Аннотация:It is time for the diabetes community to take action regarding the conduct of clinical trials on diabetic patients in the U.S.
The Declaration of Helsinki, an international document that describes ethical principles to be used in clinical investigations, states that “In any medical study, every patient, including those of a control group, if any, should be assured of the best proven diagnostic and therapeutic method” (1). I believe that many of the placebo-controlled trials currently being performed to assess new oral diabetic therapies do not meet this ethical standard. Comparing an experimental drug with a placebo is perfectly ethical when no proven effective therapy exists and when the risk-to-benefit ratio needs to be assessed. However, when effective therapy exists, the use of placebo control subjects does not meet the ethical …
