title: The role of proof of concept (POC) studies in drug development using the EVP-6124 POC study as an example.
abstract: The goal of early proof of concept studies, typically involving a small number of subjects and more latitude in statistical requirements, is to provide evidence that a drug is likely to be successful in later stages of drug development. Although often not published, such studies allow drug developers to make "Go/No Go" decisions about proceeding with larger, more expensive studies.
authors.affiliation: PRESKORN: University of Kansas School of Medicine-Wichita and Kansas University-Wichita Clinical Trials Unit.
authors.forename: Sheldon H
authors.initials: SH
authors.lastname: Preskorn
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D055808:Drug Discovery / Q000592:standards*; D006801:Humans; D011812:Quinuclidines / Q000627:therapeutic use*; D013876:Thiophenes / Q000627:therapeutic use*
chemical_list: C573817:7-chloro-N-quinuclidin-3-yl-benzo(b)thiophene-2-carboxamide; D011812:Quinuclidines; D013876:Thiophenes