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Estimation of Multiple Response Rates in Phase II Clinical Trials with Missing Observations

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Responses are often correlated in clinical trials. A patient who is not evaluable for a response may still provide some information to the response through his or her status on other responses. Under the assumption of missing at random, we propose the utilization of a self-consistent estimator. We show that the proposed estimators are more efficient than the conventional estimators by asymptotic relative efficiency and simulation study. An example from a Phase II clinical trial on children with chronic myelogenous leukemia is provided.

Keywords: Asymptotic relative efficiency; EM procedure; Maximum likelihood estimator; Mean squared error; Missing at random; Self-consistent estimator

Document Type: Research Article

Affiliations: Division of Biostatistics, Department of Epidemiology and Health Policy Research, College of Medicine, University of Florida, Gainesville, Florida, USA

Publication date: September 1, 2009

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