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Comment & Response
September 3, 2014

Regulation and Comparative Effectiveness Research

Author Affiliations
  • 1OhioHealth Research and Innovation Institute, Columbus

Copyright 2014 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2014;312(9):963-964. doi:10.1001/jama.2014.7655

To the Editor Dr Platt and colleagues1 proposed waiver of informed consent and regulatory changes to facilitate the conduct of low-risk comparative effectiveness trials. Their point regarding changes implemented by health care systems in the absence of systematic evaluation is well taken, yet their thesis raises questions.

Risks and unintended consequences of research extend beyond the view by Platt et al1 of adverse events due to the intervention; their example concerning “a comparison study of marketed agents for routine bathing” (actually a study testing 3 screening and decolonization strategies for methicillin-resistant Staphylococcus aureus using 1 agent) is illustrative.2 If 1 strategy is superior, some patients may develop an infection (or an adverse reaction to an antibiotic) because of the research. In general, other potential risks exist, such as cost implications for patients based on treatment assignment.

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