Pawlik Timothy M., Sosa Julie A. (eds.) Clinical Trials

2nd edition. — Springer, 2020. — 678 p. — (Success in Academic Surgery) — ISBN: 978-3-030-35488-6This 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.The History of Clinical Trials
Ethics (Informed Consent and Conflicts of Interest)
Generating a Testable Hypothesis and Underlying Principles of Clinical Trials
Trial Design:​ Overview of Study Designs
Defining the Study Cohort:​ Inclusion and Exclusion Criteria
Pragmatic Trials and Approaches to Transforming Care
Clinical Trials:​ Ensuring Quality and Standardization
Steps in Device and Drug Pathway Development:​ Clinical Trials, Similarities, and Differences
Statistics:​ Setting the Stage
Clinical Trials:​ Handling the Data
Data Safety Monitoring Boards
Planning for Data Monitoring and Audits
The Budget
Regulatory Considerations in Human Subjects Research
Publishing Your Clinical Trial
Pragmatic Clinical Trials
Cooperative Clinical Trials
International Trials:​ Surgical Research Networks
Inclusion of Patient-Reported Outcomes in Clinical Trials
Participation in Clinical Trials as a Clinical Trialist for the Community Surgeon