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GS21 1014 Design and Management of Clinical Trials

  • Course Director(s): Jennifer Litton
  • Semester: Spring and Fall
  • Frequency: Annually
  • Credit Hours: 4
  • Grading System: Pass/Fail
  • Prerequisites: Consent of Course Director; For course information, contact Jonathan Aguilar at


This course will include 21 hours of lecture.  The lectures 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, medical terminology frequently encountered in clinical research, methods to monitor human subjects’ response to treatment, monitoring of clinical research laboratories; rules and regulations (including the Office of Human Research Protections, the Federal Drug Administration, and the state), and ethical concerns related to clinical trials

Three practicums, 24 hours each, will be available to students.  Each student must complete two.  The practicums include:

 (1) Topics in Regulatory and Ethical Concepts in Human Subjects Research within the Office of Protocol Research/Institutional Review Board (IRB)     Office.

Students will work in conjunction with the Office of Protocol Research/IRB Office staff at M.D Anderson to study the operational processes utilized by this office to allow for application of informed consent process and compliance with regulatory guidelines.  Students will be given a primer in the ethical evolution and application of human subjects research.  Students will apply these principles and regulations to experiences, helping to ensure their comprehensive understanding by following the scientific and ethical review processes of a research protocol involving human subjects from conception to termination by following a protocol from scientific review to IRB review process.

 (2) Topics in Compliance and Auditing of Responsible Conduct of Research within the Office of Research Education and Regulatory Management.

 Students will receive advanced instruction in the principle areas of monitoring and auditing clinical trials to ensure compliance with Responsible Conduct of Research as defined by the US Public Health Service that specifically apply to clinical trials and human research. Students will conduct a project within this office where they will follow an investigational new drug (IND) application. 

 (3) Topics in Data Management in Cancer Clinical Trials within the Phase I Program.

Students will be taught methods of collecting and interpreting data in clinical trials, and the requirements and methods to insure data security and patient confidentiality.   Students will learn how to supervise/coordinate the actual data collection and monitoring aspects of clinical trials. Students will participate as a member of a clinical trials project team under the direction of the course director and directors/coordinators of ongoing studies at MD Anderson.