Rethinking Clinical Trials

MARCH 28, 2024

Dr. Rosa Gonzalez-Guarda The NIH Pragmatic Trials Collaboratory’s Health Equity Core developed a written aid to offer guidance on inclusive language and terms to use when referring to specific people, groups, and communities. The Equitable Language Cheat Sheet is available on the Health Equity Core webpage and will be updated as terminology and guidance evolves.

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MARCH 27, 2024

Drs. Amit Garg and Stephanie Dixon In this Friday’s PCT Grand Rounds, Amit Garg and Stephanie Dixon of Western University’s Schulich School of Medicine and Dentistry will present “Effect of a Multicomponent Intervention to Improve Patient Access to Kidney Transplant and Living Kidney Donation: A Pragmatic, Cluster-Randomized Trial.” The Grand Rounds session will be held on Friday, March 27, 2024, at 1:00 pm eastern.

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MARCH 25, 2024

The Patient-Centered Outcomes Research Institute (PCORI) announced the release of its new Foundational Expectations for Partnerships in Research. The resource is an update of the 2014 PCORI Engagement Rubric. It builds on a growing body of evidence about engaging patients and other partners in patient-centered comparative effectiveness research. A webinar on April 4 will explore the foundational expectations, which PCORI describes as “building blocks for meaningful, effective, and sustaina

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MARCH 21, 2024

The National Institute of Nursing Research (NINR) published a funding opportunity for research to improve health outcomes and advance health equity in rural populations. Rural populations experience high rates of many causes of morbidity and disability, and high and increasing rates of premature death. Meaningful and sustained improvements in the health of rural populations require effective solutions to address the underlying causes.

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MARCH 20, 2024

Dr. Warren Jones In this Friday’s PCT Grand Rounds, Warren Jones of Emory University will present “Early Diagnosis and Assessment of Autism via Objective Measurements of Social Visual Engagement.” The Grand Rounds session will be held on Friday, March 22, 2024, at 1:00 pm eastern. Jones is the director of research at the Marcus Autism Center and the Norman Nien Distinguished Chair in Autism and an associate professor of pediatrics at the Emory University School of Medicine.

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MARCH 14, 2024

The NIA IMPACT Collaboratory, a program to advance pragmatic clinical trials of interventions for people living with dementia and their care partners, announced a new collection of statistical tools for researchers. The tools are available on a new Statistical Tools webpage that will be updated as new resources become available. The program’s Design and Statistics Core developed the statistical tools and related resources to aid in the design and analyses of pragmatic trials embedded in he

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MARCH 13, 2024

Dr. Edward Qian In this Friday's PCT Grand Rounds, Edward Qian of Vanderbilt University will present "The Effect of Antibiotic Choice on Renal Outcomes: The ACORN Trial." The Grand Rounds session will be held on Friday, March 15, 2024, at 1:00 pm eastern. The ACORN trial compared the effects of cefepime vs piperacillin-tazobactam on the incidence of acute kidney injury among acutely ill adults.

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FEBRUARY 28, 2024

            Speakers Adrian Hernandez, MD Executive Director, Duke Clinical Research Institute Vice Dean, Duke University School of Medicine Christopher J. Lindsell, PhD Professor and co-Chief of Biostatistics, Department of Biostatistics & Bioinformatics Director, Data Science and Biostatistics, Duke Clinical Research Institute Duke University School of Medicine Editor in Chief, Journal of Clinical and translational Science Slides Keywords Decentralized Clinical Trials, Virtual

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FEBRUARY 28, 2024

In this Friday’s PCT Grand Rounds, Joseph Doyle of the Massachusetts Institute of Technology (MIT) will present “Effect of an Intensive Food-as-Medicine Program on Health and Healthcare Use: Evidence From a Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, March 1, 2024, at 1:00 pm eastern. Doyle is the Erwin H.

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FEBRUARY 27, 2024

The Health Care Systems Research Network (HCSRN) extended early-bird registration for its 2024 Annual Conference to February 29. The conference will be held from April 9 to 11 in Milwaukee, Wisconsin. New this year, a preconference grant writing workshop will take place on Monday, April 8. The workshop will bring together experts throughout HCSRN to assist early investigators with NIH R series applications.

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FEBRUARY 26, 2024

Dr. Oluwaseun Adeyemi, lead author of the report Communication skills training using the EM Talk model reached a high proportion of clinicians in participating emergency departments and improved their serious illness conversation skills, according to a qualitative study conducted as part of the PRIM-ER trial. The observed reach and effectiveness of the training program has the potential to improve use of these skills in clinical practice.

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FEBRUARY 22, 2024

An updated template from the NIH Pragmatic Trials Collaboratory provides guidance for the transparent reporting of the primary results of pragmatic clinical trials. The template includes elements from the Consolidated Standards of Reporting Trials (CONSORT) and its extensions. It also addresses secondary use of electronic health record data, involvement of research partners and healthcare systems in the conduct of pragmatic trials, and special ethical and regulatory considerations.

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FEBRUARY 21, 2024

In this Friday’s PCT Grand Rounds, Adrian Hernandez and Christopher Lindsell of Duke University will present “Virtual Vigilance: Monitoring of Decentralized Clinical Trials.” The Grand Rounds session will be held on Friday, February 23, 2024, at 1:00 pm eastern. Hernandez is the executive director of the Duke Clinical Research Institute (DCRI) and professor of medicine and vice dean in the Duke University School of Medicine.

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FEBRUARY 14, 2024

            Speaker Cynthia Hau, MPH Statistician Boston Cooperative Studies Program Coordinating Center VA Boston Healthcare System Slides Keywords Diuretic Comparison Project, VA Health System, Patient Recruitment, VA Point of Care Program Key Points Diuretic Comparison Project (DCP) was one of the first full-scale studies for the VA Point of Care Program.

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FEBRUARY 14, 2024

Dr. Jeffrey Carson In this Friday’s PCT Grand Rounds, Jeffrey Carson of Rutgers Biomedical and Health Sciences will present “Clinical Implications of the MINT Trial: p=0.07.” The Grand Rounds session will be held on Friday, February 16, 2024, at 1:00 pm eastern. Carson is provost-New Brunswick for Rutgers Biomedical and Health Sciences and the Distinguished Professor of Medicine and Richard C.

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FEBRUARY 13, 2024

Dr. Steven George The NIH Pragmatic Trials Collaboratory published a new chapter in its Living Textbook of Pragmatic Clinical Trials. The chapter, Patient Engagement , describes principles and strategies for effectively engaging patient partners. Because patients can provide valuable insights and perspectives about clinical care for specific conditions, they are key partners for pragmatic clinical trials.

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FEBRUARY 12, 2024

Dr. Steven George The NIH Pragmatic Trials Collaboratory published a new chapter in its Living Textbook of Pragmatic Clinical Trials. The chapter, Patient Engagement , describes principles and strategies for effectively engaging patient partners. Because patients can provide valuable insights and perspectives about clinical care for specific conditions, they are key partners for pragmatic clinical trials.

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FEBRUARY 8, 2024

The Health Care Systems Research Network (HCSRN) continued early-bird registration and announced the opening plenary speaker for its 2024 Annual Conference , which be held from April 9 to 11 in Milwaukee, Wisconsin. This year's opening plenary session will feature keynote speaker David Kent, director of the Tufts Predictive Analytics and Comparative Effectiveness Center and a professor of medicine, neurology, and clinical and translational science at Tufts Medical Center and Tufts University Sch

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FEBRUARY 7, 2024

In this Friday’s PCT Grand Rounds, Cynthia Hau of the VA Boston Health Care System will present “Pragmatic Recruitment of Underrepresented Groups: Experience From the Diuretic Comparison Project.” The Grand Rounds session will be held on Friday, February 9, 2024, at 1:00 pm eastern. Hau is a statistician for the VA Cooperative Studies Program Coordinating Center in the VA Boston Health Care System.

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FEBRUARY 7, 2024

            Speaker Susan C. Winckler, RPh, Esq Chief Executive Officer Reagan-Udall Foundation for the FDA Slides Keywords U.S. Food and Drug Administration, FDA, Misinformation, Communication, Health Information Key Points U.S. Food and Drug Administration (FDA) Commissioner Robert Califf asked the Reagan-Udall Foundation to conduct research and consult with experts to better understand how consumers find, consume, and perceive health information, especially regarding FDA-regulated

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FEBRUARY 6, 2024

Injury survivors from racial and ethnic minority groups experienced greater improvements than White injury survivors in their posttraumatic stress disorder (PTSD) symptoms after receiving a stepped collaborative care intervention. This was the finding of a secondary analysis of data from the Trauma Survivors Outcomes and Support (TSOS) study, an NIH Pragmatic Trials Collaboratory Trial.

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JANUARY 25, 2024

The NIH Pragmatic Trials Collaboratory this week published a new chapter in its Living Textbook of Pragmatic Clinical Trials. Part of the Living Textbook’s new ethics and regulatory collection, the chapter discusses the logistics of using a single IRB (sIRB). In 2016, the NIH issued a policy establishing the expectation that a “single IRB of record” will be used for all NIH-funded, multisite, human subjects research.

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JANUARY 24, 2024

In this Friday's PCT Grand Rounds, Suresh Balu and Marc Sendak of Duke University will present "Advancing the Safe, Effective, and Equitable Use of AI in Healthcare." The Grand Rounds session will be held on Friday, January 26, 2024, at 1:00 pm eastern. Balu is the director of the Duke Institute for Health Innovation (DIHI) and the associate dean for innovation and partnership in the Duke University School of Medicine.

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JANUARY 23, 2024

          Speaker Pamela S. Douglas, MD, MACC, FASE, FAHA Ursula Geller Professor of Research in Cardiovascular Diseases Duke Clinical Research Institute – Duke University Past President, American College of Cardiology Past President, American Society of Echocardiography Slides Keywords Chest Pain, Cardiovascular Imaging, Coronary Artery Disease Key Points Imaging has transformed cardiology and many other fields.

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JANUARY 23, 2024

Ethics and regulatory onboarding documentation is now available for RAMP, one of the NIH Pragmatic Trials Collaboratory's newest pragmatic clinical trials. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the study. The consultation took place by video conference and included representation from the study's principal investigator and study team, members of the NIH Collaboratory's Ethics and Regulatory

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JANUARY 22, 2024

What happens to a pragmatic trial intervention after the study ends? In a new article from the NIH Pragmatic Trials Collaboratory, investigators from 6 of the program's completed pragmatic clinical trials summarize the posttrial interpretation of their trials' results and consider the factors that influenced the sustainment or de-implementation of the studies' interventions.

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JANUARY 17, 2024

         Speaker Erin K. McCreary, PharmD, BCIDP Director of Infectious Diseases Improvement and Clinical Research Innovation, UPMC Clinical Assistant Professor of Medicine, University of Pittsburgh President-Elect, Society of Infectious Diseases Pharmacists (SIDP) Slides Keywords COVID-19, therapeutics, health equity, pragmatic clinical trial Key Points In April 2020, UPMC established a COVID Therapeutics Committee to determine a process for allocating experimental COVID-19 therapies.

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JANUARY 17, 2024

Dr. Pamela Douglas (Photo: Erin Roth, Duke Health) In this Friday's PCT Grand Rounds, Pamela Douglas of Duke University will present "Why Are Imaging RCTs Different? Lessons From Chest Pain Evaluation Trials." The Grand Rounds session will be held on Friday, January 19, 2024, at 1:00 pm eastern. Douglas is the Ursula Geller Professor of Research in Cardiovascular Diseases at Duke University and a past president of both the American College of Cardiology and the American Society of Echocardiograp

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JANUARY 16, 2024

Ethics and regulatory onboarding documentation for 2 of the NIH Pragmatic Trials Collaboratory's newest trials is now available. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the AIM-CP trial and the MOMs Chat & Care Study. The consultations took place by video conference and included representation from the studies' principal investigators, members of the NIH Collaboratory's Ethics and Regulat

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JANUARY 8, 2024

In a new article from the NIH Pragmatic Trials Collaboratory, investigators from 6 of the program’s pragmatic clinical trials share case examples of the challenges they encountered in collecting patient-reported outcomes (PROs) in their trials and the strategies they used to address them. The article was published this week in Contemporary Clinical Trials.

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JANUARY 3, 2024

In this Friday's PCT Grand Rounds, Rui Wang of Harvard Medical School will offer the final session in our special series, Advances in the Design and Analysis of Pragmatic Clinical Trials, with "Methods for Handling Missing Data in Cluster Randomized Trials." The session will be held on Friday, January 5, at 1:00 pm eastern. Wang is an associate professor of population medicine and the director of the Division of Biostatistics in the Department of Population Medicine at Harvard Medical School and

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JANUARY 2, 2024

The National Institute of Nursing Research (NINR) has published a funding opportunity for research to develop and expand interventions and programs that leverage existing or create new healthcare-community partnerships to address unmet social needs among individuals and families and adverse social determinants of health within communities—especially in populations that experience health disparities.

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DECEMBER 20, 2023

         Speaker Roxana Mehran, MD, FACC, FAHA, MSCAI, FESC Mount Sinai Endowed Professor of Cardiovascular Clinical Research and Outcomes Professor of Medicine (Cardiology), and Population Health Science and Policy Director, Interventional Cardiovascular Research and Clinical Trials Director, Women’s Heart and Vascular Center at Mount Sinai Heart Icahn School of Medicine at Mount Sinai Slides Keywords Cardiovascular Health, Interventional Cardiovascular Research, Diversity, Health Di

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DECEMBER 18, 2023

December 10, 2023 : The NIH Pragmatic Trials Collaboratory hosted a Workshop at the 2023 AcademyHealth 16th Annual Conference on the Science of Dissemination and Implementation in Health. This training workshop introduces concepts in the design, conduct, and implementation of embedded pragmatic clinical trials (ePCTs), and provides firsthand ePCT experiences and case studies from the NIH Pragmatic Trials Collaboratory Demonstration Projects.

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Rethinking Clinical Trials

DECEMBER 18, 2023

Ethics and regulatory onboarding documentation for 2 of the NIH Pragmatic Trials Collaboratory's newest trials is now available. The documents include meeting minutes and supplementary materials summarizing recent discussions of ethics and regulatory issues associated with the ARBOR-Telehealth and I CAN DO Surgical ACP studies. The consultations took place by video conference and included representation from the studies' principal investigators, members of the NIH Collaboratory's Ethics and Regu

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DECEMBER 13, 2023

In this Friday's PCT Grand Rounds, Roxana Mehran of the Icahn School of Medicine at Mount Sinai will present "Diversifying Clinical Trials: A Path Forward." The Grand Rounds session will be held on Friday, December 15, 2023, at 1:00 pm eastern. Mehran is a professor of medicine and the director of interventional cardiovascular research and clinical trials at the Zena and Michael A.

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DECEMBER 12, 2023

         Speakers Ruth Engelberg, PhD Research Professor of Medicine Division of Pulmonary, Critical Care and Sleep Medicine University of Washington Erin Kross, MD Associate Professor of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine University of Washington Robert Lee, MD, MS Assistant Professor of Medicine Division of Pulmonary, Critical Care and Sleep Medicine University of Washington Slides Keywords Jumpstart, Advanced Planning, Goals of Care Key Points Researche

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