Abstract
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.
| Original language | English |
|---|---|
| Pages (from-to) | 157-162 |
| Number of pages | 6 |
| Journal | Pharmaceutical Statistics |
| Volume | 11 |
| Issue number | 2 |
| DOIs | |
| State | Published - Mar 2012 |
Keywords
- clinical trial design
- cost-effectiveness
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