Hacker News Reader

Parent Full thread

epistasis

Phase 1: basic safety, some amount of dose-finding. Small number of patients.

Phase 2: does it appear to work as intended, tested in a larger number of people

Phase 3: is it better than alternatives.

Then approval, followed by monitoring of the drug and side effects.

There's also an additional phase of getting insurance to pay for the new drug, which can be the most difficult.

https://www.cancer.org/cancer/managing-cancer/making-treatme...

View on HN

Nice summary! From my limited knowledge in case someone’s more interested. Don’t know if it’s different in oncology.

Phase 1 is pretty big on safety: sentinel dosing, then gradually increasing doses until the established max is reached or until serious side effects show up. Generally also includes PK/PD aspects: what is the half-life, how long it’s detectable in the body, does this match the modeling? How is the drug eliminated? All this is used to refine the dosing (if need be) but also provides a lot of the information needed for the safety documentation.

Reply on news.ycombinator.com