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Ethics and Regulatory Complexities for Pragmatic Clinical Trials

Jeremy Sugarman, MD, MPH, MA1,2; Robert M. Califf, MD3,4
[+] Author Affiliations
1Berman Institute of Bioethics, Johns Hopkins University, Baltimore, Maryland
2Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland
3Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina
4Duke Translational Medicine Institute, Duke University, Durham, North Carolina
JAMA. 2014;311(23):2381-2382. doi:10.1001/jama.2014.4164.
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Some patients do not receive the best care possible, either because research to support clinical decision making with high-quality evidence is lacking or because evidence-based practices are not routinely implemented.1 Pragmatic clinical trials (PCTs), which include patients in routine clinical practice settings and typically incorporate comparative effectiveness research (CER)—that is, comparing the safety and effectiveness of diagnostic, therapeutic, or delivery system options—can help overcome these challenges. The advent of research methods that use cluster randomization and leverage patient data from electronic health records (EHRs) to increase the sample size of trials at much lower costs is enabling major national initiatives to generate the data needed to improve care. These include the Health Care Systems Research Collaboratory2 and the Patient-Centered Outcomes Research Network (PCORnet).

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