The World Health Organization (WHO) has published Guidance on evidence generation (GEG) on new regimens for tuberculosis treatment . This first-of-its-kind document informs researchers, developers, funders, and other stakeholders about how evidence should be generated to optimally inform WHO guideline development on novel regimens for TB treatment. It outlines 21 key messages, explains why they are important, and details what approaches can increase the chances of research leading to strong WHO recommendations. The key messages cover areas such as trial design, selection criteria, outcome choice, sample size, analytic and economic considerations, and how to investigate the impact of an intervention on health equity, acceptability, and feasibility.
"This document provides a clear direction for funders, developers, and researchers about how trials and other studies should be designed to have the greatest possible impact – to change policy, practice and ultimately people-cantered care" said Tereza Kasaeva, Director of WHO's Global Tuberculosis Programme. "WHO thanks the broad constituency of experts, TB survivors and other partners who contributed to their development."
The evidence available to WHO for use in guideline development has often presented challenges that have limited the strength of recommendations and their applicability to certain population groups or have meant that the evidence is not suitable for policy development. The reasons for these challenges are addressable but are not always well understood by all stakeholders. The guidance provided in the GEG document should allow those who aim to influence policy to design trials and other studies in a way that maximizes the potential to do so.
Following the guidance provided in the GEG and the target regimen profiles for tuberculosis treatment should lead to stronger WHO policy recommendations, and faster uptake, ultimately benefitting those affected by TB through better treatment options.
