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(Chest. 2002;121:1337-1342.)
© 2002 American College of Chest Physicians

Ethical Assessment of Industry-Sponsored Clinical Trials*

A Case Analysis

Franklin G. Miller, PhD and Andrew F. Shorr, MD, MPH

* From the Department of Clinical Bioethics (Dr. Miller), National Institutes of Health, Bethesda, MD; and Pulmonary and Critical Care Medicine (Dr. Shorr), Walter Reed Army Medical Center, Washington, DC.

Correspondence to: Franklin G. Miller, PhD, Department of Clinical Bioethics, Clinical Center, National Institutes of Health, Bldg 10, Room 1C118, Bethesda, MD 20892-1156; e-mail:fmiller{at}nih.gov

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.

Key Words: ethics • industry-sponsored clinical trials • placebo controls




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