Clinical Trial Simulation: A Review
Clinical Trial Simulation: A Review
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DOI：
10.1038/clpt.2010.114
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发表时间：
2010-08-01
影响因子：
6.7
通讯作者：
Ploeger, B. A.
中科院分区：
文献类型：
--
作者：
Holford, N.;Ma, S. C.;Ploeger, B. A.
一般来说，建模和模拟，特别是临床试验模拟（CTS），已经被（较大的）制药公司和监管机构认为是提高药物开发过程效率的关键。这包括使用CTS来了解药物的有效性和安全性，并在开发的各个阶段优化试验设计。通过回顾2000年1月至2010年1月期间发表的论文，本文讨论了在特定药物的开发和临床使用中使用CTS的方法，应用和经验教训方面的最新进展。预计未来的CTS实验将有助于杂交的优化设计方法与计算密集型随机模拟。这将利用优化实验设计的优势，并留下评价有限数量的候选试验设计和分析程序的可能真实世界性能的任务。
Modeling and simulation in general, and specifically clinical trial simulation (CTS), have been recognized by the (larger) pharmaceutical companies and regulatory authorities as being pivotal to improving the efficiency of the drug development process. This includes the use of CTS to learn about drug effectiveness and safety and to optimize trial designs at the various stages of development. By reviewing papers published during the period January 2000-January 2010, this paper discusses recent developments with respect to methodology, applications, and lessons learned in the use of CTS in the development and clinical use of specific drugs. It is expected that future CTS experiments will be aided by the hybridization of optimal design methods with computationally intensive stochastic simulations. This will take advantage of optimizing the experimental design and leave the task of evaluating the probable real-world performance of a limited number of candidate trial designs and analysis procedures.