WHO publishes position statement on innovative clinical trial designs for development of new TB treatments

The World Health Organization (WHO) has published a position statement on innovative clinical trial designs for development of new tuberculous (TB) treatments. The statement 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. For various stages along the development pathway, remaining challenges are described alongside possible solutions to help overcome these issues.

Source: WHO, 19 July 2021