Cai Hongwei, Xia Jielai, Xu Dezhong, Gao Donghuai, Yan Yongping
Network Center, Fourth Military Medical University, No. 17 Changle West Road, Xi'an, Shaanxi 710032, China.
J Biomed Inform. 2006 Dec;39(6):706-19. doi: 10.1016/j.jbi.2006.02.015. Epub 2006 Feb 28.
Minimization is a dynamic randomization method for clinical trials. Although recommended by many researchers, the utilization of minimization has been seldom reported in randomized trials mainly because of the controversy surrounding the validity of conventional analyses and its complexity in implementation. However, both the statistical and clinical validity of minimization were demonstrated in recent studies. Minimization random allocation system integrated with blinding function that could facilitate the implementation of this method in general clinical trials has not been reported. SYSTEM OVERVIEW: The system is a web-based random allocation system using Pocock and Simon minimization method. It also supports multiple treatment arms within a trial, multiple simultaneous trials, and blinding without further programming.
This system was constructed with generic database schema design method, Pocock and Simon minimization method and blinding method. It was coded with Microsoft Visual Basic and Active Server Pages (ASP) programming languages. And all dataset were managed with a Microsoft SQL Server database. Some critical programming codes were also provided. SIMULATIONS AND RESULTS: Two clinical trials were simulated simultaneously to test the system's applicability. Not only balanced groups but also blinded allocation results were achieved in both trials.
Practical considerations for minimization method, the benefits, general applicability and drawbacks of the technique implemented in this system are discussed. Promising features of the proposed system are also summarized.
最小化法是一种用于临床试验的动态随机化方法。尽管许多研究人员推荐使用，但在随机试验中很少有关于最小化法应用的报道，主要是因为围绕传统分析有效性的争议及其实施的复杂性。然而，最近的研究证明了最小化法在统计学和临床方面的有效性。尚未有关于集成了盲法功能的最小化随机分配系统的报道，该系统能够促进此方法在一般临床试验中的实施。
该系统是一个基于网络的随机分配系统，采用波科克和西蒙最小化法。它还支持试验中的多个治疗组、多个同步试验，并且无需进一步编程即可实现盲法。
该系统采用通用数据库模式设计方法、波科克和西蒙最小化法以及盲法构建。它使用微软Visual Basic和动态服务器页面（ASP）编程语言进行编码。所有数据集均由微软SQL Server数据库管理。还提供了一些关键的编程代码。
同时模拟了两项临床试验以测试该系统的适用性。两项试验均实现了组间平衡以及盲法分配结果。
讨论了最小化法的实际考量、该系统所实施技术的优点、普遍适用性和缺点。还总结了所提议系统的有前景的特征。
