Randomized clinical trials--am I by brother's keeper?
If reasonable effective therapy for a disease is available, is it then ethical to conduct placebo-controlled studies with other unproven, but potentially beneficial, agents? Some investigators prefer to use proven-therapy controls when evaluating new drugs; however, random tests done with a placebo provide more accurate results. Therefore, when may society expose some human beings to potential harm in order to seek future benefits for society as a whole? A study done by Peterson and Elashoff suggested that a placebo-controlled trials is "clearly unethical" because the patient-subjects are a "high risk," and that "informed consent" becomes a fiction because no patient who clearly understood the implications of these trials would consent. Subjects; preferences have not been given much weight. Chalmers and associates maintain that randomization studies, which have also neglected patients' preferences, are more ethical than testing new therapies in an unscientific manner. Chalmers and others stressed that the physician must believe that he has "no knowledge at all that one treatment will be better or worse, safer or more dangerous than another." Some feel that active participation by patients would expose them to greater-than-warranted risks. The FDA has stated that informed consent should be obtained from each subject or representative before he or she may participate in clinical investigation. We suggest that only the patient and investigator make the decision to participate in a joint undertaking, not the profession or the state. This will require an open dialogue between physicians and patients, with each group taking responsibility for themselves and for each other.
D002986:Clinical Trials as Topic; D003657:Decision Making; D030881:Disclosure; D004992:Ethics, Medical; D006801:Humans; D007258:Informed Consent; D010437:Peptic Ulcer / Q000188:drug therapy; D011897:Random Allocation; D035844:Researcher-Subject Relations; D012306:Risk