Several stakeholders in human research have reached a general consensus in support of public registration of clinical research trials. Internationally, the World Health Organization,1 the American Medical Association,2 the Ottawa group,3,4 the biotechnology industry,5 and the pharmaceutical industry6 have issued statements supporting clinical trial registration. In the United States, Section 113 of the Food and Drug Administration (FDA) Modernization Act of 1997 mandates clinical trial registration on Clinicaltrials.gov for serious or life-threatening conditions. However, the Act includes no enforcement mechanism.7
Levin LA, Palmer JG. Institutional Review Boards Should Require Clinical Trial Registration. Arch Intern Med. 2007;167(15):1576–1580. doi:10.1001/archinte.167.15.1576
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