Proof-of-Concept
Short description
In drug development, “Proof-of-Concept” (PoC) refers to the demonstration that a new therapeutic approach generally produces the expected effect in humans.
Synonyms
PoC
Detailed description
Proof-of-Concept is typically established in an early phase of clinical development. This involves investigating whether a new active ingredient or therapeutic approach achieves the desired biological or therapeutic effect in humans.
A successful Proof-of-Concept provides important evidence that the underlying therapeutic concept works. However, it does not yet constitute definitive proof of a treatment’s efficacy and safety. These must be investigated in further clinical trials involving larger groups of patients.
