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. 2017 Aug;15(8):1184-1190.
doi: 10.1016/j.cgh.2017.04.011. Epub 2017 Apr 12.

White Paper AGA: Gastroparesis: Clinical and Regulatory Insights for Clinical Trials

Pankaj J Pasricha  1 , Michael Camilleri  2 , William L Hasler  3 , Henry P Parkman  4
Affiliations

White Paper AGA: Gastroparesis: Clinical and Regulatory Insights for Clinical Trials

Pankaj J Pasricha et al. Clin Gastroenterol Hepatol. 2017 Aug.

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.

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References

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