Draft Ulcer Guidance Could Lead to Unethical Trials, Experts Say

An FDA draft guidance could lead to unethical conduct in clinical trials that test drugs to reduce the recurrence of duodenal ulcers in adults with Helicobacter pylori infections, experts say. The draft doesn’t acknowledge the generally low success rates of approved multidrug regimens, David Graham of the Michael E. DeBakey Veterans Affairs Medical Center in Houston told CTA. As a result, it “potentially promotes unethical behavior by investigators,” including the failure to provide true informed consent about therapies known to have unacceptably low success rates, he said.
Clinical Trials Advisor