NWORTH Bangor Clinical Trials Unit, Institute of Medical & Social Care Research, Y Wern, Holyhead Road, George Site, Bangor University, Bangor, LL57 2PZ, GwyneddUK.
Trials. 2013 Jan 17;14:19. doi: 10.1186/1745-6215-14-19.
Ideally clinical trials should use some form of randomization for allocating participants to the treatment groups under trial. As an integral part of the process of assessing the effectiveness of these treatment groups, randomization performed well can reduce, if not eliminate, some forms of bias that can be evident in non-randomized trials. Given the vast set of possible randomization methods to choose from we demonstrate a method that incorporates many of the advantages of these other methods.
A step-by-step introduction of how to use the adaptive randomization algorithm for conducting a clinical trial is given.
The implications, effects and capabilities of using the adaptive randomization algorithm are fully demonstrated and explained using simulated data and examples from actual trials.
This paper provides an introduction to a dynamic type of treatment allocation, which fulfills the CONSORT requirements of participants being randomly allocated whilst maintaining a level of control of the balances overall, within the stratification variables and within the strata simultaneously. Maintaining control of the imbalances within the groups is vital particularly if interim analyses are planned.
Current controlled trials ISRCTN17551624, ISRCTN37558856, ISRCTN97185214.
理想情况下，临床试验应该使用某种形式的随机化方法将参与者分配到试验中的治疗组。作为评估这些治疗组有效性过程的一个组成部分，如果不是消除的话，随机化可以减少在非随机试验中明显存在的某些形式的偏倚。鉴于有大量可能的随机化方法可供选择，我们展示了一种方法，该方法结合了这些其他方法的许多优点。
逐步介绍了如何使用适应性随机化算法进行临床试验。
使用模拟数据和实际试验的示例，充分展示和解释了使用适应性随机化算法的影响、效果和能力。
本文介绍了一种动态的治疗分配类型，它满足 CONSORT 要求，即参与者被随机分配，同时在整个分层变量和分层内同时保持对总体平衡的控制。控制组内的不平衡至关重要，特别是如果计划进行中期分析。
当前对照试验 ISRCTN17551624、ISRCTN37558856、ISRCTN97185214。
