Public Device Trial Database Raises Confidentiality Concerns - Industry Reps
This article was originally published in The Gray Sheet
Executive Summary
Inclusion of device clinical trial information in a mandatory, public database could stifle technological innovation in the device industry, trade association reps cautioned at a July 8 public meeting sponsored by FDA.
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Patient Advocates Take Aim At Industry Confidentiality In Public Database
A public database for device clinical trials of serious or life threatening conditions is necessary to give patients access to novel device therapies, the AIDS Project Los Angelos contends, citing the Vitrasert ganciclovir implant - developed by Chiron Vision for treatment of AIDS cytomegalovirus retinitis - as one past example.
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.