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Previous research has identified methodological problems in the design and conduct of randomized trials that could, if left unaddressed, lead to biased results. In this report we discuss one such problem, inadequate control intervention, and argue that it can be by far the most important design characteristic of randomized trials in overestimating the effect of new treatments. Current guidelines for the design and reporting of randomized trials, such as the Consolidated Standards of Reporting Trials (CONSORT) statement, do not address the choice of the comparator intervention. We argue that an adequate control intervention can be selected if people designing a trial explicitly take into consideration the ethical principle of equipoise, also known as "the uncertainty principle."

Original publication

DOI

10.1080/714906103

Type

Journal article

Journal

Account Res

Publication Date

10/2003

Volume

10

Pages

301 - 315

Keywords

Analytical Approach, Biomedical and Behavioral Research, CONSORT Group, Empirical Approach, Bias (Epidemiology), Control Groups, Data Interpretation, Statistical, Drug Industry, Evaluation Studies as Topic, Guidelines as Topic, Humans, Placebos, Quality Control, Random Allocation, Randomized Controlled Trials as Topic, Research Design, Research Support as Topic, Therapies, Investigational, Uncertainty