- 作者：Hongwei Cai ; Jielai Xia ; Dezhong Xu ; Donghuai Gao ; Yongping Yan
- 关键词：Random allocation ; Minimization ; Multi-treatment groups ; WWW ; Blinding
- 刊名：Journal of Biomedical Informatics
- 出版年：2006
- 期刊代码：134_15320464
- 类别：cp
- 出版时间：December 2006
- 卷：39
- 期：6
- 页码：706-719
- 文件大小：1525 K
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.