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Clinical trial databases

This article was originally published in The Gray Sheet

Executive Summary

FDA Center for Drug Evaluation and Research issues March 29 guidance for establishing a databank for drug clinical trials as mandated by the FDA Modernization Act. The guidance recommends that trial sponsors submit data in four areas: descriptive information (title, protocol summary, study design/phase/type, condition or disease, intervention); recruitment information (study status, eligibility criteria/gender/age); location and contact information; and administrative data. A Health and Human Services report to Congress last November recommended postponement of such a database for device trials until 2001 so as to accumulate experience with the drug database first (1"The Gray Sheet" Dec. 6, p. 6)

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