刚发表在顶级医学杂志J A M A
Ivonescimab Manuscript for Harmoni-a Clinical Trial Results Published in Jama—-Ivonescimab Plus Chemotherapy in Non–Small Cell Lung Cancer With EGFR Variant. it is original investigation, just published in JAMA.
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Trying to not lose : The FDA's preference for multi-regional trials means SMMT may need to conduct additional trials. This could delay approval and increase costs, creating uncertainty in the short to medium term.
Jaguar8 Trying to not lose : FDA does not require MRCTs and it is cognizant of the difficulty carrying out MRCTs due to global differences in regulatory authorities. A lot of FDA approvals were not MRCTs
Trying to not lose Jaguar8 : While it's true that the FDA does not universally require MRCTs for all drug approvals, the agency has increasingly encouraged their use, especially for drugs intended to be marketed globally. The FDA’s guidance on MRCTs, particularly the ICH E17 guideline, supports the use of MRCTs to improve the generalizability of trial results across different populations and regions.
Trying to not lose Jaguar8 : And, recent trends and statements from the FDA, including those from key figures like Richard Pazdur, the director of the FDA’s oncology division, indicate a clear preference for multi-regional trials. Pazdur's recent remarks underscore the agency's inclination towards data from MRCTs to ensure broader applicability and relevance of clinical trial findings.
Jaguar8 Trying to not lose : “Clear preference “ is not the same as “required”. Specifically, this was a director’s remark, not a clear cut policy of FDA.
Jaguar8 Trying to not lose : “Encouraged”, but not required. Hence, not a pre-requisite for approval
Trying to not lose Jaguar8 : Duh… You can interpret it the way you like, but FDA does what they are supposed to do.
I would take any reliable source such as FDA over an unknown commenter on a broker platform :-)
Jaguar8 Trying to not lose : Haha show me the FDA policy which states it REQUIRES MRCTs for approval. I dare you show it
Trying to not lose Jaguar8 : And , check the latest news posted under MooMoo, which was published by Seeking Alpha like few hours ago
That’s FDA stand as of that latest reliable source
Jaguar8 Trying to not lose : I have conducted a quasi- experimental intervention study so I know what I’m talking about.LOL
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