Applying Novel methods to the assessment of clinical outcomes in cardiovascular clinical trials.
*Jeffrey Bakal, University of Alberta  Paul Armstrong, University of Alberta  Cynthia Westerhout, University of Alberta 


Contemporary clinical trials often rely on a composite endpoint which is based on the time to first event. In many cases the first event is not the worst event, and in fact as the rate of more severe events has declined there has been a continued inclusion of less severe events. One means of adjusting for this diversity in severity is to adjust the outcomes using severity weights determined a priori. The use of a weighted endpoint also allows for the incorporation of multiple endpoints per patient. Although weighting the outcomes lowers the effective number of events, it offers additional information that reduces the variance of the estimate. Additionally, by using a weight, the totality of events is used in the analysis allowing for a more useful interpretation. This clinical and statistical advantage is especially evident with long-term follow-up where multiple non-fatal events are more common.