Department of
presents
Dr. Ji Zhang
Ji.Zhang at sanofi-aventis dot com
ABSTRACT
Composite endpoints are often used in clinical trials in order to increase the overall event rates, reduce the sizes of the trials and achieve desired power. For example, in a trial to study the effect of a treatment on the prevention of venous thromboembolic events (VTE) after a major orthopedic surgery of the lower limb(s), the primary endpoint is usually a composite endpoint consisting of any Deep Vein Thrombosis (DVT) identified by systematic venography of lower limbs, symptomatic and well documented non-fatal pulmonary embolism, and death from all causes. Just as any endpoint, missing data can occur in the components of the composite endpoint, therefore a patient may not have complete data but partial data for the composite endpoint. To be consistent with the intention-to-treat principle, the patient should not be discarded from the analysis. In this research, we propose an approach for the analysis of composite endpoint with missing data in components. The main idea is to first derive the probabilities of all possible study outcomes based on the appropriate model and then to combine them to obtain the overall rate for the composite endpoint. Simulations are conducted to compare the approach with several naïve methods. A data example is used to illustrate the application of the approach.
This is joint work with Hui Quan, Daowen Zhang, and Laure Devlamynck, all working in Biostatistics and Programming at Sanofi-Aventis.
Friday, January 26, 2007
3:35 - 4:35 pm
206 Cox Hall
Refreshments will be served on the second floor of Dabney Hall (left of Room 222) at 3:00 pm.