Safety of coronary CT angiography and functional testing for stable chest pain in the PROMISE trial: A randomized comparison of test complications, incidental findings, and radiation dose.

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.

Dr. Mark is a clinical cardiologist with the rank of Professor of Medicine (with tenure) as well as Vice Chief for Academic Affairs in the Division of Cardiology, Department of Medicine at Duke University Medical Center. He is also the Director of Outcomes Research at the Duke Clinical Research Institute. He has been on the full-time faculty at Duke since 1985. Prior to that he completed his cardiology fellowship at Duke, his residency and internship at the University of Virginia Hospital, and received his medical degree from Tufts University and his Master’s degree from Harvard. In 1998, he was given the honor of being elected to the American Society for Clinical Investigators and in 2002 he was honored by election to the Association of American Physicians. These organizations are the two most prestigious honor societies in academic medicine. In 2009, Dr. Mark was awarded the American College of Cardiology Distinguished Scientist Award.

Dr. Mark's major research interests include medical economics and quality of life outcomes, outcomes research, and quality of medical care. Currently, Dr. Mark is directing a number of outcomes analyses for ongoing clinical trials including PROMISE (anatomic versus functional testing for coronary artery disease, NIH), CABANA (catheter ablation versus antiarrhythmic drug therapy for atrial fibrillation, NIH), ISCHEMIA (percutaneous coronary intervention versus optimal medical therapy for moderate-severe ischemia), and STICH (CABG +/- ventricular reconstruction versus medical therapy for ischemic heart disease, NIH). He was the principal author of the AHCPR Unstable Angina Guidelines and is a co-author of both the American College of Cardiology Guideline on Exercise Testing and their Coronary Stent Consensus Guideline. He is also the Editor of the American Heart Journal. Dr. Mark has published over 270 peer-reviewed articles, two books, and 80 book chapters. He lectures widely in the US, as well as in Canada, South America, and Europe.

Keywords: cost-effectiveness analysis, disease management, quality of life assessment, resource use.

My research interest includes design and analysis of cardiovascular clinical trials, medical devices, survival analysis, group-sequential analysis, time-to-recurrent or multiple events, continuous-time Markov models, stochastic process, linear model, dose-response modeling, design of experiments and adaptive designs.