中文摘要：

目的介绍复方优选临床试验的随机化方案设计，并评价基于网络的中央随机系统（IWRS）对提高临床试验质量的作用。方法以一个研究实例，采用IWRS进行随机化方案设计，包括随机序列分配、随机隐藏、随机化药品发放以及随机化药品供应、随机隐藏下的电子应急信件。结果基于IWRS的随机化方案，可有效避免传统随机方式可能产生的选择性偏倚，更好地实施随机隐藏，保证随机化的准确性；同时可减少药品浪费，简化管理环节，降低研究成本。结论IWRS可使随机化实施更为便捷，是提高临床试验质量和效率的重要措施之一，尤其对于大规模复杂的临床试验更是如此。

英文摘要：

Objective To introduce a scheme of randomization for a new compound drug optimization with many components, ratios and dosages, in multi - center clinical trials, and evaluate the performance of the interactive wed -based randomization system （IWRS）. Methods An example of complex clinical trial of compound drug optimization was performed based on IWRS, and all demands of randomization were evaluated. Resuits The scheme based on IWRS could effectively avoid the selection bias probably resulting from traditional randomized methods, obtain better randomization concealment, and guarantee accurate implementation of the scheme of randomization. The IWRS also could reduce pharmaceutical waste, simplify the management links, lower the research cost, and improve the quality and efficiency of clinical trials, especially for large scale and complex clinical trials. Conclusion IWRS can meat the demand of complicated randomization, and provide many important functions including random allocation, randomization concealment, drug management, and the treatment of emergency envelope.