4 ms·
More like: Phase I: Will this treatment immediately kill people? Phase II: Does this methodology seem like the right methodology to show some sort of result i
by Alex3917 7y ago
More like:
Phase I: Will this treatment immediately kill people?
Phase II: Does this methodology seem like the right methodology to show some sort of result in larger trials?
Phase III: Does the treatment work better than some type of placebo for at least a few weeks without causing obvious and unjustifiable harms during those few weeks.
Phase IV: Let's shift our marketing budget into R&D so that we can claim to be unprofitable to congress.
- sszz 7y agoThis is a super pessimistic and misleading description of phase 2 & 3 trials; actual efficacious drugs do come out of the FDA review process. Many phase 3 trials are against standard of care rather than placebo and many are longer than a few weeks, particularly for treatments where efficacy is hard to prove.
- ozfive 7y agoOr take a long time to prove such as against cancer.
- Alex3917 7y ago> Many phase 3 trials are against standard of care rather than placebo and many are longer than a few weeks Yeah but they (usually) don't have to be tested against the existing standard of care, or tested longer than a few weeks. So really it's misleading to claim that Phase III trials guarantee anything other than the extremely minimal standard of safety and efficacy that they actually guarantee.