The use of unequal randomisation in clinical trials--An update

Abstract

Objective: To update a 2005 review of the reasons researchers have given for the use of unequal randomisation in randomised controlled trials (RCTs).

Main measures: Intervention being tested; type of study; number of participants; randomisation ratio; sample size calculation and reason given for using unequal randomisation.

Methods: Review of trials using unequal randomisation.

Databases and sources: Cochrane library, Medline and CINAHL.

Results: A total of 86 trials were identified. Of these 82 trials (95%) recruited patients in favour of the experimental group. Various reasons for the use of unequal randomisation were given including: gaining treatment experience; identification of adverse events; ethical; logistic and enhancing recruitment. No trial reported explicitly used it for cost-effectiveness. Most of the papers (i.e. 47, 55%) did not state why they had used unequal randomisation and only 38 trials (44%) appeared to have taken the unequal randomisation into account in their sample size calculation.

Conclusion: Most studies did not mention the rationale for unequal allocation, and a significant proportion did not appear to account for it in the sample size calculations. Unlike the previous review economic considerations were not stated as a rationale for its use. A number of trials used it to enhance recruitment, although this has not been tested.

Keywords: Randomised controlled trials; Unequal randomisation.