Drs. Beverly Green and Gloria Coronado and colleagues have published an article in Clinical Trialsdescribing the challenges of recruiting participants into large, multisite pragmatic clinical trials—particularly at the health system level. STOP CRC is one of the NIH Collaboratory’s pragmatic clinical trial Demonstration Projects, which are intended to provide a framework of implementation methods and best practices to enable participation of varied health care systems in clinical research.
STOP CRC is testing a culturally tailored, health care system–based program to improve colorectal cancer screening rates in a community-based collaborative network of federally qualified health centers. The authors observed that recruiting sites to participate in pragmatic trials is time-intensive and involves both preparing materials and organizing face-to-face meetings with staff and clinic leaders. Yet little is known about the characteristics of nonparticipating sites and clinic-level factors that may influence willingness to participate in a pragmatic trial.
“Our findings underscore the importance of assessing and reporting recruitment success at the organizational and/or clinic level in order to know the external validity of the findings and may inform future efforts to select and recruit health systems to participate in pragmatic research.” (Coronado, et al. Clin Trials 2015)
Few clinical trials are entirely explanatory (done in an idealized setting) or entirely pragmatic (done in a usual-care setting); rather, trials are situated somewhere along a continuum of applicability. Pragmatic clinical trials are trials designed with pragmatic qualities and are intended to inform decision makers, including patients, clinicians, administrators, and policymakers, about the relative benefits, burdens, and risks of a health intervention.
To help trialists assess how closely their trial’s design matches its intended purpose, a group of trialists and methodologists developed a design tool, the Pragmatic–Explanatory Continuum Indicator Summary, or PRECIS. Originally implemented in 2008, the wheel-shaped indicator tool recently underwent a revision, leading to PRECIS-2. The revised, validated tool guides trialists to prospectively consider the design of their trial along 9 domains: eligibility criteria, recruitment, setting, organization, flexibility (delivery), flexibility (adherence), follow-up, primary outcome, and primary analysis.
*Kirsty Loudon et al. BMJ 2015;350:bmj.h2147. Copyright 2015 by British Medical Journal Publishing Group. Used by permission.
“Ethics and Regulatory Complexities for Pragmatic Clinical Trials,” a Viewpoint article by Jeremy Sugarman, MD, MPH, MA, and Robert Califf, MD, was published online in JAMA today. In the article, the authors draw on early experiences from two large networks conducting pragmatic clinical trials, the NIH Collaboratory and the National Patient-Centered Clinical Research Network (PCORnet), to describe 10 ethical and regulatory complexities facing this new field of research. Topics covered include informed consent, risk determination, the role of gatekeepers, and institutional review board review and oversight, among others, as well as the ongoing need for further discussion and research as a key part of efforts aimed at creating a learning healthcare system.
Dr. Sugarman is chair of the Regulatory/Ethics Core of the NIH Collaboratory and deputy director for medicine of the Johns Hopkins Berman Institute of Bioethics. Dr. Califf is the principal investigator of the NIH Collaboratory Coordinating Center and director of the Duke Translational Medicine Institute.
Dr. Huang was one 10 winners of CRF Research Achievement Awards, which are presented annually. A key report related to the ABATE project was published in the New England Journal of Medicine in June of 2013.
Additional details of the award are available here.