Consent and equipoise, the crucial ethical issues in randomised clinical trials

Randomised clinical trials are widely accepted as the gold standard of clinical research. They seem to be the only means of conclusively establishing a relationship between an intervention and an observed outcome. However, randomisation by definition rules out individual choice of a treatment option. The justification of randomising is that the different options are in equipoise, and therefore no patient is at a disadvantage in the trial. There is concern whether equipoise, in a strict sense, is at all possible. This would require that there is no evidence as to the comparative efficacy of the treatments to be tested. This condition is in contrast to an honest null hypothesis. Several suggestions have been made to solve the tension of the equipoise requirement and are discussed in this paper. The second important condition for randomised clinical trials is to obtain informed consent from the patient. Valid consent requires that it is given voluntarily by a competent person who is adequately informed.