Well spotted Boiler. But nothing serious. Its a clerical error...

Well spotted Boiler. But nothing serious.

Its a clerical error that unfortunately is compounding on them.

The original entry was wrong. Instead of selecting “phase 2/3” the person entering it created one record for “Phase 2” and one record for Phase 3”

So it had two records for phase when you are only supposed to have one for this field. The system allows you to make this mistake because most fields are in fact multiple entries.

Someone in the brains trust decided the best way to fix it was to delete one record. Wrong – both records needed to be deleted and then a new one “Phase 2/3” added.

Easily fixed.

For the funny book. Lots of small biotechs with little – usually non-registered trials – swip swap around with phase all the time.

SUD (EMS) years ago were doing a P3 trial in Africa. Couldn’t recruit – and so without warning they announced non-significant results from what they claimed now was a P2 study. The results were still good they argued because the only reason they were non sig was because the sample size was too small.

POH ran what it called a P2 trial of an acne treatment in 2008(?) with 90 patients. Six months later they announced the stunning results from about 20 patients from now what was called a two stage phase one trial. I don't think anyone noticed because the results were good and other things were going on.

Different kettle of fish here. The only way PRR will be downgraded from 2/3 to 2 is if recruitment is so difficult that the whole thing has to go back to the drawing board – eligibility criteria changed and broadened. This would be big news and would be announced – not changed on the registration site hoping no one notices.

All imo Southoz