The Importance of the Preservation of the Ethical Principle of Equipoise in the Design of Clinical Trials: Relative Impact of the Methodological Quality Domains on the Treatment Effect in Randomized Controlled Trials

Authors: Djulbegovic B.¹; Cantor A.¹; Clarke M.²

Source: Accountability in Research: Policies and Quality Assurance, Volume 10, Number 4, Number 4/October-December 2003 , pp. 301-315(15)

Publisher: Taylor and Francis Ltd

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Abstract:

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."

Document Type: Research article

Affiliations: 1: Department of Interdisciplinary Oncology, H. Lee Moffitt Cancer Center and Research Institute, at the University of South Florida, Tampa, Florida, USA 2: UK Cochrane Centre, NHS Research and Development Program, Oxford, UK

Publication date: 2003-10-01

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