I guess the big question to ask Dr T is about the positive pre IND guidance recently received from the FDA and whether this included positive guidance on this cardio protection trial with it's synthetic control arm?
Looking into this method some more, it does seem to be growing in popularity and acceptance. I found this review very informative for anyone who is interested - it includes lots of examples from oncology:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7218288/
Ann: Ethics submission to commence cardioprotection trial, page-28
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