Clinical trial challenges

[charlotte17]

Does anyone know of any challenges related to clinic trial of pharmacotherapies particular in phase 2 and 3?

 

I have bio - availability, plasma half-life, compliance and side effects. Not sure which would fit where though.

[Function]

Compliance seems rather a challenge of phase 3 and 4 studies; to a lesser degree phase 2.

 

Bioavailability, plasma half-life would seem phase 2 to me, and side-effects actually phase 1 or 2: some side-effects may already be observed in a preclinical phase in laboratory animals.

 

Efficacy is typically phase 3, whereas efficiency (cost-effectiveness) applies to phase 4 studies ...

 

Of course, the degree to which you may or may not extrapolate your results is a huge problem in phase 2 and 3 studies.