Sequential generalized likelihood ratio tests for vaccine safety evaluation

The evaluation of vaccine safety involves pre‐clinical animal studies, pre‐licensure randomized clinical trials, and post‐licensure safety studies. Sequential design and analysis are of particular interest because they allow early termination of the trial or quick detection that the vaccine exceeds...

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Bibliographic Details
Published in:Statistics in medicine 2010-11, Vol.29 (26), p.2698-2708
Main Authors: Shih, Mei-Chiung, Lai, Tze Leung, Heyse, Joseph F., Chen, Jie
Format: Article
Language:English
Subjects:
Algorithms
Animal vaccines
Clinical trials
Clinical Trials as Topic
Drug-Related Side Effects and Adverse Reactions
generalized likelihood ratio tests
Humans
Immunization
Likelihood Functions
Medical statistics
Ratios
rotavirus
Rotavirus - drug effects
Safety Management
sequential probability ratio test
Side effects
Simulation
vaccine safety
Vaccines - adverse effects
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Summary:The evaluation of vaccine safety involves pre‐clinical animal studies, pre‐licensure randomized clinical trials, and post‐licensure safety studies. Sequential design and analysis are of particular interest because they allow early termination of the trial or quick detection that the vaccine exceeds a prescribed bound on the adverse event rate. After a review of the recent developments in this area, we propose a new class of sequential generalized likelihood ratio tests for evaluating adverse event rates in two‐armed pre‐licensure clinical trials and single‐armed post‐licensure studies. The proposed approach is illustrated using data from the Rotavirus Efficacy and Safety Trial. Simulation studies of the performance of the proposed approach and other methods are also given. Copyright © 2010 John Wiley & Sons, Ltd.
ISSN:0277-6715
1097-0258
DOI:10.1002/sim.4036