Noninferiority test in survival analysis with cure fraction

• Grant number: 13/19696-5
• Support Opportunities: Scholarships abroad - Research
• Start date: February 03, 2014
• End date: February 02, 2015
• Field of knowledge: Physical Sciences and Mathematics - Probability and Statistics - Statistics
• Principal Investigator: Juliana Cobre
• Grantee: Juliana Cobre
• Host Investigator: Debajyoti Sinha
• Host Institution: Instituto de Ciências Matemáticas e de Computação (ICMC). Universidade de São Paulo (USP). São Carlos , SP, Brazil
• Institution abroad: Florida State University, United States

Abstract

The main objective of this project is to propose tests for non inferiority of survival functions that are not restricted to proportional hazards data, as do the log-rank tests, and that also accommodate data with cure fraction. The project aims to develop a statistical methodology to test the hypothesis of non-inferiority in a clinical trial, without relying on the proportional hazards model, to construct the hypotheses of the test, to obtain the rejection region, to derive the theoretical properties and develop sample size calculation methods. The development of a Bayesian procedure, as well as comparison with the existing tests, are also targets of this proposal. It also convenient examine the effects of improperly assuming proportional hazards model for the data, because different tests for non-inferiority in the literature make this assumption. Simulation studies and application to real data complement the objectives of this project. The proposal is justified by the shortage of research that accommodates such kind of data, the practical importance of study results, and the importance of working together with Prof. Debajyoti Sinha and to establish a contact with the Department of Statistics at Florida State University. It is expected to publish articles in relevant journal fields at international level, presenting work at scientific meetings in order to disseminate the work and the involved institutions. In the same way it is expected to establish a partnership between the two universities, with the view to initiate new projects and engage graduate students. (AU)