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Journal of Psychiatric Practice:
doi: 10.1097/01.pra.0000442938.61575.c2
COLUMNS: Psychopharmacology

The Role of Proof of Concept (POC) Studies in Drug Development Using the EVP-6124 POC Study as an Example

PRESKORN, SHELDON H. MD

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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. (Journal of Psychiatric Practice 2014;20:59–60)

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