The industrialization of clinical research.
Recent controversies over the protection of human subjects, payment of physicians for recruiting patients to clinical trials, Food and Drug Administration (FDA) removal of approved drugs from the market, and reporting of results of clinical trials have highlighted important facets of clinical research. Less visible has been the industrialization of clinical research, and especially of clinical trials, that is, its emergence as a "line of business" of substantial magnitude and rapid growth. The growth of drug-industry outsourcing of clinical trials and the concomitant rise of a contract research industry are described in this paper, which argues for greater transparency in the conduct of both publicly and privately sponsored clinical trials.
Rettig
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D002986:Clinical Trials as Topic / Q000191:economics / Q000592:standards*; D003284:Contract Services / Q000458:organization & administration; D004345:Drug Industry / Q000458:organization & administration*; D004465:Economic Competition; D004992:Ethics, Medical; D005161:Facility Regulation and Control / Q000458:organization & administration; D033161:Government Regulation; D006801:Humans; D008389:Marketing of Health Services / Q000458:organization & administration; D009316:National Institutes of Health (U.S.); D010344:Patient Advocacy; D018579:Patient Selection; D017149:Private Sector / Q000458:organization & administration; D012109:Research Support as Topic / Q000458:organization & administration*; D014481:United States; D014486:United States Food and Drug Administration