Μάθημα : Introduction to Clinical Trials

1. Description

This is a standard course that prepares biostatisticians to support clinical trial projects. The course will cover fundamental aspects of the appropriate design and conduct of medical experiments involving human subjects (clinical research and clinical trials), including ethics, study design, sample size calculation, randomization, monitoring, data collection, analysis, and reporting of results.

There will be three homework assignments, each with about four weeks allowed for completion, one midterm examination, and a final class project. The relative weight of these components in the final grade is given below.

Some (but not all) lectures will be accompanied by computer laboratory sessions.

2. Prerequisites/Audience

Knowledge of analysis of variance, regression, and survival analysis is assumed, and general familiarity with clinical trials will be helpful.

3. Textbooks

• Steven Piantadosi. Clinical Trials: A Methodologic Perspective. John Wiley & Sons, New York.

• Lawrence M. Friedman, Curt D. Furberg, David L. DeMets. Fundamentals of Clinical Trials, Third Edition. Springer.

• Stuart J. Pocock. Clinical Trials. John Wiley & Sons, New York.

• Notes and handouts provided by the instructor.