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Ethical issues in randomised trials in surgery

George Thomas

DOI: 10.20529/IJME.2020.099


Abstract

Clinical trials are required in surgery to evaluate existing procedures and to assess the value of new techniques. Except for observational studies which are considered useful only to propose a hypothesis, all study designs require a comparator group. The randomised controlled trial (RCT) is recognised as the most robust study design. There are specific ethical difficulties in conducting RCTs.

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