Exact Inference for Common Odds Ratio in Meta-Analysis with Zero-Total-Event Studies

Stemming from the high profile publication of Nissen and Wolski (2007) and subsequent discussions with divergent views on how to handle observed zero-total-event studies, defined to be studies which observe zero events in both treatment and control arms, the research topic concerning the common odds ratio model with zero-total-event studies remains to be an unresolved problem in meta-analysis. In this article, we address this problem by proposing a novel repro samples method to handle zero-total-event studies and make inference for the parameter of common odds ratio. The development explicitly accounts for sampling scheme and does not rely on large sample approximation. It is theoretically justified with a guaranteed finite sample performance. The empirical performance of the proposed method is demonstrated through simulation studies. It shows that the proposed confidence set achieves the desired empirical coverage rate and also that the zero-total-event studies contains information and impacts the inference for the common odds ratio. The proposed method is applied to combine information in the Nissen and Wolski study.