Medidata Solutions, New York, NY 10003, USA.
Stat Med. 2012 Dec 10;31(28):3537-44. doi: 10.1002/sim.5418. Epub 2012 Jun 27.
Dynamic allocation has received considerable attention since it was first proposed in the 1970s as an alternative means of allocating treatments in clinical trials which helps to secure the balance of prognostic factors across treatment groups. The purpose of this paper is to present a generalized multidimensional dynamic allocation method that simultaneously balances treatment assignments at three key levels: within the overall study, within each level of each prognostic factor, and within each stratum, that is, combination of levels of different factors Further it offers capabilities for unbalanced and adaptive designs for trials. The treatment balancing performance of the proposed method is investigated through simulations which compare multidimensional dynamic allocation with traditional stratified block randomization and the Pocock-Simon method. On the basis of these results, we conclude that this generalized multidimensional dynamic allocation method is an improvement over conventional dynamic allocation methods and is flexible enough to be applied for most trial settings including Phases I, II and III trials.
动态分配自 20 世纪 70 年代首次提出以来，一直受到广泛关注，它是一种在临床试验中分配治疗方法的替代手段，有助于在治疗组之间平衡预后因素。本文旨在提出一种广义多维动态分配方法，该方法可同时在三个关键层次上平衡治疗分配：整个研究中、每个预后因素的每个层次内以及每个层内，即不同因素水平的组合。此外，它还为试验提供了不平衡和自适应设计的能力。通过比较多维动态分配与传统分层区组随机化和 Pocock-Simon 方法的模拟，研究了所提出方法的治疗平衡性能。基于这些结果，我们得出结论，这种广义多维动态分配方法优于传统的动态分配方法，并且足够灵活，可以应用于大多数试验设置，包括 I 期、II 期和 III 期试验。
