Schizophrenia trials: past, present and future

Richard Doll, a pioneer of the randomised controlled trial, recently described the situation before random allocation became widely adopted. “…new treatments were almost always introduced on the grounds in the hands of Professor A or in the hands of a consultant at one of the leading teaching hospitals, the results of a small series of patients (seldom more than 50) had been superior to those recorded by Professor B (or some other consultant) or by the same consultant previously. Under these conditions variability of outcome, chance and the unconscious (let alone the conscious) bias in the selection of patients brought about apparently important differences in the results obtained.” (Doll, 1998). In order to evaluate the effect of a specific treatment, the consequence of using this treatment in a group of people should be compared with not using it in a control group. The only difference in the two groups should be that one receives the treatment under evaluation, and the only way to achieve this is through random allocation. It is now over 50 years since the value of streptomycin in tuberculosis was demonstrated in the first randomised trial (Medical Research Council Streptomycin in Tuberculosis Trials Committee, 1948) and this methodology is now seen as the ‘gold standard ’ means by which different forms of mental health care are evaluate