Kerry Lee,

Department:
Biostatistics and Bioinformatics

Email Address:
lee00001@mc.duke.edu

Address:
Box 3850
DUMC
Durham, NC 27710

Telephone:
9196688725

Research Interests:
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.

Publications:
1995 -- 5. Lee KL, Woodlief LH, Topol EJ, Weaver WD, Betriu A, Col J, Simoons M, Aylward P, Van de Werf F, Califf RM for the GUSTO-I Investigators. Predictors of 30-day mortality in the era of reperfusion for acute myocardial infarction: results from an international trial of 41,021 patients. Circulation 1995;91:1659-1668.

1990 -- 4. Lee KL, Pryor DB, Pieper KS, Harrell FE Jr, Califf RM, Mark DB, Hlatky MA, Coleman RE, Cobb FR, Jones RH. Prognostic value of radionuclide angiography in medically treated patients with coronary artery disease: a comparison with clinical and catheterization variables. Circulation 1990;82:1705-1717.

1986 -- 3. Lee KL, Pryor DB, Harrell FE Jr, Califf RM, Behar VS, Floyd WL, Morris JJ, Waugh RA, Whalen RE, Rosati RA. Predicting outcome in coronary disease. Statistical models versus expert clinicians. Am J Med 1986;80:553-560.

1983 -- 2. Lee KL, Harrell FE Jr, Tolley HD, Rosati RA. A comparison of test statistics for assessing the effects of concomitant variables in survival analysis. Biometrics 1983;39:341-350.

1980 -- 1. Lee KL, McNeer JF, Starmer CF, Harris PJ, Rosati RA. Clinical judgment and statistics. Lessons from a simulated randomized trial in coronary artery disease. Circulation 1980;61:508-515.