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140.885.11 NON-INFERIORITY AND EQUIVALENCE CLINICAL TRIALS

Department: Biostatistics
Term: Summer Inst. term
Credits: 2 credits
Contact: Simon Day
Academic Year: 2012 - 2013
Course Instructors:
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 Objective(s):
Upon successfully completing this course, students will be able to:
Define “superiority”, “equivalence” and “non-inferiority” clinical trials
Assess the adequacy of published examples of equivalence and non-inferiority trials
Design equivalence and non-inferiority trials, knowing what special features are required
Present results from trials so that equivalence or non-inferiority can be adequately interpreted

Methods of Assessment: Final Exam
Location: East Baltimore
Class Times:
  • Mon 06/25/2012 - Fri 06/29/2012
  • Monday 1:30 - 5:00
  • Tuesday 1:30 - 5:00
  • Wednesday 1:30 - 5:00
  • Thursday 1:30 - 5:00
  • Friday 1:30 - 5:00
Enrollment Minimum: 10
Instructor Consent: No consent required
Prerequisite:

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

Auditors Allowed: No
Grading Restriction: Pass/Fail
Frequency Schedule: One Year Only
Next Offered: 2014-2015