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Viewpoint |

Promoting Informed Decision Making for Comparative Effectiveness Randomized Trials

Elliott M. Weiss, MD1,2; Steven Joffe, MD, MPH2,4
[+] Author Affiliations
1Division of Neonatology, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
2Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia
4Division of Oncology, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
JAMA Pediatr. 2015;169(9):803-804. doi:10.1001/jamapediatrics.2015.0906.
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This Viewpoint proposes that disclosures in comparative effectiveness randomized clinical trials should provide patients with appropriate information, including about risks, that are necessary to decide whether to join the trial, request a study treatment outside the trial, or select another available treatment.

The US Code of Federal Regulations governing human participants research requires that investigators disclose reasonably foreseeable risks of a research study to prospective participants during the informed consent process. Although this mandate appears straightforward, controversy surrounds how investigators should define and describe risks of comparative effectiveness randomized clinical trials (CE-RCTs) that compare treatments within accepted standards of care. The Office for Human Research Protections (OHRP) has published draft guidance prompted by the controversy of the Surfactant, Positive Pressure, and Pulse Oximetry (SUPPORT) trial of oxygenation targets in premature infants to address this question. The draft guidance concludes that “if a research study examining standards of care includes as a purpose evaluating identified risks associated with those standards of care, the identified risks associated with the standards of care being evaluated that are different from the risks of standards of care at least some of the subjects would be exposed to outside of the research study are generally considered…to be reasonably foreseeable risks of research.”1

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