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Ethical assessment of industry-sponsored clinical trials: a case analysis
Franklin G Miller1, Andrew F Shorr
1Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD 20892-1156, USA. fmiller@nih.gov
Abstract:
The rapid growth of clinical trials sponsored by the pharmaceutical industry and conducted by community physicians raises concerns about the scientific quality of this research and the adequacy of protections for research participants. In this article, we present an in-depth ethical analysis of a recent industry-sponsored placebo-controlled study for treatment of asthma. The ethical analysis uses a proposed ethical framework for evaluating clinical research focusing on seven ethical requirements: (1) scientific value, (2) scientific validity, (3) fair subject selection, (4) favorable risk/benefit ratio, (5) independent review, (6) informed consent, and (7) respect for enrolled subjects.