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Course Catalog

140.885.11 NON-INFERIORITY AND EQUIVALENCE CLINICAL TRIALS

Department:
Biostatistics
Term:
Summer Inst. term
Credits:
2 credits
Academic Year:
2012 - 2013
Location:
East Baltimore
Dates:
Mon 06/25/2012 - Fri 06/29/2012
Class Times:
  • M Tu W Th F,  1:30 - 5:00pm
Auditors Allowed:
No
Grading Restriction:
Pass/Fail
Contact:
Simon Day
Course Instructors:
Frequency Schedule:
One Year Only

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Prerequisite:

Good understanding of clinical trials. Possible background course could be 140.633 (Biostatistics in Medical Product Regulation).

Description:

Presents the important differences between superiority trials and those intended to show either equivalent effect, or to show that one therapy is no worse than another (but might be better). Explores the problems of setting equivalence margins, preservation of some proportion of active control effect, and emphasizes the use of confidence intervals to interpret the results of studies. Discusses special issues of quality of the trial conduct, assay sensitivity, historical evidence of treatment effects and assumptions of constancy of treatment effects over time, including concerns over “bio-creep”. Compares sample size requirements between superiority trials, equivalence trials and non-inferiority trials. Discusses the use of different analysis populations (ITT and per-protocol) and issues of changing conclusions between non-inferiority and superiority. Discusses the regulatory aspects of trial design and interpretation, and reviews existing regulatory guidance.

Learning Objectives:

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

  1. Define “superiority”, “equivalence” and “non-inferiority” clinical trials
  2. Assess the adequacy of published examples of equivalence and non-inferiority trials
  3. Design equivalence and non-inferiority trials, knowing what special features are required
  4. Present results from trials so that equivalence or non-inferiority can be adequately interpreted
Methods of Assessment:

Final Exam

Instructor Consent:

No consent required