Medium matters: modeling the impact of solid medium performance on tuberculosis trial sample size requirements.
Journal Article (Journal Article)
SETTING: Two-month solid medium culture conversion is a commonly used, if suboptimal, endpoint for phase 2 anti-tuberculosis treatment trials. OBJECTIVE AND DESIGN: To model the effect of the performance characteristics (sensitivity and contamination rate) of solid medium 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 the 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 the efficiency of tuberculosis clinical trials.
Full Text
Duke Authors
Cited Authors
- Johnson, MG; Stout, JE; Benator, DA; Whitworth, WC; Holland, DP
Published Date
- May 2016
Published In
Volume / Issue
- 20 / 5
Start / End Page
- 600 - 604
PubMed ID
- 27084812
Pubmed Central ID
- PMC4960979
Electronic International Standard Serial Number (EISSN)
- 1815-7920
Digital Object Identifier (DOI)
- 10.5588/ijtld.15.0570
Language
- eng
Conference Location
- France