多中心临床试验的随机化方案设计

Designment of Randomized Scheme of Multi-center Clinical Trial

目的研究多中心临床试验随机化方案设计的操作规程。方法首先设定随机化参数,以及对试验中心、试验病例和处理组的随机化规定,据此编制SAS随机化程序。程序设计遵循多个分层因素采用同一种子数,随机编码的连续性和可重复性的原则。结果与结论该方案可以规范、快捷地产生随机数字,并完成随机编码设计和排列。

Objective: To explore the operating procedure for designing the randomized scheme of multi-center clinical trial. Methods: SAS randomized program was written in accordance with the randomized parameters and stipulated randomized rules of centers, cases and blocks. The design of the SAS randomized program adopts the same seed in multi-hierarchical factors, and the principles of succession and repeatability of the randomized code. Results: This program can produce randomized numbers and complete the design and permutation of randomized codes in a standard and convenient way.