![]() Basic science and clinical science both seek understanding at the level of the individual subject but in a mega-trial, analysis is only meaningful at the group level. In this sense, mega-trials can be repeated but cannot be replicated. The results of mega-trials cannot readily be generalised because their conclusions are observations, not causal hypotheses, and are therefore not testable. In mega-trials, randomisation serves to achieve identical allocation groups in a situation where there is poor experimental control and a large measure of between-subject variation. Mega-trials have advantages in terms of increased statistical power, but also raise several new questions of interpretation. A recent development of the therapeutic trial has been the mega-trial: a large, simple randomised trial analysed on an 'intention to treat' basis. ![]()
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