Helicobacter Pylori Eradication Therapy Research: Ethical Issues and Description of Results
Graham, David Y
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association 2010 Dec; 8(12): 1032-6
As an infectious disease, the approach to anti-Helicobacter pylori therapy differs from other common gastrointestinal conditions because treatment success of more than 90% to 95% should be expected and the reasons for treatment failure can always be understood. Neither comparisons with another regimen nor randomization are required to identify a highly successful therapy. Treatment success should be judged first in relation to outcome (i.e. >= 95% or grade A). Inclusion of a known inferior regimen in a clinical trial is generally unethical. If the use of a known inferior drug is required by a regulatory agency, subjects must be given full and accurate information regarding expectations with each regimen; there can be no deceptions. Comparative trials should be restricted to highly successful treatments (i.e., comparisons of different doses, durations, compliance, cost, and so forth). Success should be judged as ordered categories such as
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