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

Pankaj J. Pasricha, Michael Camilleri, William L. Hasler, Henry P. Parkman

Research output: Contribution to journalArticle

14 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)1184-1190
Number of pages7
JournalClinical Gastroenterology and Hepatology
Volume15
Issue number8
DOIs
StatePublished - Aug 2017

Keywords

  • Clinical Trial Design
  • Endpoints
  • Gastroparesis

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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