Doc's Errors Tainted Clinical Trial Data, FDA Says

Law360, New York (September 3, 2013, 5:57 PM EDT) -- A clinical investigator overseeing two drug trials compromised data because nurses made “educated guesses” about patient pain and participants used painkillers that obscured the effectiveness of medicines being studied, the U.S. Food and Drug Administration said in a warning letter Tuesday.

FDA officials, who redacted the names of the drugs and manufacturers involved, chastised Henry A. Frazer because a study coordinator recorded pain scores on behalf of a patient who at times was unwilling or unable to do so, despite study parameters that required patients to...
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