The Industrialization of Clinical Research
Published in: Health Affairs, v. 19, no. 2, Mar./Apr. 2000, p. 129-146
Posted on RAND.org on December 31, 1999
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.