3 ms·
Lack of statistical power. Phase I enrol too few subjects for efficacy. The reason they do a Phase I is to determine it would be safe to do a larger trial. Sou
by acveilleux 12y ago
Lack of statistical power. Phase I enrol too few subjects for efficacy. The reason they do a Phase I is to determine it would be safe to do a larger trial.
Source: I used to work for the company that is most likely to have done any MRI analysis for this study. We did Phase I/II/III and they are very different beasts.
- kirsebaer 12y agoA small study will lack statistical power to detect small effect sizes, but a small study could still detect a large effect.
- pcrh 12y agoThe point of statistical tests is to assess the accuracy of a prediction. These trials were not designed to predict/test the efficacy of the drug, therefore no conclusion regarding efficacy can be drawn. It is of course possible that there was a real effect, and that this is reflected in the data gathered, however to determine if that is the case another trial has to be performed.