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Ronald Ingle writes: >In BMJ 1998;317:1170 (31 October) Richard Peto writes that >using "the uncertainty principle" simplifies entry criteria >in randomised trials. > >I understand the ethical importance, but would like to >understand how it simplifies things? Seems to me that it >does not replace having entry criteria, and it complicates >the responsibility of the clinicians whose recruitment to >participating in trials Peto hopes to increase? What a coincidence. This is the other article that I am presenting at our journal club. As I understand it, Peto does indeed intend for this to completely replace entry criteria. Instead of the researchers restricting the medication to specific age groups, to a specific gender, etc., Peto intends for the clinicians who recruit patients to make all those judgements themselves. A simplistic example would be the study of a drug that was restricted to men or women beyond childbearing years because of the concern about teratogenic effects. Using Peto's guidelines, a clinician could still include a 30 year old woman in the study if she had a hysterectomy. Granted, the planners of the study could have written that exception in, but it is difficult to specify every possible contingency up front. The result, I suspect, is entry criteria that are far too restrictive in practice. It does make the job harder for the recruiting clinicians, but not any harder than the choices that they would have to make in the absence of a clinical trial. It's a good proposal in my opinion, but perhaps too radical to survive the scrutiny of most Institutional Review Boards. Steve Simon, [log in to unmask], Standard Disclaimer. STATS - Steve's Attempt to Teach Statistics: http://www.cmh.edu/stats %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%