4 ms·
Man, they really tried to use a different denominator for every one of those percentages huh. Total granted approval, total with 5 years follow up, total conver
by vikramkr 3y ago
Man, they really tried to use a different denominator for every one of those percentages huh. Total granted approval, total with 5 years follow up, total converted to approval (which includes some with less than 5 year follow up).
Edit: oh wow even more denominators, now including "percent of the drugs that were granted full approval but only with at least 5 years of follow up data":
Quote: "Of the 29 indications converted to regular approval, we identified peer-reviewed articles with confirmatory trial quality-of-life data in 26 (90%) and a reported overall survival analysis in 25 (86%)."
Then they say "drug indication pairs" meaning there are probably a few drugs with multiple indications but then it's reported as percentage of drugs. Also, the surrogate endpoints that were dismissed as not showing clinical benefit - that may or may not hold as strongly depending on which particular indication/drug pair we're talking about and what the literature on that is. Their results might still be totally valid but might be worth like, redoing the calculations yourself in a spreadsheet or something to keep track of all the different denominators, whether some of the drug/indication pairs involve the same drug and if there was a regulatory or scientific reason for that, etc. The analysis and conclusion might be good but the summary is so confusingly written that it might just be easier to redo the calculations lol