Alec B. O'Connor, MD
Potential Financial Conflicts of Interest: None disclosed.
O'Connor AB. Prevention of Exacerbations of Chronic Obstructive Pulmonary Disease with Tiotropium. Ann Intern Med. 2006;144:148. doi: 10.7326/0003-4819-144-2-200601170-00022
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Published: Ann Intern Med. 2006;144(2):148.
TO THE EDITOR:
Niewoehner and colleagues'report (1) is concerning because it does not satisfy either of the 2 basic moral considerations that govern the ethics of clinical trial design (2).
The first consideration dictates that the research must strive to answer clinically important questions by using scientifically valid methods. Inhaled ipratropium can be considered a standard of care for patients with moderate to severe COPD; as evidence, this treatment had been prescribed for most patients in the tiotropium trial and most were actively taking ipratropium at the time they enrolled in the trial. As such, the trial does not answer the questions of importance to clinicians: Is tiotropium more effective than ipratroprium? Because tiotropium is more convenient for patients than ipratropium, is tiotroprium as effective as ipratropium? How does tiotropium compare in a cost-effectiveness analysis? Although a standard-of-care control is not necessarily required for a trial to be considered ethical, it is often needed to ensure that the trial results have clinical utility (2).
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