基于中央随机化的药物配送建模方法研究

Central Randomization-based Modeling for Drug Allocation

目的:探寻采用中央随机化方法的药物临床试验中中心药库动态药物配送的药量需求计算方法。方法:采用数学建模的方法,综合考虑多种影响因素,对各试验中心每天库存变化、药量需求进行测算,建立了药物配送模型。结果:通过实际完成的临床试验,模拟测算每天的发药量,对所建立的数学模型进行检验,模拟结果达到预期。结论:中心药库管理是中央随机化系统的重要环节。采用数学建模的方法,对各中心药物需求量进行合理测算,能提高中心药库的科学管理水平,保障临床试验顺利进行。

OBJECTIVE： To explore a randomization - based method for calculation of the required drug amount dynami- cally allocated by central drugstore of each clinical trial site. METHODS： Using the method of mathematical modeling with multiple related factors considered, everyday stock and drug demand of each trial site were calculated, and the model for drug- allocation was built. RESULTS： Calculating daily drug amount based on a real accomplished clinical trial. The valida- tion on the established mathematical model showed that the simulated results met our primary goals. CONCLUSION： Man- agement of central drugstore is an essential link of central randomization system. Reasonable calculation of drug amount allo- cated to each center with the use of mathematical modeling enhances the level of scientific management of central drugstores and ensures the smooth proceeding of clinical trials.