GS21 1014 Design and Management of Clinical Trials

Buzdar, Aman. Four semester hours. Fall and Spring, annually. Grading System: Pass or Fail. Minimum prerequisite: Bachelor's degree.

This course will teach the basic research concepts and principles that underlie the design and actual day-to-day conduct of clinical trials using examples primarily from cancer trials. Topics include the nature of disease and its impact on research protocol design, appropriate statistics to use, and medical terminology frequently encountered in clinical research; methods to monitor human subjects' response to treatment including imaging, molecular diagnostics, and interactions and monitoring of clinical research laboratories; rules and regulations (including OHRP, FDA, and state), ethics, and human subjects training needed for clinical trials.  In addition to 21 hours of lecture, the student will be required to participate in two of three available on-site practicums (Regulatory and Ethical Concepts in Human Subjects Research; Clinical Trial Management; Data Management in Cancer Clinical Trials).  Each practicum requires 24 hours of participation.