Wonder how many of the current FDA rubber stampers will be in the board of pharma companies 5-10 yrs from now..
FDA approvals (just within last year) with no control arm: tazemetostat - 62 patients avapritinib - 43 pts enfortumab vedotin - 125 pts zanubrutinib - 86 pts entrectinib - 54 pts selinexor - 83 pts (subgroup analysis)https://twitter.com/califf001/status/1221209016526917636 …
-
-
- Još 4 druga odgovora
Novi razgovor -
-
-
Some of these are accelerated approvals and would still require a confirmatory trial to get the regular approval.
-
Lol. Good one. Good one. Hahaha
Kraj razgovora
Novi razgovor -
-
-
-
It does seem like the bar is being lowered in recent years. "Real world" seems like a part of that.
Kraj razgovora
Novi razgovor -
-
-
FDA need to raise the bar for approval, and academia, community, and CMS needs to figure out how to make trials cheaper and faster and more relevant. We should be doing 2-3x as many randomized trials and cost per or should be much less.
-
Becoming dependent on PFS as a primary endpoint was the original sin, because a lot of trial cost, contract negotiation, and coordinator effort goes into ensuring uniform scanning practices. oS is cheap and reliable to measure, and much more important to patients.
- Još 6 drugih odgovora
Novi razgovor -
-
-
I mean, snake oil will probably be approved at this rate. Many diseases (yes, even malignancies) display waxing and waning, which will be interpreted as a "partial response". And voila, approval!
Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi
-
-
-
In a sane world the person who coined the term for small crappy trials, would also not be the same person who gave srpt the greeenlight.
Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi
-
Čini se da učitavanje traje već neko vrijeme.
Twitter je možda preopterećen ili ima kratkotrajnih poteškoća u radu. Pokušajte ponovno ili potražite dodatne informacije u odjeljku Status Twittera.