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The World Health Organization is publishing a position statement on Innovative Clinical Trial Designs for Development of New TB Treatments. This document aims to support TB regimen development by highlighting key clinical trial characteristics to help advance novel therapies. It summarises key innovations in TB clinical trial designs, ranging from pharmacokinetic-pharmacodynamic (PK-PD) modelling and new advances in biomarker development to the value of novel clinical trial design methodologies and post-licensure observational studies.
The position statement targets TB drugs and regimens developers including pharmaceutical industry, TB researchers and trialists, preclinical scientists and modellers, and calls for increased collaboration as well as data sharing and integration and standardisation of tools and measurements to advance scientific discovery. It also emphasizes engagement with national TB programmes and affected communities to facilitate the translation of evidence into national and global policies on TB treatment and care.
Innovations in TB drug development and clinical trial design are anticipated to accelerate the development and evaluation as well as facilitate approval of novel regimens to treat all forms of TB and lead to a welcome expansion of the TB drug pipeline.
“The discovery, development and rapid uptake of new tools, interventions, and strategies are critical to substantially reduce TB incidence and reach the global End TB targets” said Dr Tereza Kasaeva, Director, WHO Global Tuberculosis Programme. “This includes shorter, safer and more effective regimens for treating drug sensitive TB and drug resistant TB that can be used in all patient populations, including children, pregnant women, people living with HIV, and other populations at-risk”.
Position statement on innovative clinical trial design for development of new TB treatments
