Statistical Issues in Comparative Clinical Studies of Biosimilars
*Gregory Levin, Food and Drug Administration Keywords: biosimilar, clinical study, margin, endpoint, surrogate, missing data In this talk, I will focus on the design, conduct, and analysis of the clinical study comparing the safety and effectiveness of the reference product and the proposed biosimilar. I will discuss key issues such as the choice and justification of the similarity margin, endpoint selection and the use of surrogates, prevention and treatment of missing data, and extrapolation of findings from one studied indication to all approved indications.
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Key Dates
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June 3, 2014 - September 7, 2015
Online Registration -
June 3, 2015 - August 15, 2015
Housing -
July 31 - August 17, 2015
Invited Abstract Editing -
August 10, 2015
Short Course materials due from Instructors -
August 26, 2015
Advanced Registration Deadline -
September 7, 2015
Cancellation Deadline -
September 16 - 18, 2015
Marriott Wardman Park, Washington, DC