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Practical Methods for Equivalence and Non-Inferiority Studies with Survival Response

Title: Practical Methods for Equivalence and Non-Inferiority Studies with Survival Response.
Name(s): Martinez, Elvis Englebert, author
Sinha, Debajyoti, professor directing dissertation
Levenson, Cathy W., university representative
Chicken, Eric, 1963-, committee member
Lipsitz, Stuart, committee member
McGee, Daniel, committee member
Florida State University, degree granting institution
College of Arts and Sciences, degree granting college
Department of Statistics, degree granting department
Type of Resource: text
Genre: Text
Issuance: monographic
Date Issued: 2014
Publisher: Florida State University
Place of Publication: Tallahassee, Florida
Physical Form: computer
online resource
Extent: 1 online resource (63 pages)
Language(s): English
Abstract/Description: Determining the equivalence or non-inferiority of a new drug (test drug) with a existing treatment (reference drug) is an important topic of statistical interest. Wellek (1993) pioneered the way for log-rank based equivalence and non-inferiority testing by formulating a testing procedure using proportional hazards model (PHM) of Cox (1972). In many equivalence and non-inferiority trials, two hazards functions may converge to one rather than being proportional for all time-points. In this case, the proportional odds survival model (POSM) of Bennett (1983) will be more sufficient than a Cox's PHM assumption. We show in both cases, when the wrong modeling assumption is made and Cox's PH assumption is violated, the popular procedure of Wellek (1993) has an inflated type I error. On the contrary, our proposed POS model based equivalence and non-inferiority tests maintains the practitioners desired 5% level of significance regardless of the underlying modeling assumption (e.g. Cox,1972; Wellek, 1993). Furthermore for non-inferiority trials, we introduce a method to determine the optimal sample size required when a desired power and type I error is specified and the data follows the POSM of Bennett (1983). For both of the above trials, we present simulation studies showing the finite approximation of powers and type I error rates, when the under-lying modeling assumption are correctly specified and when the assumptions are misspecified.
Identifier: FSU_migr_etd-9214 (IID)
Submitted Note: A Dissertation submitted to the Department of Statistics in partial fulfillment of the requirements for the degree of Doctor of Philosophy.
Degree Awarded: Fall Semester, 2014.
Date of Defense: November 07, 2014.
Keywords: Bennett's Proportional Odds Model, Clinical trials, Cox's Proportional Hazards Model, Equivalence Studies, Non-Inferiority Studies, Survival Analysis
Bibliography Note: Includes bibliographical references.
Advisory Committee: Debajyoti Sinha, Professor Directing Dissertation; Cathy Levenson, University Representative; Eric Chicken, Committee Member; Stuart Lipsitz, Committee Member; Dan McGee, Committee Member.
Subject(s): Statistics
Persistent Link to This Record:
Owner Institution: FSU

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Martinez, E. E. (2014). Practical Methods for Equivalence and Non-Inferiority Studies with Survival Response. Retrieved from