Kerry L. Lee

As a faculty-level biostatistician, my research activities are focused on the statistical and data coordination aspects of several large multicenter clinical trials, and on statistical issues in the design and analysis of collaborative clinical research projects associated with the Duke University Cardiovascular Disease Database. I am currently the principal investigator of the statistical and data coordinating center for two NIH-sponsored multicenter randomized clinical trials, namely (1) the Pacemaker Mode Selection Trial, a 2000 patient study of dual chamber versus single chamber pacing in patients with sinus node dysfunction, and (2) the Sudden Cardiac Death in heart Failure Trial a 2,500 patient, three-arm randomized trial of implantable defibrillator therapy or amiodarone versus conventional therapy in patients with class II or III congestive heart failure. During the past year my colleagues and I have completed a third trial sponsored by the NIH for which I was the principal investigator of the data coordinating center. This trial assessed the efficiency of electrophy siologic-guided antiarrhythmic therapy in patients at risk for sudden cardiac death. I also serve as the statistical director and principal statistician for the following major clinical trials:

(1) Symphony II, a 7,000 patient randomized trial of long-term oral platelet inhibition therapy in patients following an acute coronary syndrome, sponsored by Hoffman-LaRoche.

(2) PARAGON B, a 5,200 patient trial of platelet inhibition therapy in patients with unstable angina, also sponsored by Hoffman-LaRoche.

Methodologically, my research activities are focused on the analytic and design issues associated with clinical trials, on regression modeling strategies for risk assessment with logistic and proportional hazards regression models, and on methods for validating prognostic models and assessing probabilistic predictions.