Keeping phase III tuberculosis trials relevant: Adapting to a rapidly changing landscape - PubMed (original) (raw)

Review

Keeping phase III tuberculosis trials relevant: Adapting to a rapidly changing landscape

Patrick P J Phillips et al. PLoS Med. 2019.

Abstract

In a Collection Review, Patrick Phillips and colleagues discuss developments in clinical trial design for the evaluation of TB therapeutics.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1

Fig 1. Illustration of the results of a noninferiority trial with a 6% margin of noninferiority (represented by the shaded area to the left of 6%), data from the RIFAQUIN trial [5].

The findings for two drug regimens are illustrated by point estimates of efficacy surrounded by 90% confidence intervals from the per protocol analysis. In this example, the 6-month regimen is noninferior to control because the upper bound of the confidence interval is less than the 6% margin of noninferiority. However, the 4-month regimen is not noninferior to the control because the upper bound exceeds the margin of noninferiority.

References

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