340.645.01 Introduction to Clinical Trials
Cancelled
- Department:
- Epidemiology
- Term:
- 2nd term
- Credits:
- 3 credits
- Academic Year:
- 2019 - 2020
- Location:
- East Baltimore
- Class Times:
-
- M W F, 1:30 - 2:20pm
- Auditors Allowed:
- Yes, with instructor consent
- Grading Restriction:
- Letter Grade or Pass/Fail
- Contact:
- Janet Holbrook
- Course Instructors:
-
- Janet Holbrook
- Evan Mayo-Wilson
- Resources:
- Prerequisite:
- Description:
-
Introduces 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 I-IV, cross-over, factorial, and large, simple designs; internal and external validity; controls, randomization, and masking; ethical issues; data analysis principles; monitoring of accumulating safety and efficacy data; and use of data from randomized trials.
- Learning Objectives:
-
Upon successfully completing this course, students will be able to:
- Present the scientific rationale for conducting clinical trials
- Assess various clinical trial designs
- Discuss randomization and the principle of analysis by assigned treatment
- Discuss 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
- Methods of Assessment:
assignments and final exam
- Instructor Consent:
Consent required for some students
- Consent Note:
Please contact instructor only if auditing, or if prerequisite not met
- For consent, contact: