Ethical assessment of industry-sponsored clinical trials: a case analysis.
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.
Miller
Franklin G
FG
Department of Clinical Bioethics, National Institutes of Health, Bethesda, MD 20892-1156, USA. fmiller@nih.gov
Shorr
Andrew F
AF
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D001249:Asthma / Q000188:drug therapy*; D001507:Beclomethasone / Q000009:adverse effects / Q000627:therapeutic use*; D016265:Conflict of Interest; D018849:Controlled Clinical Trials as Topic / Q000191:economics* / Q000706:statistics & numerical data; D004311:Double-Blind Method; D004345:Drug Industry; D028744:Ethics Committees, Research; D004992:Ethics, Medical; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D007258:Informed Consent; D008297:Male; D000068656:Mometasone Furoate; D018579:Patient Selection; D011244:Pregnadienediols / Q000009:adverse effects / Q000627:therapeutic use*; D012109:Research Support as Topic; D016896:Treatment Outcome
D011244:Pregnadienediols; D000068656:Mometasone Furoate; D001507:Beclomethasone