DESIGN AND CONDUCT OF CLINICAL TRIALS Syllabus
Course Learning Objectives
Upon successfully completing this course, students will be able to:
- Understand the scientific rationale for conducting randomized trials
- Become familar with with various trial designs
- Understand randomization and of the principle of analysis by assigned treatment
- Be familiar with ethical issues in clinical trials and with related U.S. regulations and guidelines for the conduct of trials
- Illustrate topics with examples of clinical trials
Course DescriptionIntroduces clinical trial design in the context of epidemiological concepts, covers various topics in the design and conduct of clinical trials, and profiles clinical trials that illustrate these issues. Topics include the definition and history of clinical trials; trial designs, including phase III-IV, cross-over, factorial, and large, simple designs; internal and external validity; controls, randomization, and masking; ethical issues; introductions to data collection and management and analysis principles; monitoring of trials for safety and efficacy; and use of clinical trial data in healthcare decision-making.
Intended AudienceJHSPH students and Summer Institute participants wanting to become acquainted with basic clinical trial methodology, either to broaden their knowledge of public health and clinical research, or to obtain a basis for more advanced study of the design and conduct of clinical trials
Methods of AssessmentIn‐class assignments, exam, and class participationExercises – 50% (10% for each exercise)Final exam – 40%Class participation – 10%No exam retakes will be allowed. Conflicts with the exam date will be handled on a case‐by‐case basis.
340.601 (Principles of Epidemiology) or permission of instructor
Required Text(s)Because of the structure of the Summer Institute, there will be limited opportunities for reading assignments. Course faculty will not expect or require specific readings unless distributed in class.
- An Insider’s Guide To Clinical Trials. Curtis L. Meinert, Oxford Univisity Press, New York. 2011.
- Fundamentals of Clinical Trials. Lawrence M. Friedman, Curt D. Furberg, and David L. DeMets, Springer‐Verlag, New York, 1998.
- A Clinical Trials Manual From The Duke Clinical Research Institute: Lessons from a Horse Named Jim(2nd Ed.). Margaret B. Liu and Kate Davis. Wiley‐Blackwell, Oxford, UK. 2010.
- Clinical Trials: A Methodological Perspective. Steven Piantadosi, John Wiley and Sons, New York, 1997.
- Clinical Trials Dictionary: Terminology and Usage Recommendations. Curtis L. Meinert, Johns Hopkins Center for Clinical Trials, Baltimore, 1996.
Please see the course Session for a full list of dates and items for this course.
Academic Ethics Code
The code, discussed in the Policy and Procedure Memorandum for Students, March 31, 2002, will be adhered to in this class:
Students enrolled in the Bloomberg School of Public Health of The Johns Hopkins University assume an obligation to conduct themselves in a manner appropriate to the University's mission as an institution of higher education. A student is obligated to refrain from acts which he or she knows, or under the circumstances has reason to know, impair the academic integrity of the University. Violations of academic integrity include, but are not limited to: cheating; plagiarism; knowingly furnishing false information to any agent of the University for inclusion in the academic record; violation of the rights and welfare of animal or human subjects in research; and misconduct as a member of either School or University committees or recognized groups or organizations.
Disability Support ServicesIf you are a student with a documented disability who requires an academic accommodation, please contact Betty H. Addison in the Office of Student Life Services: firstname.lastname@example.org, 410-955-3034, or 2017 E. Monument Street.