Description
Surgical education is a rapidly expanding area of surgical research and career interest, and as the Association for Academic Surgery (AAS) Fall Courses (www.aasurg.org) and International courses offer more and more specialty tracking there is a greater need for an accompanying textbook to supplement the material presented in the courses.
Table of Contents
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).
