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Media matters: Modeling the impact of solid media performance on tuberculosis trial sample size requirements
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Published Date:
2016 May
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Source:Int J Tuberc Lung Dis. 20(5):600-604
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Language:English
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Details:
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Alternative Title:Int J Tuberc Lung Dis
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Personal Author:
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Description:Setting Two-month solid media culture conversion is a commonly used (if suboptimal) endpoint for phase 2 tuberculosis treatment trials. Objective and Design To model the effect of solid media performance characteristics (sensitivity and contamination rate) on required sample size for a two-arm clinical trial with 85% true (gold standard) culture conversion in the control and 95% in the experimental arm. Results Increasing sensitivity and decreasing contamination reduced sample size from 239 subjects/arm (60% sensitivity, 30% contamination) to 138 subjects/arm (95% sensitivity, 1% contamination). Conclusion Optimizing solid medium has significant potential to reduce sample size and increase tuberculosis clinical trial efficiency.
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Subject:
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Pubmed ID:27084812
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Pubmed Central ID:PMC4960979
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