Unconventional End Points in Cardiovascular Clinical Trials: Should We Be Moving Away From Morbidity and Mortality?
Background: Mortality and irreversible or major morbid events are the end points conventionally chosen for cardiovascular clinical trials because they are considered to reflect the effects of intervention on the natural history of disease. Other end points are now being considered and implemented because of the recognized limitations associated with using mortality and morbidity as the sole measures of therapeutic efficacy. Methods and Results: This article reflects the discussion and recommendations regarding nontraditional end points for cardiovascular trials generated from a meeting of clinical trial experts convened to discuss this issue. Less common end points that have been used in cardiovascular clinical trials include composite clinical scores integrating measures of quality of life with mortality and morbidity or using the function of vital organs as end points. Appropriate measurement and applications of such end points is controversial. Conclusions: More experience is needed in applying and analyzing results with these nontraditional end points to enable their optimal use in clinical trials in cardiology, but such approaches have the potential to redress many of the conceptual and actual deficiencies inherent in conventional measures of outcome.