The Grand Rounds session will be held on Friday, April 26, 2024, at 1:00 pm eastern.
Milner is a regulatory policy adviser in the FDA's Office of Clinical Policy. Casey is an assistant professor of medicine and the director of the coordinating center for the Pragmatic Critical Care Research Group at Vanderbilt University Medical Center. Semler is an associate professor of medicine and codirector of the Vanderbilt Center for Learning Healthcare at Vanderbilt University Medical Center.
In a new report from the NIH Pragmatic Trials Collaboratory, a team of bioethicists and implementation scientists argue for a “presumptive default” that the results of pragmatic clinical trials should be incorporated into healthcare delivery processes. This responsibility arises from a key rationale for conducting pragmatic trials: that they can facilitate uptake of their results by relevant decision-makers.
Much of the literature on posttrial responsibilities offers guidance on what is owed to research participants and broader communities at the conclusion of traditional explanatory clinical trials. Similar guidance is lacking for pragmatic trials.
The NIH Collaboratory researchers, led by Stephanie Morain of Johns Hopkins University, explore the distinct considerations that shape posttrial responsibilities in pragmatic trials. These include the responsibilities of the healthcare systems in which these trials are embedded, and decisions about implementation of interventions that show meaningful benefit after their integration into usual care settings, as well as deimplementation of those that do not.
Fulfilling this responsibility will require prospective planning by researchers, healthcare delivery system leaders, institutional review boards, and sponsors, so as to ensure that the knowledge gained from [pragmatic trials] does, in fact, influence real-world practice.
The article was coauthored by members of the NIH Collaboratory’s Ethics and Regulatory Core and Implementation Science Core, including Pearl O’Rourke, formerly of Partners HealthCare; Joseph Ali and Jeremy Sugarman of Johns Hopkins University; Vasiliki Rahimzadeh of the Baylor College of Medicine; and Devon Check and Hayden Bosworth of Duke University.
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. The 2017 revision of the Common Rule likewise sets out a requirement for sIRB review of cooperative research.
The new chapter on sIRBs in the Living Textbook covers:
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 Core, NIH staff, and NIH Collaboratory Coordinating Center personnel.
The goal of RAMP is to evaluate the use of a 12-week mind-body skills training program for patients with pain, including a one-on-one session with a “whole health coach” followed by 11 weekly group sessions to include prerecorded expert-led education videos, mind-body skills training and practice, and group discussions.
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 Regulatory Core, NIH staff, and NIH Collaboratory Coordinating Center personnel.
AIM-CP will address test a care management program to address inequities in access to nonpharmacological treatment for chronic pain in rural populations.
The MOMs Chat & Care Study will test the effectiveness of an integrated care model approach at 2 levels of intensity designed to facilitate timely, appropriate care for Black patients to reduce their risk for severe maternal morbidity.
Ethics and regulatory onboarding documentation is now available for iPATH, 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 Core, NIH staff, and NIH Collaboratory Coordinating Center personnel.
The goal of iPATH is to refine and implement an approach to practice transformation that was originally conceived and pilot-tested to support federally qualified health centers (FQHCs) in their pursuit of National Committee for Quality Assurance recognition as patient-centered medical homes for patients with type 2 diabetes. The study will include extensive qualitative work to identify implementation factors in FQHCs that are diverse in terms of geography, race/ethnicity, and diabetes control performance; and to customize and comprehensively evaluate the implementation approach.
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 Regulatory Core, NIH staff, and NIH Collaboratory Coordinating Center personnel. Both projects are in their planning phase.
ARBOR-Telehealth will evaluate the use of a telehealth physical therapy strategy for patients who present to primary care clinics with low back pain in rural communities. A secondary aim of the study is to compare the effectiveness of the study's risk-stratification approach.
I CAN DO Surgical ACP will identify a system-based approach to help older adults undergoing elective surgery engage in advance care planning. The project will leverage the existing electronic health record and patient portal, PREPARE for Your Care materials to assist patients with completion of advance care planning, virtual healthcare navigators, and electronic nudges. Another goal of the study is to understand digital engagement, language, and social drivers of health that drive engagement in the intervention.
The chapter provides guidance on responsible conduct of pragmatic clinical trial research involving artificial intelligence and machine learning, including navigating the institutional review board approval process, considerations for data procurement and consent, and choices regarding what data are procured and how they are used to build equity-enhancing algorithmic models.
The Stepped Wedge Cluster Randomized Trial: Friend or Foe?
Description
This Grand Rounds presentation was part of our special Grand Rounds series, Ethical & Regulatory Dimensions of Pragmatic Clinical Trials. Monica Taljaard and David Magnus present their lessons learned from using stepped-wedge designs in ePCTs.
Speakers
Monica Taljaard, PhD
Senior Scientist, Clinical Epidemiology Program, Ottawa Hospital Research Institute
Full Professor, Epidemiology and Community Medicine, University of Ottawa
David Magnus, PhD
Professor of Medicine and Biomedical Ethics and Professor of Pediatrics, Medicine, and by courtesy of Bioengineering
Director, Stanford Center for Biomedical Ethics
Associate Dean for Research
Responding (or Not) to Signals of Potential Clinical Significance in Pragmatic Clinical Trials
Description
This Grand Rounds presentation was part of our special Grand Rounds series, Ethical & Regulatory Dimensions of Pragmatic Clinical Trials. Joe Ali, Tanya Matthews, and Leslie Crofford discuss what to do when data in a pragmatic clinical trial includes information that might signal physical, mental health or behavioral health risks to patient-subjects (e.g. substance use, depression, anxiety, suicidality).
Speakers
Joseph Ali, JD
Assistant Professor, Dept. of International Health
Johns Hopkins Bloomberg School of Public Health
Core Faculty & Associate Director for Global Programs
Johns Hopkins Berman Institute of Bioethics
Leslie J. Crofford, MD
Wilson Family Chair in Medicine
Professor of Medicine and Pathology, Microbiology & Immunology
Chief, Division of Rheumatology
Vanderbilt University Medical Center