We have a very good result to treat people with some problem that affects a large population. So where to go from there, the PO in NIH asked us to do a phase II.

Because we are research guys not the clinical trial guys, the first submission was trashed. It was very upsetting. We did every thing according to the clinical trial PO but the reviewers did not give it a shit.

We decided to do the resubmission. I am working with an established professor biostastician to write the revision. She suggested the Survival and Quality of Life analysis.

Anyway, it is a randomized controlled trial with equally sized active and control group. No placebo since we have to validate it before using it. Therefore it cannot be blinded to the subjects.

As said, I am bad in stats and the only thing I know is those simple stats as regression, anova, t-test and CI. To design a trial based on the statistics is out of my mind.