When PACE-Gate Meets Sample Size Nuno Sepúlveda [Conference paper] Abstract PACE-Gate is the name by which the case surrounding the high-profile PACE clinical trial became publicly known. This case ended up in controversy due to a change in the pre-trial primary endpoint and a re-definition of the treatments' efficacy. The present paper concerns a different angle of the case: the statistical argumentation of the reported sample size calculations. The analysis of the per-trial research protocol and the post-trial statistical analysis plan revealed inconsistencies between the theoretical assumptions underpinning the sample size calculations and the prior beliefs of the trial's research team. The reported sample sizes also seemed inaccurate for not accounting for multiple pairwise comparisons contemplated in the trial's objectives. In conclusion, the statistical argumentation of the trial sample size is suboptimal. The question is whether PACE is either an exception or the norm with respect to incongruous sample size determination. Link (New Frontiers in Statistics and Data Science) [Paywall] Most pages are available to read on Google Books.
And especially notable that this is the reason, pre-registering their protocol, Horton gave for fast-tracking publication. Which is a special kind of con: technically they did pre-register it, they just didn't do what they pre-registered.
