Some critical comments on the major HBOC clinical trials

Abstract

From the author's experience in the HBOC field of basic sciences and commercial product development some critical comments are offered on some of the negative aspects of the major human clinical trials. In particular in trials conducted in the emergency trauma setting the flaws in the execution of the trials have seriously affected the achievement of both efficacy and safety endpoints. In elective surgery trials the safety profile of the HBOC products has been the principal negative outcome. It is proposed that reducing unintentional bias is important and it be accomplished by achieving a balanced subject profile of the trial arms.