HHS Suggests Congress Delay Device Trials Registry Decision Until 2001
This article was originally published in The Gray Sheet
Executive Summary
Congress should delay action on creating a device trials registry until the year 2001, "after there is one year of experience with data from privately funded trials in the drug trials registry," Secretary of Health and Human Services Donna Shalala concludes in a report on the need for and impact of a device clinical trials databank.
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Clinical trial databases
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)
Clinical trial databases
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)
Voluntary Internet-Based Device Trial Clearinghouse Suggested By MDMA
Public access via the Internet to device trial information submitted voluntarily by manufacturers is adequate to direct potential subjects to clinical studies, industry reps maintain.