i
Media matters: Modeling the impact of solid media performance on tuberculosis trial sample size requirements
-
2016 May
-
-
Source: Int J Tuberc Lung Dis. 20(5):600-604
[PDF-257.92 KB]
Details:
-
Alternative Title:Int J Tuberc Lung Dis
-
Personal Author:
-
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.
-
Subjects:
-
Source:
-
Pubmed ID:27084812
-
Pubmed Central ID:PMC4960979
-
Document Type:
-
Funding:
-
Collection(s):
-
Main Document Checksum:
-
Download URL:
-
File Type:
