The World Health Organization (WHO) has published today, for the first time, Guidance on evidence generation (GEG) for new tuberculosis diagnostics . This document is the third in WHO’s series of guidance on evidence generation documents, following the GEG for new regimens for tuberculosis treatment and on tuberculosis preventive treatment . The guidance informs researchers, developers, funders and other stakeholders about how evidence should be generated to optimally inform WHO guideline development on new TB diagnostic tests, sample types and testing strategies.
“Robust evidence is the foundation of strong WHO recommendations. This guidance gives researchers, developers and funders a clear road map for generating the evidence WHO needs on innovative tuberculosis tests, sample types and testing strategies, so that better diagnostics reach more people who need them, faster,” said Tereza Kasaeva, Director, Department for HIV, Tuberculosis, Hepatitis and Sexually Transmitted Infections.
The guidance outlines key methodological approaches to provide the strongest evidence base for WHO recommendations. The key messages cover areas such as diagnostic accuracy study design, participant selection criteria, sample size and reporting, as well as how to generate evidence on people-important health outcomes, values, cost–effectiveness, equity, acceptability and feasibility.
The guidance also includes a new analytical framework that maps the role of a diagnostic across the clinical pathway and links that map to key considerations for study design, population, methods and result reporting. This would enable those who aim to contribute to the policy to design and report studies in a way that maximizes their potential to do so.
This guidance document addresses a critical need. Evidence generated for new TB diagnostics has often been insufficient or incomplete: many studies have had methodological limitations, excluded vulnerable populations that could benefit most from the intervention, focused solely on test accuracy, or provided little information on other relevant factors such as feasibility, acceptability, equity or cost. Study results have been reported incompletely or inconsistently, making them difficult to synthesize. The reasons for these challenges are addressable but have not always been well understood by all stakeholders.
Together with WHO’s target product profiles for tuberculosis diagnosis and detection of drug resistance , this new guidance provides a critical foundation for advancing diagnostic innovation and translating scientific evidence into effective policies and practice. By strengthening the quality, relevance and completeness of evidence generated, it will help inform robust WHO recommendations, support faster adoption of new diagnostic technologies and accelerate their uptake in countries.
