Timothy M. Pawlik & Julie A. Sosa 
Clinical Trials [PDF ebook] 

History of Clinical Trials.- Ethics (COI, informed consent).- Generating a Testable Hypothesis and Underlying Principles of Clinical Trials.- Trial Design: Overview of Study Designs (phase I, II, III, IV, factorial design).- Defining the Study Cohort: Inclusion and Exclusion criteria (establishing eligibility and exclusion criteria, how should one define a cohort, balance between being inclusive versus selective / efficacy versus effectiveness trials).- Building your Clinical Trial Research Team (how to assemble the team: database manager, research nurse).- Clinical Trials: Ensuring Quality and Standardization (GCP, reporting of AE’s, establishing SOPs, CRF’s).- Device versus Drug Clinical Trials: Similarities and Important Differences.- Statistics – Setting the Stage (Sample Size, Power, Randomization, Type II error, Treatment allocation/stratification).- Statistics – Handling the Data (Intention to Treat analyses, Subgroups analyses, expressing the data (relative risk), handling missing data).- Data Safety Monitoring Board: Interim Analyses, Stopping Rules.- Planning for Data Monitoring and Audit.- Clinical Trials: The Budget.- Regulatory Issues (compliance issues, IRB, FDA).- Publishing your Clinical Trial (authorship, manuscript preparation, journal selection).- Pragmatic clinical trials.- Cooperative trials.- International trials.- Inclusion of Patient Reported Outcomes.- Participation in clinical trials/as a clinical trialist for the community surgeon. 

Dr. Pawlik is the Chair of Surgery at The Ohio State University Wexner Medical Center where he holds The Urban Meyer III and Shelley Meyer Chair for Cancer Research. Dr. Pawlik has given over 450 invited talks both nationally and internationally in 30 different countries. Dr. Pawlik has published over 1, 000 articles and 90 book chapters, in addition to editing eight surgical textbooks. His research has been cited close to 40, 000 times with an H-index of 100. Dr. Pawlik serves on multiple editorial boards and is Editor-in-Chief of Journal of Gastrointestinal Surgery, Deputy Editor of JAMA Surgery, as well as an Associate Editor for Annals of Surgical Oncology. Dr. Pawlik is a past-President of the Association for Academic Surgery, as well as the current President-elect of the Americas Hepato-Pancreato-Biliary Association. Dr. Pawlik’s international contributions have been recognized through his honorary memberships in the Royal Australasian College of Surgeons, Brazilian Society of Surgical Oncology, Mexican Association for Surgery of the Alimentary Tract, as well as the Society of General Surgeons of Perú and the Peruvian International Hepato-Pancreatobiliary Association. Dr. Pawlik received his BA from Georgetown University, MD at Tufts University, and then went on for advancing training in surgical oncology at MD Anderson Cancer Center.  Dr. Pawlik also received a Masters in Theology from Harvard Divinity School a Ph D from the Johns Hopkins Bloomberg School of Public Health in Clinical Investigations. Julie Ann Sosa, MD, MA is the Leon Goldman MD Distinguished Professor of Surgery and Chair of the Department of Surgery at the University of California San Francisco (UCSF), where she is also a Professor in the Department of Medicine and affiliated faculty for the Philip R. Lee Institute for Health Policy Studies. Her clinical interest is in endocrine surgery, with a focus in thyroid cancer. She is an NIH-funded investigator and author of more than 300 peer-reviewed publications, 2 books, and 50 book chapters, largely focused on outcomes research, health care delivery, hyperparathyroidism, and thyroid cancer, with a focus on clinical trials. Dr Sosa is Treasurer of the American Thyroid Association (ATA) and serves on the Board of Directors/Executive Council of the ATA and International Thyroid Oncology Group, as well as practice guidelines committees for the ATA, NCCN, and the American Association of Endocrine Surgeons. She is the Editor-in-Chief of the World Journal of Surgery and is an editor of Greenfield’s Surgery: Scientific Principles and Practice. She has mentored more than 70 students, residents, and fellows. Dr Sosa received her AB at Princeton, MA at Oxford, and MD at Johns Hopkins, where she completed the Halsted residency and a fellowship.