Healthy Skepticism Library item: 12790

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Publication type: Journal Article

Sim I.
Trial registration for public trust: making the case for medical devices.
J Gen Intern Med 2008 Jan; 23:
http://www.springerlink.com/content/t07wuu73t920gl03/

Abstract:

Recently, several pharmaceutical companies have been shown to have withheld negative clinical trial results from the public. These incidents have resulted in a concerted global effort to register all trials at inception, so that all subsequent results can be tracked regardless of whether they are positive or negative. These trial registration policies have been driven in large part by concern about the pharmaceutical sector. The medical device industry is much smaller, and different from the pharmaceutical industry in some fundamental ways. This paper examines the issues surrounding registration of device trials and argues that these differences with pharmaceutical should not exempt device trials from registration.

Keywords:
Clinical Protocols Clinical Trials as Topic/ethics Clinical Trials as Topic/legislation & jurisprudence* Conflict of Interest Device Approval/standards* Drug Industry/ethics Drug Industry/standards* Equipment and Supplies/ethics Equipment and Supplies/standards* Humans Interdisciplinary Communication Patient Selection/ethics* Policy Making Trust United States