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首页> 外文期刊>British Journal of Cancer >Practical experience of randomization in cancer trials: an international survey
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Practical experience of randomization in cancer trials: an international survey

机译：癌症试验中随机化的实践经验：一项国际调查

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The results from an international survey of 15 major cancer centres have clarified how randomization is being implemented in cancer trials. As regards the mechanics of obtaining treatment assignment for each patient a system of telephone registration to a central randomization office was widely used. We also advise formal checks for patient eligibility immediately before treatment assignment, and subsequent written confirmation of randomization to the investigators. As regards statistical methods, stratification of randomization by one or two prognostic factors (and institution in multicentre trials) is commonplace. Most centres used the standard approach of random permuted blocks within strata though some others used "dynamic" institution-balancing or "minimization" methods instead. The value of stratified allocation is chiefly for the trial's credibility in having comparable treatment groups, rather than for statistical efficiency. One should avoid overstratification and use only the really important prognostic factors. One essential is that randomization should in practice work for every patient, so undue complexity is to be avoided.
机译：对15个主要癌症中心进行的国际调查结果明确了癌症试验中如何实施随机化。关于为每个患者获得治疗分配的机制，广泛使用了向中央随机办公室的电话注册系统。我们还建议在分配治疗之前立即进行患者资格的正式检查，并随后向研究人员书面确认随机分配。关于统计方法，根据一种或两种预后因素（以及在多中心试验中的使用情况）对随机分组进行分层是很普遍的。大多数中心使用分层内随机排列块的标准方法，而另一些中心则使用“动态”机构平衡或“最小化”方法。分层分配的价值主要是为了使试验具有可比的治疗组的可信度，而不是统计效率。人们应该避免过度分层，只使用真正重要的预后因素。一个要点是，在实践中随机化应该对每个患者有效，因此应避免不必要的复杂性。

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