Replies to post #18251 on Innovation Pharmaceuticals Inc (IPIX)

[MinnieM]

Yes, I understand this... however, we have a jump ahead due to the efficacy being checked in phase I. ;)





In Reply to 'starfire'
One of the reasons Phase II & III trial failure increase is due to the fact that the sample size increases, the sample size in phase III being the largest and usually phase III studies are sometimes longitudinal too! Increase in sample size means that the statistical inferences are more reliable.

[umiak]

Where that logic fails is when the probability of efficacy is established
early on. In those cases, size supports probability. The FDA
understands this and it is why they will agree to skip phase 11 under
those circumstances. Leo spoke about the shortening of the trial
process in an interview posted here just yesterday.

[noretreat]

True. Since many cancer drugs are essentially poison, Phase 1 is a lower hurdle in some cases than the efficacy tests that come later among larger samples. However, just one person can stop a Phase 1 trial.