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Clinical Trial Simulation: A Review
Author(s) -
Holford N,
Ma S C,
Ploeger B A
Publication year - 2010
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2010.114
Subject(s) - clinical trial , drug development , computer science , clinical pharmacology , task (project management) , risk analysis (engineering) , process (computing) , medical physics , management science , clinical study design , medicine , operations research , drug , pharmacology , systems engineering , engineering , pathology , operating system
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. Clinical Pharmacology & Therapeutics (2010) 88 2, 166–182. doi: 10.1038/clpt.2010.114