An examination of the relative impact of type I and type II error rates in phase II drug screening trial queues.
In this note, we highlight the fact that the choice of type I and type II error rates should not simply be set at traditional levels in the phase II clinical trial setting when considering the relative success rate of previous trials in a given disease setting. For diseases in which it is rare that a new compound is active, we argue that more stringent type I error rates in the phase II setting may be more important relative to relaxing the type II error rates. The paper itself is more of a 'thought' experiment on this topic such that specific clinical trial settings will require specific applications of this approach. This is due in part to the fact that the real-world setting is more complex relative to overall decision process in terms of moving from phase II to phase III trials than our basic illustrative model.
Department of Biostatistics, University at Buffalo, Buffalo, NY 14214-3000, USA. ahutson@buffalo.edu
Alan D
AD
Hutson
Gregory E
GE
Wilding
D017322:Clinical Trials, Phase II as Topic / Q000191:economics / Q000379:methods*; D003365:Costs and Cost Analysis; D003627:Data Interpretation, Statistical; D003657:Decision Making; D015195:Drug Design; D006801:Humans; D012107:Research Design