care. When the tool was used, it was associated with high rates of buprenorphine initiation, and the tool increased the number of physicians who ...

A special series of articles addressing pragmatic and virtual trials appears this week in the journal Contemporary Clinical Trials and offers practical approaches to the many challenges clinical trials face. The 14 articles bring together leaders, researchers, biostatisticians, and bioethicists—including members of the NIH Pragmatic Trials Collaboratory—who are rethinking key aspects of the development, conduct, and ...

In an interview at the NIH Pragmatic Trials Collaboratory’s annual Steering Committee meeting and 10th anniversary celebration, we asked Drs. Jeremy Sugarman and Pearl O’Rourke to discuss the role of the Ethics and Regulatory Core in helping the NIH Collaboratory Trial teams plan and implement their pragmatic trials, and the contributions the Core has made ...

In this Friday’s PCT Grand Rounds, Dr. John Concato of the US Food and Drug Administration will present “FDA Draft Guidance on Real-World Evidence.” The Grand Rounds session will be held on Friday, June 24, 2022, at 1:00 pm eastern. Dr. Concato is the associate director for real-world evidence analytics in the Office of Medical Policy ...

ICD-Pieces, an NIH Pragmatic Trials Collaboratory NIH Collaboratory Trial, aims to improve care for patients with a triad of co-existing conditions: chronic kidney disease, diabetes, and hypertension. Dr. Miguel Vazquez, principal investigator of the ICD-Pieces project, discussed the study in an interview after the NIH Collaboratory’s annual Steering Committee meeting.      ICD-Pieces uses a novel information technology ...

In this Friday’s PCT Grand Rounds, Dr. Elliot Israel of Harvard Medical School will present “PREPARE: A Successful, Primarily Remote Pragmatic Trial in a Black and Latinx Population With Asthma: Challenges and Successes.” The Grand Rounds session will be held on Friday, June 17, 2022, at 1:00 pm eastern. Dr. Israel is a professor of medicine ...

The National Institute on Aging (NIA) Imbedded Pragmatic Alzheimer’s Disease (AD) and AD-Related Dementias (AD/ADRD) Clinical Trials (IMPACT) Collaboratory is now accepting applications for its Career Development Award (CDA) program. These CDAs support the development of MD, PhD, or equivalent researchers who seek careers conducting embedded pragmatic clinical trials (ePCTs) for people living with AD/ADRD ...

In an interview at the NIH Pragmatic Trials Collaboratory Steering Committee meeting in April, Drs. Rosa Gonzalez-Guarda, Rachel Gold, and Karen A. Kehl discussed the importance of including diverse participants in pragmatic clinical trials and the challenges investigators and community health centers face engaging underrepresented populations in research.  During the discussion, Gonzalez-Guarda, Gold, and Kehl identified ...

In an interview at the NIH Pragmatic Trials Collaboratory Steering Committee meeting and 10th anniversary celebration, we asked Drs. Sheana Bull and Michael Ho to update us on the Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge) NIH Collaboratory Trial. Nudge is using population-level pharmacy data to deliver nudges ...

In an interview at the NIH Pragmatic Trials Collaboratory Steering Committee’s annual meeting in April, Dr. Steven George discussed how to successfully implement an intervention in a pragmatic clinical trial and how intervention complexity affects implementation across various sites with different local contexts. “Variation is everywhere, and you have to be willing to ride that wave. ...

The NIH Pragmatic Trials Collaboratory will hold a virtual workshop over 2 half-days on June 15-16, 2022, to explore questions critical to designing and implementing pragmatic clinical trials (PCTs) conducted within health care systems. The NIH Pragmatic Trials Collaboratory has now been supporting pragmatic trials for a decade, including a set of trials in the PRISM ...

In this Friday’s PCT Grand Rounds, Dr. Tariq Ahmad of Yale University will present “Do We Really Need So Many Heart Failure Clinicians?” The Grand Rounds session will be held on Friday, June 10, 2022, at 1:00 pm eastern. Dr. Ahmad is the medical director of heart transplantation and mechanical circulatory support and chief of heart ...

The NIH Pragmatic Trials Collaboratory Heath Care Systems Interactions Core supports and facilitates productive collaboration between researchers, clinicians, and health system leaders to conduct effective, relevant embedded pragmatic clinical research. Health Care Systems Interactions Core Co-Chairs Dr. Eric B. Larson and Dr. Gregory Simon discussed the Core’s progress over the last 10 years in an interview ...

In an interview at the NIH Pragmatic Trials Collaboratory Steering Committee’s annual meeting in April, Dr. Stephanie Morain shared information about a bioethics supplement designed to explore the ethical issues that arise in the context of pragmatic clinical trials (PCTs) and data sharing.   “Our goal with the supplement is to identify the ways in which existing ...

In this Friday’s PCT Grand Rounds, Dr. Emily McDonald of McGill University will present “Results of the MedSafer Study: Electronic Decision Support for Deprescribing in Hospitalized Older Adults.” The Grand Rounds session will be held on Friday, June 3, 2022, at 1:00 pm eastern. The MedSafer study was a cluster randomized clinical trial evaluating the effects ...

GGC4H, an NIH Pragmatic Trials Collaboratory Trial, uses the RE-AIM framework to test the feasibility and effectiveness of implementing a guidance curriculum for parents to address problems common to early adolescents. Dr. Margaret Kuklinski, Co-PI of the GGC4H project, discussed the study in an interview for the NIH Collaboratory’s annual Steering Committee meeting.      “GGC4H is a ...

NOHARM, an NIH Pragmatic Trials Collaboratory Trial, is a cluster-randomized, stepped-wedge trial of a bundled intervention that relies heavily on the electronic health record to encourage perioperative patients to consider using nonpharmacologic approaches to manage their postoperative pain. The goal is to diminish patients’ reliance on opioids after surgery and, as a result, reduce rates ...

FM-TIPS, an NIH Collaboratory Trial, is studying real-world implementation of transcutaneous electrical nerve stimulation (TENS) therapy along with physical therapy to treat patients with fibromyalgia. Dr. Kathleen Sluka, Co-PI of the FM-TIPS project, and Dr. Emine Bayman, biostatistician for the project, discussed the study in an interview after the NIH Collaboratory’s annual steering committee meeting.      Sluka ...

Over the last 10 years, the Patient-Centered Outcomes Research Trust Fund (OS-PCORTF) has brought together agencies to work on joint problems and made data investments to enable research that generates knowledge about patient-centered outcomes. Nancy DeLew, MA, MPA, Associate Deputy Assistant Secretary for Health Policy in the Office of the Assistant Secretary for Planning and Evaluation ...

The NIH Pragmatic Trials Collaboratory will hold a virtual workshop over 2 half-days on June 15-16, 2022, to explore questions critical to designing and implementing pragmatic clinical trials (PCTs) conducted within health care systems. The NIH Pragmatic Trials Collaboratory has now been supporting pragmatic trials for a decade, including a set of trials in the PRISM ...

The National Institute of Child Health and Human Development (NICHD) recently released a request for information (RFI) to identify priority needs in pediatric therapeutics. “The purpose of this RFI is to obtain knowledge and gather information regarding current gaps in pediatric therapeutics.” Specifically, the NICHD is requesting nominations for drugs and therapeutic areas (e.g., pediatric condition, subpopulation, ...

In this Friday’s COVID-19 Grand Rounds, Dr. Upinder Singh of Stanford University will present “Long-COVID Studies Within the RECOVER Platform.” The Grand Rounds session will be held on Friday, May 20, at 1:00 pm eastern. The National Institutes of Health (NIH) created the RECOVER (Researching COVID to Enhance Recovery) Initiative to learn about the long-term ...

In an interview at the NIH Pragmatic Trials Collaboratory Steering Committee’s annual meeting in April, Dr. Rebecca Baker, Dr. Adrian Hernandez, and Dr. Wendy Weber discussed how the PRISM program and the NIH HEAL Initiative are working together to answer questions about pain management and the national opioid public health crisis.  Baker is the director of ...

In an interview at the NIH Pragmatic Trials Collaboratory Steering Committee’s annual meeting in April, Dr. Lesley Curtis, Dr. Adrian Hernandez, and Dr. Kevin Weinfurt discussed the program’s plans for the future. “The NIH Pragmatic Trials Collaboratory is developing the fundamental knowledge necessary to build a learning health care system,” said Hernandez. “The Collaboratory is learning ...

The NIH Pragmatic Trials Collaboratory is pleased to announce a new training workshop now available on the ePCT Training Workshop webpage. On April 11, 2022, the NIH Pragmatic Trials Collaboratory hosted a Pre-Conference Workshop, Essentials of Embedded Pragmatic Clinical Trials, at the 2022 Health Care Systems Research Network (HCSRN) Annual Conference. This training workshop introduces concepts in the design, conduct, ...

In an interview at the Steering Committee’s annual meeting in April, Dr. Wendy Weber, Dr. Josephine Briggs, and Dr. Catherine Meyers celebrate the success of the NIH Pragmatic Trials Collaboratory and look at the roadmap to its future.  In the Beginning… The NIH Pragmatic Trials Collaboratory (then the NIH Health Care Systems Research Collaboratory) began as an ...

In this Friday’s PCT Grand Rounds, Dr. Jeremy Sugarman, Dr. Stephanie Morain, and Juli Bollinger of Johns Hopkins University and Dr. Kevin Weinfurt of Duke University will present “Ethics and Collateral Findings in Pragmatic Clinical Trials: Implications of a Multi-Method Exploration.” The Grand Rounds session will be held on Friday, May 13, at 1:00 pm ...

In an interview at the NIH Pragmatic Trials Collaboratory Steering Committee’s annual meeting in April, Dr. Emily O’Brien and Dr. Adrian Hernandez discussed challenges for pragmatic trials during the COVID-19 pandemic and lessons for the future of the healthcare system. “We certainly did see some degree of disruption, but I was impressed by the flexibility in ...

The NIH Pragmatic Trials Collaboratory is partnering with AcademyHealth to offer a full-day pre-conference workshop at the 2022 Annual Research Meeting in Washington, DC. The workshop, “Essentials of Embedded Pragmatic Clinical Trials (ePCTs)”, will provide an introduction to investigative opportunities for embedded healthcare systems research, along with strategies for conducting clinical trials that provide real-world evidence ...

FDA leaders Dr. John Concato and Dr. Jacqueline Corrigan-Curay published a perspective piece in the New England Journal of Medicine encouraging researchers to be more explicit and specific about the types of real-world data (RWD) they are using to generate real-world evidence (RWE). The article, “Real-World Evidence — Where Are We Now?,” cautions that the terms ...

On April 20th and 21st, 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 ...

In a guest editorial in the American Journal of Bioethics, members of the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core introduced the issue’s target article and peer commentaries on artificial intelligence and machine learning in healthcare. Prof. Kayte Spector-Bagdady and Drs. Vasiliki Rahimzadeh and Kaitlyn Jaffe, who are Core members, were joined by coauthor ...

In this Friday’s PCT Grand Rounds, Dr. Gregory Marcus of the University of California, San Francisco, will present “n-of-1 Randomized Trials: CRAVE and I-STOP-AFib as Examples.” The Grand Rounds session will be held on Friday, May 6, at 1:00 pm eastern. The CRAVE trial investigated the real-time effects of caffeine intake on atrial and ventricular ectopy. ...

In a keynote speech at the NIH Pragmatic Trials Collaboratory Steering Committee annual meeting, FDA Commissioner Dr. Rob Califf called for more and faster evidence generation. “We have to generate evidence more quickly and then insist that it gets used,” he said. After his remarks, Califf joined Dr. Wendy Weber of the National Center for Complementary ...

The NIH Pragmatic Trials Collaboratory is partnering with AcademyHealth to offer a full-day pre-conference workshop at the 2022 Annual Research Meeting in Washington, DC. The workshop, “Essentials of Embedded Pragmatic Clinical Trials (ePCTs)”, will provide an introduction to investigative opportunities for embedded healthcare systems research, along with strategies for conducting clinical trials that provide real-world ...

In this Friday’s PCT Grand Rounds, Dr. Mark Pletcher of the University of California, San Francisco, Dr. Rhonda Cooper-DeHoff of the University of Florida, and Dr. Alanna Chamberlain of the Mayo Clinic will present “BP Track: National Surveillance for Blood Pressure Control and Related Process Metrics Using PCORnet.” The Grand Rounds session will be held ...

In this Friday’s PCT Grand Rounds, Dr. Dylan Steen and Dr. Sarah Couch of the University of Cincinnati will present “Development of a Novel Research Collaboration With the Retail Industry” The Grand Rounds session will be held on Friday, April 22, at 1:00 pm eastern. Dr. Steen, who is also the CEO of High Enroll LLC, ...

The US Food and Drug Administration (FDA) issued draft guidance yesterday recommending clinical trial sponsors develop a “Race and Ethnicity Diversity Plan” to ensure representative enrollment of racially and ethnically diverse participants in clinical trials developing medical products. The draft guidance, Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical ...

In this Friday’s PCT Grand Rounds, Dr. Justin Ezekowitz of University of Alberta will present “SODIUM-HF: Should Our Patients Consume Less Dietary Sodium?” The Grand Rounds session will be held on Friday, April 15, at 1:00 pm eastern. The SODIUM-HF trial is open-label, randomized controlled trial conducted at 26 sites in Australia, Canada, Chile, Colombia, Mexico, ...

The Trauma Survivors Outcomes and Support (TSOS) trial, an NIH Pragmatic Trials Collaboratory Trial, successfully implemented a large-scale suicide assessment and monitoring method in a pragmatic clinical trial focused on collaborative mental healthcare for traumatic injury survivors. Study intervention and monitoring methods are detailed in a recent publication in Psychiatry. TSOS researchers analyzed data collected at ...

In this Friday’s COVID-19 Grand Rounds session, Dr. Jason Block of Harvard Medical School and Dr. Thomas Carton of the Louisiana Public Health Institute will present “COVID-19 Surveillance in PCORnet: Year 2 Update.” The Grand Rounds session will be held on Friday, April 8, at 1:00 pm eastern. Join the online meeting. The NIH Pragmatic Trials Collaboratory ...

A downloadable study snapshot and updated ethics and regulatory documentation are now available for the GRACE trial, an NIH Pragmatic Trials Collaboratory Trial. GRACE transitioned from the planning phase to the implementation phase in September. As part of the transition, the study team reviewed and updated the minutes of their initial consultation with the Ethics and ...

In a new article from the NIH Pragmatic Trials Collaboratory Biostatistics and Study Design Core, the authors share analytic considerations for cluster randomized trials with hierarchical nesting of participants within clusters. The authors illustrate the problem using theoretical derivations, a simulation study, and data from the STOP CRC NIH Collaboratory Trial as an example. “We conclude ...

In this Friday’s PCT Grand Rounds, researchers from ICD-Pieces, an NIH Pragmatic Trials Collaboratory Trial, will present aggregate outcomes from the study and share experiences from trial implementation. Dr. Miguel Vazquez of the University of Texas Southwestern Medical Center and Dr. George (Holt) Oliver of the Parkland Center for Clinical Innovation will present “ICD-Pieces: Improving Care for ...