Randomised controlled trials are accepted as the gold standard for testing the efficacy of a medical intervention. Patients included in a trial should have an equal chance of being assigned to any treatment group, ensuring that there is no systematic difference in the composition of the groups. This is achieved by randomisation. The process may be based on computer-generated random numbers or a random number table. The person assessing the eligibility of subjects must not know which group they will be allocated to. Ethically if a study ought to be randomised then it must be. Randomisation should be mentioned in the title or abstract of the report and full details should be included in the text.
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