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Modelling and simulation to improve decision‐making in clinical development
Author(s) -
Burman CarlFredrik,
Hamrén Bengt,
Olsson Per
Publication year - 2005
Publication title -
pharmaceutical statistics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.421
H-Index - 38
eISSN - 1539-1612
pISSN - 1539-1604
DOI - 10.1002/pst.153
Subject(s) - computer science , clinical trial , drug development , simple (philosophy) , management science , clinical decision making , marketing buzz , operations research , machine learning , artificial intelligence , medical physics , medicine , engineering , intensive care medicine , drug , philosophy , epistemology , pathology , psychiatry , world wide web
Modelling and simulation are buzz words in clinical drug development. But is clinical trial simulation (CTS) really a revolutionary technique? There is not much more to CTS than applying standard methods of modelling, statistics and decision theory. However, doing this in a systematic way can mean a significant improvement in pharmaceutical research. This paper describes in simple examples how modelling could be used in clinical development. Four steps are identified: gathering relevant information about a drug and the disease; building a mathematical model; predicting the results of potential future trials; and optimizing clinical trials and the entire clinical programme. We discuss these steps and give a number of examples of model components, demonstrating that relatively unsophisticated models may also prove useful. We stress that modelling and simulation are decision tools and point out the benefits of integrating them with decision analysis. Copyright © 2005 John Wiley & Sons, Ltd.