4 ms·
In the US, my "back of the napkin" estimate tends to be 8-15 years, if it passes trials.
by thebeardisred 2y ago
In the US, my "back of the napkin" estimate tends to be 8-15 years, if it passes trials.
- kiba 2y agoIs there a way to speed up trials without compromising quality?
- Retric 2y agoNot really, the process gets shortcut when the benefits of moving fast are dramatic enough. So sure we could speed things up by killing more people undergoing medical experiments. But the current approach of validating safety in humans then efficacy in humans is inherently serial. Further a lot more stuff is going into the pipeline than actually ends up working.
- adamredwoods 2y agoPossible to use surrogate endpoints, which is used for slower evolving diseases. But then the claims need to be associated with the new endpoints. FDA can fast track certain drugs, but it really needs to show amazing efficacy.
- throwup238 2y agoOnly for orphan and ultra orphan diseases where there are so few patients that it’s not economically viable to do full clinical trials. There is also a breakthrough therapy designation where the clinical evidence is solid enough to release the drug while they finish full trials but that’s only in exceptional cases.
- andrewjl 2y agohttps://www.outsourcedpharma.com/doc/an-overview-of-the-fda-special-designations-for-pipeline-drugs-0001 https://www.outsourcedpharma.com/doc/an-overview-of-the-fda-...
- notheyarent 2y agoOnly for gene therapies unfortunately