On September 30-October 1, a consultation with stakeholders on a platform for efficient and pragmatic TB treatment trials was held in Geneva.
Organized by the WHO Global TB Program, this meeting brings together National TB program managers with experienced clinical trialists, trial methodologists, funding partners, regulatory bodies and the community.
The current consultation is expected to be the first step in a series of engagements that will lead to mutually agreed research via a trial platform, generating high-quality evidence to improve treatment outcomes and ultimately leading to the generation of stronger treatment guidelines.
The agenda included discussions on critical aspects, the initial intervention selection pathway, implementation considerations, and governance. The participants discussed specific actions to implement the vision of the trial platform with the goal of establishing an initial listing and possible ranking of the most important research questions. In addition, there will be an outline of some critical considerations regarding trial implementation.
The main goals of the consultation:
· To present to and update key stakeholders about the vision for the platform trial
· To understand the scope of clinical research into TB treatment done in each country
· To discuss key needs that can be addressed in the TB Trial platform
· To obtain input from experienced clinical triallists and methodologists on design and intervention selection
· To understand the regulations surrounding the implementation of a multi-country pragmatic trial
· To discuss concrete actions to operationalise the vision of the TB trial platform.
On the first day of the Consultation, a separate session was devoted to community perspective on key priorities for TB treatment research. Within the framework of this session, TBEC Executive Director Yuliia Kalancha, as a member of the WHO Civil Society Task Force on TB, shared the practical perspective of the meaningful engagement of communities and CSOs in clinical trials, using the example of their remarkable benefit in several recent studies presented last year at the UNION Conference – EndTB, TB-CHAMP и V-QUIN.
"In TB research, the voices of the community and civil society bring a critical perspective. They help evaluate not just clinical outcomes, but the real-world practicality of treatments. It’s one thing to test a drug in a lab; it’s another to live with it daily, in less-than-ideal circumstances. These voices highlight gaps that research can miss, especially around patient experience, access, and long-term adherence. Sometimes, it’s the small details that make all the difference." – the speaker said, - “By involving communities early, we don’t just make the research more robust; we make it more relevant, more equitable, and ultimately more effective. After all, it’s not just about finding a cure—it’s about making sure that cure works for everyone.”
The second day of the meeting is devoted to an open discussion on risk proportionality in a pragmatic TB trial, as well as the participants' work on the next steps.
