140.885.11
Non-Inferiority and Equivalence Clinical Trials
Location
East Baltimore
Term
Summer Institute
Department
Biostatistics
Credit(s)
2
Academic Year
2012 - 2013
Instruction Method
TBD
Start Date
Monday, June 25, 2012
End Date
Friday, June 29, 2012
M, Tu, W, Th, F, 1:30 - 5:00pm
Auditors Allowed
No
Available to Undergraduate
No
Grading Restriction
Pass/Fail
Course Instructor(s)
Mary Foulkes
Simon Day
Contact Name
Frequency Schedule
One Year Only
Resources
Prerequisite
Good understanding of clinical trials. Possible background course could be 140.633 (Biostatistics in Medical Product Regulation).
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:
- 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