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

PRESKORN, SHELDON H. MD

Journal of Psychiatric Practice: January 2014 - Volume 20 - Issue 1 - p 59–60
doi: 10.1097/01.pra.0000442938.61575.c2
COLUMNS: Psychopharmacology

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)

PRESKORN: University of Kansas School of Medicine-Wichita and Kansas University-Wichita Clinical Trials Unit

Over his career, Dr. Preskorn has worked with over 100 pharmaceutical companies in the United States and throughout the world. Over the past year, Dr. Preskorn has received grants/research support from or has served as a consultant, on the advisory board, or on the speakers bureau for the following: Abbott, Assurex Health, AstraZeneca, Eisai, Envivo, Impax Laboratories, Johnson & Johnson, Merck, National Institute of Mental Health, Naurex, Pfizer, Stanley Medical Research Institute, Sunovion, and Taisho.

Please send correspondence to: Sheldon H. Preskorn, MD, Kansas University-Wichita Clinical Trials Unit,1010 N. Kansas, Wichita KS 67214, spreskorn@kumc.edu

© 2014 by Lippincott Williams & Wilkins, Inc.