E-drug: NEJM this week: Clinical trials ethics (cont'd)
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If some patients are intolerant to ACE inhibitors, the investigator
has two ethical options:
a. conduct a placebo-controlled trial only in ACE inhibitor-intolerant
patients (see, eg, Granger, et al Am Heart J 2000;139(4):609-617)
OR
b. conduct an active-controlled trial, allowing cross-over from the
ACE inhibitor group separately, providing very useful clinical
information.
If 4% of ACE inhibitor-receiving patients develop cough, this is no
justification for 96% of patients in a comparison arm to receive
placebo.
Peter Lurie, MD, MPH
Deputy Director
Public Citizen's Health Research Group
1600 20th Street, NW
Washington, DC 20009
Phone: (202)588-7781
Fax: (202)588-7796
Email: plurie@citizen.org
Web address: http://www.citizen.org
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