White Paper AGA: Gastroparesis: Clinical and Regulatory Insights for Clinical Trials
Pankaj J Pasricha, Michael Camilleri, William L Hasler, Henry P Parkman, Pankaj J Pasricha, Michael Camilleri, William L Hasler, Henry P Parkman
Abstract
Gastroparesis continues to represent a large unmet clinical need and a major opportunity for new drug development. This has led to increasing interest by federal funding agencies, regulatory bodies, and industry. This article summarizes the proceedings of the gastroparesis section of the "Drug Development Conference: Clinical Endpoints in Upper GI Disorders" organized by the American Gastroenterological Association in Washington, DC, on October 27-28, 2016. The presentation, diagnosis, and current therapeutic strategies are briefly reviewed, followed by a detailed discussion of the regulatory strategy, recommended endpoints, and future directions.
Keywords: Clinical Trial Design; Endpoints; Gastroparesis.
Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.
Source: PubMed