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• W2337547317 abstract "Editor—We disagree with Mullner’s editorial1 as it took a very narrow perspective on a case in which attention should have been paid to the relations between general methodological principles of cancer trials and the social context in which the Di Bella story took place.2The editorial might give the (wrong) impression that the Di Bella trial3 was inadequate and could not show the lack of antitumour activity of Di Bella’s multitherapy. In 1982 an editorial in the New England Journal of Medicine accompanied the publication of a phase II study of the US National Cancer Institute on another anticancer “miracle” treatment named laetrile. This said that the study “closed the book on laetrile.”4 Interestingly, that study adopted the same non-randomised design (and the same negative results) as the Italian study.Have general methodological principles of clinical research in oncology changed so dramatically since then? We do not think so and suspect that the editorial indicates limited familiarity with phase II trials in oncology. Too much familiarity with a given research field may lead to blindness concerning its limitations,5 and the view is perfectly legitimate that current standards of phase II oncology trials should be abandoned. But why was not this the main theme of Mullner’s editorial? Why did all criticism exclusively target the Di Bella trial? To illustrate possible approaches to similar cases in the future a more general discussion of pros and cons of randomised versus non-randomised studies in similar cases (in terms of risk of bias, costs, time needed to get an answer, likelihood that such an answer will be accepted, acceptability, or randomisation in situations characterised by high social and political pressure, etc.) would have been useful. Is strict adherence to the dogma of randomisation always the best solution in phase II trials, when what matters is to determine whether a new drug or regimen has sufficient biological activity to warrant more extensive, costly, and time consuming studies?Maybe a commentary would have served the purpose better. Are we sure that insisting that randomised controlled trials are always absolutely needed for a perfect study will not end up, in the long run, doing more harm than good to the future of evidence based health care? We hope that the BMJ will promote a discussion around these topics." @default.
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• W2337547317 date "1999-04-17" @default.
• W2337547317 modified "2023-09-23" @default.
• W2337547317 title "The Di Bella multitherapy trial" @default.
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• W2337547317 doi "https://doi.org/10.1136/bmj.318.7190.1073" @default.
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