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For a trial to be ethical, at the time it is designed the ethical review committees will want to be convinced that there is collective uncertainty amongst clinicians as to which treatment is superior or more appropriate for the patients. They will also need to be persuaded that the sample size and other aspects of the study design are such that the trial is likely to provide information sufficient to reduce this uncertainty and thus influence subsequent medical practice if one treatment or the other appears superior.

A clinical trial cannot go forward until the protocol has been through the appropriate ethical review processes, the exact nature of which varies from country to country. These should always include a very thorough review of the scientific aims as well as the more ‘subject’ oriented concerns to protect those who will be recruited to the trial. In brief terms, this implies that if a trial is not scientifically sound – then it should not be judged as ethically acceptable.