Ann Intern Med. 2012 May 15;156(10):746-7.
Ethical dilemmas and malfunctions in clinical trials research.
Source
London School of Hygiene & Tropical Medicine, London WC1E 7HT, United Kingdom.
"The agonizing negative trend that is often seen when monitoring interim results of a clinical trial (4) is especially challenging when it involves mortality. The ACCORD (Action to Control Cardiovascular Risk in Diabetes) trial (5), which studied the effects of intensive versus standard glycemic control in patients with diabetes, is a controversial case. It was stopped early primarily because more deaths occurred in the intensive group (257 vs. 203 deaths; P = 0.01), but again with no convincing explanation of mechanisms by which this occurred. A subsequent meta-analysis (6) of ACCORD and other related trials revealed no overall excess mortality in the intensive strategy, adding weight to the argument that ACCORD's mortality difference may be a chance finding or at least an exaggeration of any truly harmful effect."
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