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340.613.11
Design and Conduct of Clinical Trials

Location:
Online/Virtual
Term:
Summer Inst. term
Department:
Epidemiology
Credits:
2 credits
Academic Year:
2021 - 2022
Instruction Method:
Synchronous Online
Dates:
Mon 06/14/2021 - Fri 06/18/2021
Class Times:
  • M Tu W Th F,  1:30 - 4:50pm
Auditors Allowed:
No
Grading Restriction:
Letter Grade or Pass/Fail
Course Instructors:
Contact:
Ayesha Khan
Resources:
Prerequisite:

340.601

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 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.

Learning Objectives:

Upon successfully completing this course, students will be able to:

  1. Understand the scientific rationale for conducting randomized trials
  2. Become familiar with various trial designs
  3. Understand randomization and the principle of analysis by assigned treatment
  4. Be familiar with ethical issues in clinical trials and with related U.S. regulations and guidelines for the conduct of trials
Methods of Assessment:

This course is evaluated as follows:

  • 40% Group Work
  • 60% Final Exam

Instructor Consent:

No consent required

Special Comments:

Course will taught online via Zoom, on the dates and times the course is scheduled. For further information, please see the Institute website jhsph.edu/summerepi