Abstract
Determination of the Underlying Cause of Death in Three Multicenter International HIV Clinical Trials
Lifson A R~~et al
This article describes the processes & challenges for an Endpoint Review Committee in determining & adjudicating underlying causes of death in HIV clinical trials. 3 randomized trials involving 11,593 persons from 36 countries were studied. 453 deaths were reported through January 2008; suicide accounted for 5% of these. Half of all the deaths reviewed by the committee required follow-up adjudication. 23% of the suicides required adjudication while 77% did not. It is noted the number of suicides may have been greater than reported because it was not always easy to separate accidental from intentional drug overdoses. (57 refs.)