ORGANIZATIONAL PROBLEMS PECULIAR TO MULTICENTER TRIALS - DISCUSSION

The organisation of any randomised clinical trial is fraught with diff iculties, and that of a multicentre trial particularly so. There are p roblems associated not only with the principles upon which the investi gation is based, but also with the detailed organisation and analysis. Are all the participants truly unbiased about the relative merits of the regimens studied? Is like being compared with like - are all the e nd points and the standards for measuring them clearly defined, so tha t they cannot be misunderstood? Are all eligible patients being studie d, and their results reported? Is truly informed consent being sought that will satisfy not only the patient's right to choose what happens to him, but also the law of the land? And, finally, how can the partic ipants be sure that the trial will be stopped at the right time, to en sure that no treatment is given to any patient that might be harmful? These questions may seem insoluble, but until we tackle them we shall never be certain.