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1:00PM - 1:15PM EST
Introduction and Welcome
David Harpole, Duke University
David H. Harpole, Jr. is a Professor of Surgery and Pathology at the Duke University in Durham, North Carolina, where he serves as Director of the Duke Surgical Research Fellowship and leads Duke’s Lung Cancer Research Laboratory and Biorepository.
Dr. Harpole has served in the Department of Surgery and Division of Thoracic Surgery for the past 20+ years; as Vice-chairman for Faculty Affairs, Vice-chief of The Division of Surgical Sciences and Vice Chairman for Research. He was the Co-chair of the Thoracic Tumor Committee of the National Cancer Database and recently retired as a Director of the American Board of Thoracic Surgery and completed his role as a Board of Director of the International Association for the Study of Lung Cancer. He was conference president of 2021 World Conference on Lung Cancer (WCLC).
Dr. Harpole has contributed numerous articles (> 200) and abstracts to the medical literature. His work on non-small cell lung cancer, esophageal carcinoma and mesothelioma. He has directed an active translational thoracic oncology research laboratory for more 25 years that has had National Institutes of Health, Veterans Affairs and Department of Defense peer reviewed grant support and has served on NCI and VA grant review study sections for more than 15 years, including chair of the NCI R03, R21, R33 grant review study section for the last 5 years. He has led several large multi-institutional lung cancer clinical trials based on his laboratory efforts. Over the last 8 years, he was the co-chair of the NCI-CTEP Thoracic Malignancies Steering Committee that oversees all large clinical trials in lung cancer and mesothelioma in the US and Canada.Over the last two+ decades, he has trained and mentored more than 20 research fellows who hold academic positions across the US and Canada. Currently, he is the PI of three NIH-funded training grants (NCI T32, NHLBI R38 and NIAID R38).
Marco Zenati, Harvard Medical School
Dr Zenati is a Professor of Surgery at Harvard Medical School and Director of the Medical Robotics and Computer-Assisted Surgery Laboratory. Dr Zenati's research in Cardiac Surgery has been continuously funded by the NIH for 20 years. Dr Zenati is the recipient of the Alexis Carrel and of the ISHLT‘s Philp K. Caves International Awards and Chairs the Bioengineering, Technology and Surgical Sciences (BTSS) Study Section of the NIH. Dr Zenati has led multiple randomized clinical trials, including the REGROUP trial (ClinicalTrials.gov NCT01850082 published in 2019 in The New England Journal of Medicine). Dr Zenati is a pioneer of minimally invasive and robotic cardiac surgery and performed the U.S.-first beating-heart robotic coronary bypass surgery in 2000. Dr Zenati has authored more than 250 peer-reviewed publications and holds several patents. He is the Associate Editor of IEEE Transactions in Medical Robotics and Bionics. Board certified in thoracic and cardiovascular surgery, Dr. Zenati attended Catholic University School of Medicine in Rome, Italy and began his graduate medical training at the University of Verona, Italy with a research fellowship at the University of Pittsburgh. Following a 3-year cardiothoracic surgery and thoracic transplant clinical fellowship, in 1996 Dr Zenati joined the faculty of the Division of Cardiothoracic Surgery at the University of Pittsburgh as Founder and Director of the Minimally Invasive Cardiac Surgery Program and established in 1998 one of the world’s first robotic surgical programs. In 2010 Dr Zenati was recruited to Boston as Chief of Cardiac Surgery at the VA and associate surgeon in the Division of Cardiac Surgery at the Brigham and Women’s Hospital
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1:00PM - 3:30PM EST
Day One - Clinical Trials
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1:15PM - 1:35PM EST
Selecting the Clinical Question for your Trial
Eugene Blackstone, Cleveland Clinic
Eugene Blackstone, MD, is Director of Research in Cardiovascular Outcomes Registries and Research, Heart, Vascular & Thoracic Institute at Cleveland Clinic, and staff member of the Department of Thoracic and Cardiovascular Surgery, Quantitative Health Sciences and Transplant Center. He leads a multidisciplinary clinical research team of nearly 50 people, with about 180 projects ongoing at any given time. He has been Statistical Editor of the Journal of Thoracic and Cardiovascular Surgery, and has over 900 publications.
Dr. Blackstone received his medical degree at the University of Chicago in the 1960s. While there, with a select group, they developed a new scientific field: digital signal processing.
From 1969-1972, Dr. Blackstone served as a Major in the United States Army Medical Corp. He was Chief of the Cardiovascular Medicine Branch in the Aviation Medicine Research Division at Fort Rucker, AL. He was a consultant to the Office of the Surgeon General, Department of the Army, and the National Aeronautics and Space Administration on Space Lab I, Space Lab II, and Orbital Flight Tests.
In the 1970s and 1980s he and his statistical colleagues developed novel mathematical models for analysis of time-related and longitudinal clinical outcomes, as well as algorithmic approaches, quasi-experimental study design, and mathematical process-control models of the circulatory system for cardiac disease.
With Dr. Kirklin at the University of Alabama at Birmingham, he started the study of inception cohorts of North American patients with rare congenital heart disease by the Congenital Heart Surgeons Society. Since the mid-1980's, he has led a team of statisticians and computer scientists in developing novel machine learning methods, and since 1993 AI approaches to data storage and use. He has been the "consistent voice" of the Kirklin/Barratt-Boyes text "Cardiac Surgery."
Dr. Blackstone is an organist and pianist, with a 137-rank pipe organ in his home (BlackstoneOrgan.org).
- Speaker: Eugene Blackstone, Cleveland Clinic
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1:35PM - 1:55PM EST
How to Design a Randomized Trial
Scott D. Solomon, Brigham & Women's Hospital
Scott D. Solomon, MD is the Edward D. Frohlich Distinguished Chair, Professor of Medicine at Harvard Medical School and Brigham and Women’s Hospital. He received his A.B. from Williams College and his M.D. from Harvard Medical School.
Dr. Solomon’s research interests have focused on changes in ventricular structure and function following myocardial injury, modifiers of risk and influences of outcome in patients following myocardial infarction and with chronic heart failure, cardiovascular safety of non-cardiovascular therapies, factors that influence the transition from hypertension to heart failure, and heart failure with preserved ejection fraction. He has pioneered the use of cardiac imaging in cardiovascular drug and device development and use of imaging in clinical trials. He is an expert in cardiovascular safety and outcomes research and led the NIH-sponsored Celecoxib Cross-trials Safety Study which directly informed regulatory agencies about the safety of widely used non-steroidal anti-inflammatory agents.
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1:55PM - 2:15PM EST
Challenges in the Conception stage of a Randomized Trial
Robert Yeh, Beth Israel Deaconess Medical Center
Robert W. Yeh, MD MSc is the Founding Director of the Richard and Susan Smith Center for Outcomes Research at the Beth Israel Deaconess Medical Center. He holds the Katz-Silver Endowed Chair in Cardiovascular Outcomes Research and is Associate Professor of Medicine at Harvard Medical School. Dr. Yeh is also Associate Chief of Interventional Cardiology at BIDMC.
Dr. Yeh's research focuses on understanding the value of novel cardiovascular devices and therapies, studying the effects of health policy interventions on cardiovascular practice, and using novel sources of data to better predict patient and procedural risk.
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2:15PM - 2:45PM EST
Group Discussion
Scott D. Solomon, Brigham & Women's Hospital
Scott D. Solomon, MD is the Edward D. Frohlich Distinguished Chair, Professor of Medicine at Harvard Medical School and Brigham and Women’s Hospital. He received his A.B. from Williams College and his M.D. from Harvard Medical School.
Dr. Solomon’s research interests have focused on changes in ventricular structure and function following myocardial injury, modifiers of risk and influences of outcome in patients following myocardial infarction and with chronic heart failure, cardiovascular safety of non-cardiovascular therapies, factors that influence the transition from hypertension to heart failure, and heart failure with preserved ejection fraction. He has pioneered the use of cardiac imaging in cardiovascular drug and device development and use of imaging in clinical trials. He is an expert in cardiovascular safety and outcomes research and led the NIH-sponsored Celecoxib Cross-trials Safety Study which directly informed regulatory agencies about the safety of widely used non-steroidal anti-inflammatory agents.
Robert Yeh, Beth Israel Deaconess Medical Center
Robert W. Yeh, MD MSc is the Founding Director of the Richard and Susan Smith Center for Outcomes Research at the Beth Israel Deaconess Medical Center. He holds the Katz-Silver Endowed Chair in Cardiovascular Outcomes Research and is Associate Professor of Medicine at Harvard Medical School. Dr. Yeh is also Associate Chief of Interventional Cardiology at BIDMC.
Dr. Yeh's research focuses on understanding the value of novel cardiovascular devices and therapies, studying the effects of health policy interventions on cardiovascular practice, and using novel sources of data to better predict patient and procedural risk.
Eugene Blackstone, Cleveland Clinic
Eugene Blackstone, MD, is Director of Research in Cardiovascular Outcomes Registries and Research, Heart, Vascular & Thoracic Institute at Cleveland Clinic, and staff member of the Department of Thoracic and Cardiovascular Surgery, Quantitative Health Sciences and Transplant Center. He leads a multidisciplinary clinical research team of nearly 50 people, with about 180 projects ongoing at any given time. He has been Statistical Editor of the Journal of Thoracic and Cardiovascular Surgery, and has over 900 publications.
Dr. Blackstone received his medical degree at the University of Chicago in the 1960s. While there, with a select group, they developed a new scientific field: digital signal processing.
From 1969-1972, Dr. Blackstone served as a Major in the United States Army Medical Corp. He was Chief of the Cardiovascular Medicine Branch in the Aviation Medicine Research Division at Fort Rucker, AL. He was a consultant to the Office of the Surgeon General, Department of the Army, and the National Aeronautics and Space Administration on Space Lab I, Space Lab II, and Orbital Flight Tests.
In the 1970s and 1980s he and his statistical colleagues developed novel mathematical models for analysis of time-related and longitudinal clinical outcomes, as well as algorithmic approaches, quasi-experimental study design, and mathematical process-control models of the circulatory system for cardiac disease.
With Dr. Kirklin at the University of Alabama at Birmingham, he started the study of inception cohorts of North American patients with rare congenital heart disease by the Congenital Heart Surgeons Society. Since the mid-1980's, he has led a team of statisticians and computer scientists in developing novel machine learning methods, and since 1993 AI approaches to data storage and use. He has been the "consistent voice" of the Kirklin/Barratt-Boyes text "Cardiac Surgery."
Dr. Blackstone is an organist and pianist, with a 137-rank pipe organ in his home (BlackstoneOrgan.org).
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2:45PM - 3:15PM EST
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3:30PM - 6:30PM EST
Group Breakout Sessions
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6:00PM - 9:00PM EST