i have posed this query a few times, and will again as there has some discussion about trail design, endpoints, and secondary. the query is around changing the priimary end point and at what piont this can be done, is seem during is more common, but wondering if FDA can accept post trial, give we had a great result with mortality rates as our secondary endpoint..... the headlines smashed up saying phase 3 trial fail. but it was not. Si has made comment many times that the FDA were mostly interested in the secondary enpoint when designing our trial ie mortality, no so much end up back in hospital- for which MSB found that those going back to hospitla still had great results for that point too. this link seems to suggest, changing a primary end point during a trial, but also seems open to changes due to changing circumstance, I believe some sort of appoval will come from the outstanding results on the secondary endpiont of people staying alive. can one image some headlines saying MSB went for approval with saving up to 60% of the people with heart failiure and the FDA, when the current rate is 5%,....., said NO, not good enough. not possilbe is it, regulartory process? must a be a way. feeling more confident. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1852589/ any thoughts from some of the great medical FDA insighters?
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