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polyomavirus
FA2019 p256. Does the drug SWIM (1. Safe 2. Work 3. Improve from standard 4. Market surveillance)
+3
cherrypie
key here is acknowledging that "100-200" patients is considered small/moderate, NOT "large". Large = stage 3
+1
drdoom
Briefly, it’s not size of study that defines the phase (although that’s not a bad heuristic). Phases are determined by study goal: 1 - can I give this drug to normal humans, exclusive, without killing them? (“first, do no harm.”) 2 - can I give this drug to sick humans, exclusive, and provide ANY benefit whatsoever? (“for ppl with disease, does giving the drug do better than not giving anything at all?”) 3 - is it better than the current gold standard? (“does it do better than what’s already been approved?”) and, finally, 4 - did we miss anything that phase 1,2,3 didn’t catch? (“surveil the market for adverse effects that couldn’t be captured in phase 1,2,3”)
+
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submitted by ∗lfsuarez(160)
Phase II studies test the efficacy of a drug. This second phase of testing can last from several months to two years, and involves up to several hundred affected patients.