A decision analytic approach to a futility analysis of a phase II pharmaceutical study.
In this paper we describe a decision analytic approach to doing a futility analysis of a phase II study on a drug under development. For this analysis we build a model that estimates the expected monetary value of the drug and the expected costs of development. These statistics are used to help decide whether to continue the study.
Pallay
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Wyeth-Ayerst Research, Clinical Biostatistics, Philadelphia, Pennsylvania 19101, USA. pallaya@war.wyeth.com
D000465:Algorithms; D001499:Bayes Theorem; D017322:Clinical Trials, Phase II as Topic / Q000191:economics* / Q000706:statistics & numerical data; D003362:Cost-Benefit Analysis / Q000191:economics / Q000706:statistics & numerical data; D003661:Decision Support Techniques; D004345:Drug Industry / Q000191:economics; D015507:Drugs, Investigational / Q000191:economics / Q000627:therapeutic use; D006801:Humans; D015233:Models, Statistical; D020521:Stroke / Q000188:drug therapy
D015507:Drugs, Investigational