Definition of a responder in clinical trials for functional gastrointestinal disorders: report on a symposium
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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
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