WHO position statement on innovative clinical trial designs for development of new TB treatments
The World Health Organization (WHO) 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”.
Source:
World Health Organization
