A cost‐related approach for evaluating drug development programs
Author(s) -
Yan Eric C.,
Chen Ling
Publication year - 2004
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.1902
Subject(s) - drug development , computer science , risk analysis (engineering) , function (biology) , drug , management science , operations research , medicine , pharmacology , mathematics , engineering , evolutionary biology , biology
Abstract Most pharmaceutical statisticians make a contribution to drug development at the study level by designing and analysing clinical studies. There is less involvement at the drug project level, especially when it comes to making a strategic decision for a drug development program. Motivated by the assessment of drug safety, this paper presents a new decision rule on whether or not to continue developing a new drug based on a cost function. The cost function takes into account both type I and type II errors in a decision making problem. It also incorporates both the cost and benefit from a drug development program. This cost–benefit approach enables company senior management to evaluate a drug program objectively and make decisions in a quantitative and rational manner. The probabilities of making correct decisions are illustrated by using a real data example. Copyright © 2004 John Wiley & Sons, Ltd.