ONCY Those press releases are very carefully crafted. Once the trial population reaches 12 weeks, the company will complete the analysis.....this does not say that they will complete the analysis at 12 weeks (or even on the 12 week data), it just says that they will do an analysis after that maturity date.
It is my understanding that Part 1 and Part 2 of the Ph III trial will be treated as separate trials within one. Obviously, the unblinding of the first 80 patients would compromise the rest of the statistical analysis through another 400 patients. I think the unblinding of Part 1 will lead to a survival analysis at 6m and 1y. Part 2 has started fresh at Patient 1 and will be completely blinded until enrolment is complete. There would be interval evaluations of progression free survival at landmark patient enrolment numbers (no or minimal statistical penalty). Additionally, more mature survival data would be evolving in parallel from Part 1 and could be publicly available. The Adaptive statistical package allows for the evolving clinical results of Part 1 to be used to understand/predict the performance of Part II.
How much data the company gives to us is a different story, I am afraid!! Often the provided information is limited and critical raw data is considered to be "secret". I am pretty sure that the defined survival numbers from Part 1 are partly to be used to define enrolment numbers for Part 2. This is the way I understand it, anyways.
Clarifying this would be a good topic for the question period after one of the company's conference calls.....there will be one coming up, no matter what.
Cheers, Geneman
