340.645.81
Introduction to Clinical Trials
Course Status
Cancelled
Course Status
Cancelled
Location
Internet
Term
3rd Term
Department
Epidemiology
Credit(s)
3
Academic Year
2012 - 2013
Instruction Method
TBD
Auditors Allowed
Yes, with instructor consent
Available to Undergraduate
No
Grading Restriction
Letter Grade or Pass/Fail
Course Instructor(s)
Course Instructor(s)
Lea Drye
Contact Name
Frequency Schedule
Every Year
Resources
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.
Enrollment Restriction
Restricted to FDA Fellows in approved program