People got tired of trialists playing games with statistics and patients dying or ineffective drugs making it to market. Now if you want to run a trial as evidence for approval, you need to specify an endpoint, how it will be tested, when, with what alpha (false positive) threshold, and what's the minimum effect size required for this.
If you are doing interim analysis, futility, or non-inferiority, you have to write that into the design, too.
People can jerk around with subgroup analyses in publications but the FDA won't accept that sort of horse shit for actual approval. And thank heavens for that.