No one has ever said regulators are part of a peer review process. The measure of this particular trial is not a concurrent placebo, but an artificial placebo that is only even allowed because it is a regulatory fix to a challenge regulators now recognize to the clinical trial process. The fix to this problem however has to be still executed within a set of parameters again that is consensus driven by national regulators, first releasing draft guidance, taking comments, then having seminars and discussions with leaders in the field, then apparently publishing articles to further get the ideas out and then ultimately using all of that process to put out final guidance that says how best to accomplish this task of creating a proper measure to show a successful trial. Now the peer reviewed may feel that there is enough now out there with regard to non-US regulators and US regulator commentary to believe they have a good measure. Having Roger Stupp likely creating the artificial placebo arm that approximates the standard of care that his team created, is also probably greatly reassuring. So there may have been a variety of ways to address the remaining ambiguity that the FDA’s very slow process has left. But the FDA was supposed to have been done with this guidance already.
Without a placebo, there is no measure for success or not. Not sure how a journal then agrees to the final review, except with cautions on those points, which again, still very possible, perhaps even likely now with so much being published involving the FDA, but nonetheless, if the FDA said, we expect the final guidance to be published in February, there could be reason to wait. If there will be no meaningful change, probably not. If the readers are comfortable that reading the multiple articles and guidance and seeing who likely assisted with the placebo, they are maybe even taking a more conservative approach, then they might be OK. But journals care about their rep, and they do not take unnecessary risks just to publish an article.
The placebo in this trial is the result of a socialized, regulatory process.
Regulators do not need to be part of the peer review, but the reviewers do need to know that the procedures were followed to generate a truly representative and not a biased placebo arm and that their end review makes sense so within that context. So they likely want to make sure their review holds up to any normal level of scrutiny.
AI
