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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. |