Estimation after blinded sample size reassessment-Reference-Cited by-同舟云学术

Estimation after blinded sample size reassessment

Published:2016-10-02 Issue:6 Volume:27 Page:1830-1846
ISSN:0962-2802
Container-title:Statistical Methods in Medical Research
language:en
Short-container-title:Stat Methods Med Res

Author:

Posch Martin¹,Klinglmueller Florian¹²,König Franz¹,Miller Frank³

Affiliation:

1. Section for Medical Statistics, Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University of Vienna, Vienna, Austria

2. Department of Statistical Sciences, University of Padua, Padua, Italy

3. Department of Statistics, Stockholm University, Stockholm, Sweden Martin Posch and Florian Klinglmueller share first authorship.

Abstract

Blinded sample size reassessment is a popular means to control the power in clinical trials if no reliable information on nuisance parameters is available in the planning phase. We investigate how sample size reassessment based on blinded interim data affects the properties of point estimates and confidence intervals for parallel group superiority trials comparing the means of a normal endpoint. We evaluate the properties of two standard reassessment rules that are based on the sample size formula of the z-test, derive the worst case reassessment rule that maximizes the absolute mean bias and obtain an upper bound for the mean bias of the treatment effect estimate.

Publisher

SAGE Publications

Subject

Health Information Management,Statistics and Probability,Epidemiology

Link

http://journals.sagepub.com/doi/pdf/10.1177/0962280216670424

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