Bonate P L
Quintiles, Clinical Pharmacokinetics, Kansas City, Missouri 64134, USA.
Pharm Res. 2000 Mar;17(3):252-6. doi: 10.1023/a:1007548719885.
Clinical trial simulation is the application of old technologies, e.g., Monte Carlo simulation, to a new problem, that problem being how to maximize the information content obtained during the drug development process with an intent to have the greatest chance of "success" in a clinical trial. When the information content of the drug is high, then simulation provides a method to synthesize that information into a coherent package that indicates the sponsor has good control over the pharmacology of the drug. From a purely financial point of view, what simulation offers pharmaceutical companies is the possibility of reducing the number of required studies, maximizing the chances for success in a clinical trial, and possibly shortening development time; all outcomes which will reduce drug development costs. The purpose of this paper is to introduce clinical trial simulation to the reader by discussing its potential in drug development, to briefly review the literature, and to make recommendations and caveats regarding its use.
临床试验模拟是将诸如蒙特卡洛模拟等旧技术应用于一个新问题，即如何在药物研发过程中最大化所获得的信息内容，以期在临床试验中获得最大的“成功”机会。当药物的信息含量很高时，模拟提供了一种将该信息整合为一个连贯整体的方法，表明申办方对药物的药理学有良好的控制。从纯粹的财务角度来看，模拟为制药公司提供了减少所需研究数量、最大化临床试验成功机会以及可能缩短研发时间的可能性；所有这些结果都将降低药物研发成本。本文的目的是通过讨论其在药物研发中的潜力向读者介绍临床试验模拟，简要回顾相关文献，并就其使用提出建议和注意事项。
