Success in Academic Surgery: Clinical Trials

Tim Pawlik MD is the current AAS Treasurer. He is an Associate Professor of Surgery and Oncology, the Hepatobiliary Surgery Program Director, and Director of the Johns Hopkins Medicine Liver Tumor Center. He completed his surgical training at the University of Michigan Hospital, his surgical oncology training at The University of Texas MD Anderson Cancer Center in Houston, a fellowship in medical ethics at the Harvard School of Public Health, and a masters in Theology from Harvard Divinity School in Boston. His main research interests are in clinical research in alimentary tract surgery, with a special interest in hepatic and pancreatobiliary disease. He has published over 125 peer-reviewed articles and 15 book chapters. Julie Ann Sosa, MD, MA is the current AAS Recorder. She is Associate Professor of Surgery and Medicine (Medical Oncology) in the Sections of Surgical Oncology and Endocrine Surgery at the Yale School of Medicine. She received her BA at Princeton University, her MA at the University of Oxford, and her MD at Johns Hopkins University, where she completed the Halsted residency program and a fellowship in surgical oncology. Her research interests are primarily in health services and clinical trials. She is widely published in outcomes and cost-effectiveness/decision analysis, with more than 120 peer reviewed publications. At Yale, she is the principal investigator for several clinical trials using novel drug therapies for advanced thyroid cancer and adrenocortical carcinoma. She is the recipient of grants from the Paget Foundation, the Association for Academic Surgery, the Donaghue Foundation, the American Geriatrics Foundation, and the Pepper Center and Women’s Health Research at Yale.

​1. Building your Clinical Trial Research Team.- 2. Clinical Trials: Ensuring Quality and Standardization.- 3. Statistics - Setting the Stage.- 4. Clinical Trials: Handling the Data.- 5. Data Safety Monitoring Boards.- 6. Planning for Data Monitoring and Audits.- 7. The Budget.- 8. Regulatory Considerations in Human Subjects Research.- 9. Publishing a Clinical Trial.- 10. Device Versus Drug Clinical Trials: Similarities and Important Differences.- 11. Defining the Study Cohort: Inclusion and Exclusion Criteria.- 12. History of Clinical Trials.- 13. Ethics of Clinical Trials.- 14. Trial Design: Overview of Study Designs (Phase I, II, III, IV, Factorial Design).