Randomized Controlled Trials - AMA Manual of Style

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Randomized Controlled Trials 

Study Design and Statistics

Margaret A. Winker

and Stephen J. Lurie

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PRINTED FROM AMA MANUAL OF STYLE ONLINE (www.amamanualofstyle.com). © American Medical Association, 2009. All Rights Reserved. Under the terms of the license agreement, an individual user may print out a PDF of a single chapter of a title in AMA Manual of Style Online for personal use (for details see Privacy Policy). date: 26 November 2015

The randomized controlled trial (RCT) generally leads to the strongest inferences about the effect of medical treatments. Randomized controlled trials assess efficacy of the treatment intervention in controlled, standardized, and highly monitored settings, and usually among highly selected samples of patients. Thus, their results might not reflect the effects of the treatment in real-world settings, or in other groups of individuals who were not enrolled in the trial. Information from RCTs may thus be supplemented by results of observational studies (see , Observational Studies) as well as other types of studies. The methods of RCTs must be described in detail

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