A generic minimization random allocation and blinding system on web
A generic minimization random allocation and blinding system on web
复制标题
网络上通用的最小化随机分配和致盲系统
DOI：
10.1016/j.jbi.2006.02.015
复制
发表时间：
2006-12-01
影响因子：
4.5
通讯作者：
Yan, Yongping
中科院分区：
文献类型：
--
作者：
Cai, Hongwei;Xia, Jielai;Yan, Yongping
背景最小化是一种动态随机化临床试验方法。尽管许多研究人员推荐使用最小化，但在随机试验中很少有报道，主要是因为围绕传统分析的有效性及其实施的复杂性存在争议。然而，最近的研究证实了最小化的统计和临床有效性。结合盲化功能的最小化随机分配系统可促进该方法在一般临床试验中的实施，尚未见报道。系统概述。该系统是一个基于web的随机分配系统，采用Pocock和Simon最小化方法。它还支持一个试验中的多个治疗组，多个同时试验，以及无需进一步编程的盲法。该系统采用通用数据库模式设计方法、Pocock和Simon最小化法和盲化法构建。它是用Microsoft Visual Basic和Active Server Pages （ASP）编程语言编写的。所有数据集使用Microsoft SQL Server数据库进行管理。还提供了一些关键的编程代码。模拟和结果。同时模拟两项临床试验，验证系统的适用性。两项试验均获得了平衡组和盲法分配结果。讨论和结论。讨论了最小化方法的实际考虑，以及在本系统中实现的技术的优点、一般适用性和缺点。最后总结了该系统的发展前景。(c) 2006爱思唯尔公司版权所有。
Background 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.Methods. 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.Discussions and conclusions. 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. (c) 2006 Elsevier Inc. All rights reserved.