World Health Organization (WHO) partners with UCL to foster collaborative tuberculosis (TB) research

Since 2021, UCL has hosted the TB treatment individual patient data platform (TB-IPD), which helps academia, industry and government co-create innovative TB research and policy.

The records of 42,000 patients with TB are held in the TB-IPD and shared securely with the research and policy community to help them devise the best treatment approaches to the disease – which kills approximately 1.6 million people each year.  

This is a collaboration between the UCL Institute for Global Health and the Medical Research Council Clinical Trials Unit (MRC CTU) at UCL alongside the WHO’s Global TB Programme – with the partnership facilitated by UCL Consultants (UCLC). 

Project co-lead Professor Molebogeng (Lele) Rangaka comments: “The big idea here is open science and keeping the data alive so to speak. Often what happens is, as soon as a research project or trial ends, the data is archived and can be essentially forgotten. 

“But there’s so much more that can be derived from secondary analyses – for example to generate further hypotheses or pool together smaller studies that can then be used to answer pressing questions. In turn that can actually lead to changes in policy, supporting the WHO in delivering impactful recommendations. That’s what’s really driving our team and why we went for this in the first place.”

Increasing the TB knowledge base 

In 2022, approximately 10.6 million people fell ill with TB, while an estimated 2 billion have an asymptomatic latent TB infection putting them at risk of developing active TB during their lifetime. A cornerstone of treatment for active TB is the first-line antibiotic rifampicin. However, in 2022, half a million new cases of rifampicin-resistant TB were reported, with increasing drug resistance among TB patients a growing concern overall. 

The WHO End TB Strategy, includes a Global Action Plan to combat drug-resistant TB. As part of this approach, the WHO announced the TB-IPD in 2021, as a way to increase the knowledge base for guidance on optimal treatment modalities for drug-resistant tuberculosis. The UCL Institute for Global Health was subsequently selected to host the TB-IPD, in an agreement facilitated by UCLC.
The TB-IPD team has now expanded its remit beyond just drug resistant TB, to include drug-sensitive TB for adults as well as children and adolescents. In future the remit will broaden to include outcomes from trials on TB prevention, an area in need of much invigoration.

Prof Rangaka comments: “While there have been some major trials in TB prevention in recent years, things have now become a little stagnant: we have three or four regimens that we are using, but they are still longer in terms of duration than would be ideal and there seem to be no big ideas coming on the horizon. I believe by pulling together all the data we have on TB prevention treatment outcomes we can at least get a sense of how to reimagine the space.”

A Data Safe Haven

The primary purpose of the TB-IPD is to facilitate pooling of individual patient data provided by researchers or local/national TB programmes. Data contributors share data which are stored in the ‘Data Safe Haven’. 

When required, the WHO requests data for guideline development. Other researchers may also make requests for data to the Data Access Committee. Importantly, the data held in the TB-IPD are ‘effectively anonymised’, as defined by the Information Commissioner’s Office of the UK Government, which means that the data contain no personal identifiers and have only a remote risk of being re-identified. The Data Safe Haven is UCL’s technical solution for storing, handling and analysing identifiable data. It is effectively a ‘walled garden’ with all storage and processing of data in a controlled environment with no access to the outside.

Dr Ruth Goodall, Principal Research Fellow at the MRC CTU at UCL (part of the Institute of Clinical Trials and Methodology), co-leads the platform, focusing on the technical implementation of the TB-IPD. She comments:

“I think for our project, the key is building trust. Most people within the TB research community want to share and fully subscribe to the principles of open science; but understandably there’s some nervousness about the actual practicalities because researchers are heavily invested in their own individual studies and datasets. So we’ve spent a lot of time trying to make that as pain-free as possible and we’ve also listened and taken feedback onboard.”

Equity and diversity in data access

Having got underway in 2021, the TB-IPD project is scheduled to run for five years in total. The first two and half years have been spent establishing the legal framework and administrative infrastructure, with more focus recently on engaging potential data requesters and getting data into the community.

Interestingly, Professor Rangaka notes that around half of the requests for data so far have been from pharmaceutical companies, adding: “It’s important for them to get a sense of what's worked and what hasn’t worked in terms of treatment outcomes and why – beyond what is reported in published papers. It could even help them to develop better drugs in the future.”

Overall, the majority of data requesters so far have been from the Global North, where there is more likely to be funding and support for analysis work from dedicated statistics units. Professor Rangaka and team are therefore now thinking about ways to ensure equity and diversity in terms of data access.

“In the next year or so, we’re looking at running a Grand Challenges-type scheme, for example inviting early career researchers from low- and middle-income countries and giving them a small seed fund to present a proposal. If the ideas have traction we will take those forward and support the analysis through the MRC Clinical Trials Unit at UCL.”