BookTimothy M. Pawlik, Julie A. Sosa, editors.
Summary: This extensively revised second edition is a unique and portable handbook focusing on clinical trials in surgery. It includes new educational materials addressing the rapid evolution of novel research methodologies in basic science, clinical and educational research. The underlying principles of clinical trials, trial design, the development of a study cohort, statistics, data safety, data monitoring, and trial publication for device and drug trials are also discussed. Clinical Trials provides a comprehensive resource on clinical trials in surgery and describes all the stages of a clinical trial from generating a hypothesis through to trial publication and is a valuable resource for all practicing and trainee academic surgeons.
Contents:
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 AEs, establishing SOPs, CRFs)
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.