Trial registration for public trust: making the case for medical devices.
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.
Sim
Ida
I
Division of General Internal Medicine, Department of Medicine, University of California, San Francisco, 400 Parnassus Ave., Rm. A-405, San Francisco, CA 94143-0320, USA. ida.sim@ucsf.edu
D002985:Clinical Protocols; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence*; D016265:Conflict of Interest; D018795:Device Approval / Q000592:standards*; D004345:Drug Industry / Q000941:ethics / Q000592:standards*; D004864:Equipment and Supplies / Q000941:ethics / Q000592:standards*; D006801:Humans; D033183:Interdisciplinary Communication; D018579:Patient Selection / Q000941:ethics*; D011050:Policy Making; D035502:Trust; D014481:United States