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Biostatistics Advance Access originally published online on October 14, 2008
Biostatistics 2009 10(2):275-281; doi:10.1093/biostatistics/kxn034
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© The Author 2008. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oxfordjournals.org.

Exact and efficient inference procedure for meta-analysis and its application to the analysis of independent 2 x 2 tables with all available data but without artificial continuity correction

Lu Tian*

Department of Preventive Medicine, Northwestern University, Chicago, IL 60611, USA, lutian{at}northwestern.edu

Tianxi Cai

Department of Biostatistics, Harvard University, Boston, MA 02115, USA

Marc A. Pfeffer

Cardiovascular Division, Brigham & Women's Hospital, Boston, MA 02115, USA

Nikita Piankov

Analysis Group, Boston, MA 02115, USA

Pierre-Yves Cremieux

Department of Economics, University of Quebec at Montreal, Montreal, Quebec, Canada and Analysis Group, Boston, MA 02115, USA

L. J. Wei

Department of Biostatistics, Harvard University, Boston, MA 02115, USA

* To whom correspondence should be addressed.

Recently, meta-analysis has been widely utilized to combine information across comparative clinical studies for evaluating drug efficacy or safety profile. When dealing with rather rare events, a substantial proportion of studies may not have any events of interest. Conventional methods either exclude such studies or add an arbitrary positive value to each cell of the corresponding 2x2 tables in the analysis. In this article, we present a simple, effective procedure to make valid inferences about the parameter of interest with all available data without artificial continuity corrections. We then use the procedure to analyze the data from 48 comparative trials involving rosiglitazone with respect to its possible cardiovascular toxicity.

Keywords: Continuity correction for zero events; Exact inference procedure; Odds ratio; Risk difference

Received October 31, 2007; revised March 12, 2008; revised May 23, 2008; revised August 14, 2008; accepted for publication September 3, 2008.


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