Translational Cardiothoracic Surgery

Dr Adam E. M. Eltorai, MD, PhD completed his graduate studies in Biomedical Engineering and Biotechnology along with his medical degree from Brown University. His work has spanned the translational spectrum with a focus on medical technology innovation and development. Dr. Eltorai has published numerous articles and books.Dr Jeff Bakal PhD, P.Stat. is the Program Director for Provincial Research Data Services at Alberta Health Services which operates the Alberta Strategy for Patient Oriented Research (SPOR) data platform and Health Service Statistical & Analytics Methods teams. He has over 10 years of experience working with Health Services data and Randomized Clinical Trials. He completed his PhD jointly with the Department of Mathematics and Statistics and the School of Physical Health and Education at Queen's University. He has worked on the methodology and analysis of several international studies in business strategy, ophthalmology, cardiology, geriatric medicine and the analysis of kinematic data resulting in several peer reviewed articles and conference presentations. His current interests are in developing statistical methodology for time-to-event data and the development of classification tools to assist in patient decision making processes. Thomas Ng is the Eastridge-Cole Professor of Thoracic Surgery and Chief of the Division of Thoracic Surgery at the University Tennessee. He received has extensive expertise in minimally invasive and robotic thoracic surgery and is a strong clinical researcher with over 80 peer-reviewed publications. He is highly committed to medical education and is a 4-time recipient of the Brown Medical School Department of Surgery-Outstanding Teaching Faculty Award and is also a 4-time winner of the Deans Excellence in Teaching Award. Dr Sellke is the Karl Karlson and Gloria Karlson Professor and Chief of Cardiothoracic Surgery at Brown Medical School and the Lifespan Hospitals. Dr Sellke is a native of Indiana and graduated from Wabash College and Indiana University School of Medicine. He is a noted clinical cardiothoracic surgeon, researcher, and author. Dr Sellke was the Chief of Cardiothoracic Surgery at Beth Israel Deaconess Medical Center and the Johnson and Johnson Professor of Surgery at Harvard Medical School prior to moving to Brown. His research interests include the regulation of the microcirculation in health and disease, ischemic injury and inflammation during cardiac surgery, collateral vascular formation and the use of growth factors and cell therapy to increase blood flow to ischemic tissue. His clinical research interests include optimizing outcomes after cardiac surgery, the reduction of bleeding and transfusion, and neurocognitive dysfunction and atrial fibrillation after surgery. Dr Sellke has been continuously funded by the National Institutes of Health for 28 years. He serves as Associate Editor for the Journal of Thoracic and Cardiovascular Surgery, Circulation Heart Failure and the Circulation Journal. He is on the editorial board of Circulation, Surgery, the Canadian Journal of Cardiology, and the Journal of Cardiac Surgery. He is the Editor of the 7th, 8th, 9th and 10th editions of Sabiston and Spencers' Surgery of the Chest, the 1st and 2nd editions of the Atlas of Cardiac Surgical Techniques, and he is completing work on a textbook on Acute Aortic Dissection and Acute Aortic Syndromes with international contributors. Dr. Sellke is the author of more than 525 peer-reviewed journal articles, as well as numerous book chapters and abstracts. He is the Past Chairman of the Executive Committee of the Council on Cardiovascular Surgery and Anesthesia of the American Heart Association and the Past Chairman of the Advisory Council on Cardiothoracic Surgery of the American College of Surgeons. Sellke has served on the Board of Governors of the American College of Surgeons and is was Chairman of its Humanitarian and Volunteerism Awards Committee, past-Chairman of the American Heart Association Committee on Scientific Sessions Program. He is the current Chairman of the Data Safety Monitoring Committee of the National Institutes of Health Cardiac Surgery Network and served on the Bioengineering, Technology and Surgical Science study section of the NIH. He is the Past-President of the Massachusetts Society of Thoracic Surgeons, past President of the Northeast Cardiothoracic Surgical Society and is a member of numerous other organizations including the American Association for Thoracic Surgery, Society of University Surgeons, and the American Surgical Association. Dr. Sellke is a fellow of the American College of Cardiology, the American College of Chest Physicians, American Heart Assocation, and the American College of Surgeons.

• PRE-CLINCIAL: DISCOVERY & DEVELOPMENT1. Defining the problem to solve2. Types of problems3. Drug discovery4. Device discovery5. Device classification6. Other product types7. Drug safety 8. Device prototyping 9. Device testingCLINICAL: FUNDAMENTALS10. Introduction to clinical research: What is it? Why is it needed?11. The question: Types of research questions and how to develop them12. Study population: Who and why them?13. Outcome measurements: What data is being collected and why?STATISTICAL PRINCIPLES14. Presenting data15. Common issues in analysis16. Basic statistical principles17. Distributions18. Hypotheses and error types19. Power20. Regression21. Continuous variable analyses: t-test, Man Whitney, Wilcoxin rank22. Categorical variable analyses: Chi-square, fisher exact, Mantel hanzel23. Analysis of variance24. Correlation25. Biases26. Basic science statistics27. Sample forms and templatesCLINICAL: STUDY TYPES28. Design principles: Hierarchy of study types29. Case series: Design, measures, classic example30. Case-control study: Design, measures, classic example31. Cohort study: Design, measures, classic example32. Cross-section study: Design, measures, classic example33. Clinical trials: Design, measures, classic example34. Meta-analysis: Design, measures, classic example35. Cost-effectiveness study: Design, measures, classic example36. Diagnostic test evaluation: Design, measures, classic example 37. Reliability study: Design, measures, classic example38. Database studies: Design, measures, classic example39. Surveys and questionnaires: Design, measures, classic example40. Qualitative methods and mixed methodsCLINICAL TRIALS41. Randomized control: Design, measures, classic example42. Nonrandomized control: Design, measures, classic example43. Historical control: Design, measures, classic example44. Cross-over: Design, measures, classic example45. Withdrawal studies: Design, measures, classic example46. Factorial design: Design, measures, classic example47. Group allocation: Design, measures, classic example48. Hybrid design: Design, measures, classic example49. Large, pragmatic: Design, measures, classic example50. Equivalence and noninferiority: Design, measures, classic example51. Adaptive: Design, measures, classic example52. Randomization: Fixed or adaptive procedures53. Blinding: Who and how?54. Multicenter considerations55. IDEAL FrameworkCLINICAL: PREPARATION56. Optimizing the question: Balancing significance and feasibility57. Meaningful outcome measurements58. Sample size59. Budgeting60. Ethics and review boards61. Regulatory considerations for new drugs and devices62. Funding approaches63. Subject recruitment64. Data management65. Quality control66. Report forms: Harm and Quality of Life67. Subject adherence68. Survival analysis69. Monitoring committee in clinical trialsREGULATORY70. FDA overview71. New drug application72. Device pathways73. Non-US regulatory74. Post-Market Drug Safety Monitoring75. Post-Market Device Safety Monitoring