ATLnsider,
If I recall correctly, the draft guidance was floated then commented on then closed to comments and announced as finalized before the journal article in November. It was then sent off to be printed up which happened in Feb 2023. So NWBO and JAMA Oncology were both working around the draft guidance in which is stated that trials like NWBO’s would be considered on a case by case basis.
What NWBO did was to hire a third party group to take contemporary trials, which provided better data than just historical trials, and use the best available patient matching techniques to compensate for not having all patient level data from all the comparators. With this data they did cross checking for bias and had a clean review.
Because NWBO is going through a case by case review, their data analysis may very well serve as an example of how to do a correct analysis when patient level data is not available and possibly be included in the final ECA guidance. I stated the possibility of this before and it sure looks like this example is being waited on to be considered for inclusion in the final guidance based on the delay to finalize it. This would be a great tribute to Dr. Linda Liau and others who helped put this together. Best wishes.
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