Im not familiar with his work, but from what you posted, it seems Prasad takes issue with the use of surrogate end points in trials, not fast track approvals. I tend to agree that surrogates and bio markers are a huge problem, but think they are a necessary evil. Drug development would screech to a halt if developers had to wait another 4-5 years for survival data. What we need is more Pase 4 postmarket trials with direct endpoints.
Interestingly, the paper linked shows that in some respects, fast tracked drugs have a better track reccord. This shouldnt be surprising as the best drugs are fast tracked.
>18 drugs failed to improve overall survival (in 6 of 15 accelerated approvals and in 12 of 21 traditional approvals)
Interestingly, the paper linked shows that in some respects, fast tracked drugs have a better track reccord. This shouldnt be surprising as the best drugs are fast tracked.
>18 drugs failed to improve overall survival (in 6 of 15 accelerated approvals and in 12 of 21 traditional approvals)