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Definition of a responder in clinical trials for functional gastrointestinal disorders: report on a symposium
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  1. W E Whitehead,
  2. E Corazziari,
  3. R Prizont,
  4. J R Senior,
  5. W G Thompson,
  6. S J O Veldhuyzen van Zanten
  1. William E Whitehead, PhD, Division of Digestive Diseases, CB # 7080, Burnett-Womack Building, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599-7080, USA. Email:william_whitehead{at}med.unc.edu

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On 10 and 11 September 1998, about 125 participants met at a symposium in Vienna, Austria, with the goal of determining whether a consensus could be developed on the definition of responders in clinical trials in the functional gastrointestinal disorders. Present at this meeting were representatives of the Food and Drug Administration (FDA) (Robert Prizont, MD, and John Senior, MD*), a representative of the Japanese International Motility Society (Kei Matsueda, MD, PhD), academic investigators from around the world, and representatives of several pharmaceutical companies currently engaged in the development of therapeutic compounds for the functional gastrointestinal disorders. The discussion centered primarily on the irritable bowel syndrome (IBS), the functional gastrointestinal disorder for which there is the largest development program underway. However, the discussion also addressed the measurement of outcomes in functional constipation.

This conference was sponsored by the Multinational Working Teams to Develop Diagnostic Criteria for Functional Gastrointestinal Disorders (MWT). Over a two year period, the executive committee of the MWT held a series of informal meetings with representatives of the FDA, and on one occasion, with a representative of the European Agency for the Evaluation of Medicinal Products. During these meetings, representatives of the regulatory groups indicated that there was a need for a more broad-based consensus on the best ways of defining responders in clinical trials. The MWT organized this conference …

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