4 ms·
Why would the statisticians be anonymous? I'm aware of at least a couple cases in which an independent set of statisticians were provided the data from a clinic
by jonlucc 3y ago
Why would the statisticians be anonymous? I'm aware of at least a couple cases in which an independent set of statisticians were provided the data from a clinical trial specifically for a re-analysis. In one case, they showed some pretty concerning inconsistencies and the other confirmed no effect on the primary analysis, but suggested some sub-populations that might have shown an effect if a future study was properly powered. That follow-up clinical trial was just published showing pretty remarkable effect in the sub-population. I don't think there's reason to believe either independent analysis was anything other than independent.
There is already a mechanism for companies to submit questions to the FDA prior to clinical trial initiation. I'm not in these conversations, but I know the type of questions can be things like: would you accept this endpoint as a proxy for this indication, would you be satisfied with the effect size we expect, and are there other safety concerns you would expect us to evaluate other than those in our current plan. I assume EMA and other regulatory bodies have a similar process, but I'm not positive.
Disclaimer: I work in pharma, but pre-clinically. I am not involved in these clinical or regulatory issues.
- obblekk 3y agoSo junior scientists can be hired without them being concerned for future career prospects.