Media matters: Modeling the impact of solid media performance on tuberculosis trial sample size requirements
Published Date:May 2016
Source:Int J Tuberc Lung Dis. 20(5):600-604.
Pubmed Central ID:PMC4960979
Funding:CC999999/Intramural CDC HHS/United States
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.
Increasing sensitivity and decreasing contamination reduced sample size from 239 subjects/arm (60% sensitivity, 30% contamination) to 138 subjects/arm (95% sensitivity, 1% contamination).
Optimizing solid medium has significant potential to reduce sample size and increase tuberculosis clinical trial efficiency.
Supporting Files:No Additional Files
You May Also Like: