Overview
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.
(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.
Current Appointments & Affiliations
Professor Emeritus of Biostatistics & Bioinformatics
·
2016 - Present
Biostatistics & Bioinformatics, Division of Biostatistics,
Biostatistics & Bioinformatics
Member in the Duke Clinical Research Institute
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1974 - Present
Duke Clinical Research Institute,
Institutes and Centers
Recent Publications
Effects of Ablation Versus Drug Therapy on Quality of Life by Sex in Atrial Fibrillation: Results From the CABANA Trial.
Journal Article J Am Heart Assoc · February 7, 2023 Background Women with atrial fibrillation (AF) demonstrate more AF-related symptoms and worse quality of life (QOL). Whether increased use of ablation in women reduces sex-related QOL differences is unknown. Sex-related outcomes for ablation versus drug th ... Full text Open Access Link to item CiteInfluence of atrial fibrillation type on outcomes of ablation vs. drug therapy: results from CABANA.
Journal Article Europace · October 13, 2022 AIMS: Influence of atrial fibrillation (AF) type on outcomes seen with catheter ablation vs. drug therapy is incompletely understood. This study assesses the impact of AF type on treatment outcomes in the Catheter Ablation vs. Antiarrhythmic Drug Therapy f ... Full text Open Access Link to item CiteCost-Effectiveness of Catheter Ablation Versus Antiarrhythmic Drug Therapy in Atrial Fibrillation: The CABANA Randomized Clinical Trial.
Journal Article Circulation · August 16, 2022 BACKGROUND: In the CABANA trial (Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation), catheter ablation did not significantly reduce the primary end point of death, disabling stroke, serious bleeding, or cardiac arrest compared with d ... Full text Link to item CiteRecent Grants
The ISCHEMIA Trial - SDCC
Clinical TrialCo Investigator · Awarded by National Institutes of Health · 2011 - 2019STICHES
Clinical TrialStatistical Investigator · Awarded by National Institutes of Health · 2011 - 2019CABANA-AF Trial
Clinical TrialPrincipal Investigator · Awarded by National Institutes of Health · 2009 - 2017View All Grants
Education, Training & Certifications
University of North Carolina, Chapel Hill ·
1975
Ph.D.