title: A cost-related approach for evaluating drug development programs.
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.
authors.affiliation: Pfizer Inc. La Jolla Laboratories, 11085 Torreyana Road, San Diego, CA 92121, USA.
authors.forename: Eric C
authors.initials: EC
authors.lastname: Yan
authors.forename: Ling
authors.initials: L
authors.lastname: Chen
mesh_terms: D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003362:Cost-Benefit Analysis; D004358:Drug Therapy / Q000592:standards*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D015397:Program Evaluation / Q000191:economics / Q000379:methods*; D014481:United States