Bookedited by Timothy M. Pawlik, Julie A. Sosa.
Contents:
Building Your Clinical Trial Research Team
Clinical Trials: Ensuring Quality and Standardization
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 a Clinical Trial
Device Versus Drug Clinical Trials: Similarities and Important Differences
Defining the Study Cohort: Inclusion and Exclusion Criteria
The History of Clinical Trials
Ethics of Clinical Trials
Trial Design: Overview of Study Designs (Phase I, II, III, IV, Factorial Design).