WHO Releases Guidance on Evidence Generation on New Regimens for TB Preventive Treatment
19 December 2025
19 December 2025 | GENEVA — The World Health Organization (WHO) has published today Guidance on evidence generation (GEG) on new regimens for tuberculosis preventive treatment (TPT). This document informs researchers, developers, funders, and other stakeholders about how evidence should be generated to optimally inform WHO guideline development on novel regimens for TPT.
It outlines 22 key messages, explains why they are important, and 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 guidance is a key milestone in our efforts to improve the quality of evidence being generated in support of global efforts to increase the uptake of TPT by those at risk and thus contribute to people-centred care” said Tereza Kasaeva, Director of WHO’s Department for HIV, Tuberculosis, Hepatitis & Sexually Transmitted Infections. “The production of this document was made possible through the contribution of a broad constituency of experts, TB survivors and other partners, to whom WHO is indebted for their continued support.”
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. Action to minimize these limitations can be taken at different stages in the generation of new evidence. The guidance in this document highlights and explains the critical points in the conduct of studies that, based on past experience, can lead to stronger WHO policy recommendations, and eventually better uptake of TPT, to the benefit of those affected by TB.
Source: WHO
