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1000
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Abstract/Summary
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SUMMARY POINTS: (*) Preclinical models of tuberculosis have significant limitations in selecting composition and duration of regimens for tuberculosis. (*) Innovative early-phase clinical trial methodologies and technologies have the potential to reduce risk and accelerate drug development in tuberculosis. (*) Phase IIA monotherapy studies are optional for proof of concept but may be useful for dose-finding in conjunction with pharmacokinetic–pharmacodynamic methods. (*) Innovative Phase IIB designs are increasingly common in tuberculosis drug development, utilising multiarm selection designs, sometimes in an adaptive format. (*) Novel biomarkers including liquid culture and nucleic acid amplification appear capable of replacing conventional solid culture in early-phase development. (*) Phase IIC and ultrashort noninferiority designs attempt to mitigate the problem of estimating duration of treatment regimens from Phase II results alone.
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