"Recognizing that more is better is now an invalid assumption,1 the 2023 US Senate appropriations bill for FDA (included in S. 4661) and its report language encourage FDA to organize dose optimization clinical trials of marketed anticancer agents in an effort to reduce waste and/or toxicities of treatment without compromising efficacy."
@cyrilpedia gotta love the back-of-the-envelope calculation that they can run a 170 person clinical trial _in oncology_ for $1.7M.
@cyrilpedia and that 72-person 12 week surrogate marker (PSA) study of abi is pulling an awful lot of weight in these analyses. Yeah, if we could get drugs approved on that kind of evidence and 170 person oncology trails cost $1.7M drugs would definitely be a lot cheaper. But that’s nowhere near reality on either count.