hpv genotyping trial design, page-3

Just read this whilst i wait for my cab to go into the city for dinner.

Good post by a2g re sample sizes required in a prospective study to get a meaningful sample of CIN2+ that can result in a statistically significant data set.

I'll need to look into it further but my understanding is that the RWH samples are not from a screeing poplulation but were ASCUS and hence one should see a far higher proportion of CIN2+ samples (on a % basis)

ASCUS was the route that Digene followed in getting HC2 approved by the FDA.

That being said I do not think that the current GBI study could be relevant to any FDA submission but only to a CE Mark/TGA approval.

Oh cabs here will follow this up later tonight/tomorrow

Good posts by all here and of high quality. keep it up everyone!