Samuel G. Schumacher

Thanks for sharing this Peter, look forward to reading this

Draft document available here: buff.ly/20RW4db

📝 Submit feedback here: buff.ly/bHa1CKk

📣 WHO invites feedback on the draft Guidance on Evidence Generation for TB Preventive Treatment (GEG-TPT) — open for public comment until 1 August 2025.

Help shape future @WHO guidelines on #TB prevention.

WHO Newsflash here:
buff.ly/zaIVweX

WHO launches Public call for individual participant data on on BPaL, BPaLM, BPaLC and BDLC for the treatment of drug-resistant tuberculosis
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Xpert MTB/RIF® cycle threshold as a marker of TB disease severity; Implications for TB treatment stratification Introduction Recent trials have demonstrated that shortened four-month treatment durations are effective for the majority of people with tuberculosis (TB). However, there is a population of TB patient...

NEW PRE-PRINT (currently going through peer review)

In this secondary analysis of the RIFASHORT trial we classified TB disease severity at baseline and show that for the majority of people 4-months of rifampicin-based treatment, without the use of a quinolone, was non-inferior to the 6-month SOC.

Funding acknowledgement:
This work is made possible through catalytic support from the Gates Foundation—thank you for championing better, faster TB diagnostics. #Tuberculosis #Diagnostics #GlobalHealth #EvidenceGeneration #WHO #TBScience #Policy #Research

Kyung Hyun Oh · Jean Iragena · Soudeh Ehsani

Steering-group members:
Patricia Hall-Eidson · Alexei Korobitsyn · Carl-Michael Nathanson· Nazir Ismail · Matteo Zignol · Irena Prat · Dr Kerri Viney · Dennis von Berlepsch · Cecily Miller· Avinash Kanchar · Saskia Den Boon · Vineet Bhatia · Martin van den Boom · Ernesto Montero

Observers
Grania Brigden · Puneet Dewan · Smiljka de Lussigny · Adam Penn-Nicholson · Jacob Creswell · Anisa Ghadrshenas

Gavin Churchyard · Yanlin Zhao · Sabira Tahseen · Chishala Chabala · Alex Kay · Nora Engel · Augusto Geyer · Valeria Alcon · Yemisi Takwoingi · Shaheed Vally Omar · Siva Kumar Shanmugam · Daniela Cirillo · Christopher Coulter · Thomas Shinnick · Monde Muyoyeta · Mikashmi Kohli

Contributors 🙌
Claudia Denkinger · Grant Theron · Madhukar Pai · Mark Nicol · Rachel Louise Byrne · Nandita Venkatesan · Tejaswini DV · Jon Deeks · Achilles Katamba · Alice Zwerling · Hojoon Sohn · Holger Schünemann · Emily L MacLean · Anis Karuniawati

Timeline 🗓️ Draft v0 with the Scientific GEG Development Group this month → iterative inputs mid-2025 → open review → publication by year-end. Stay tuned!

Why it matters👇
• Bridges discovery → policy → impact
• Covers diagnostic accuracy, patient outcomes, costs, equity & feasibility
• Speeds scale-up of cutting-edge tools for people affected by TB.

🌍 WHO kicks off work on the Guidance on Evidence Generation (GEG) for new #TB diagnostics! A clear playbook to help innovators & researchers produce the robust data WHO needs for rapid policy decisions. 🚀 #GlobalHealth #EndTB

Thanks Kyle! Glad it's still useful. Have you had a look at this as well?

www.who.int/news/item/28...

If you are at a loose end next Tuesday, come hear me and @danieljgrint.bsky.social talk about endpoints in TB trials

Hybrid event, in London and online

Most of the same ideas available in written form here
www.thelancet.com/journals/lan...

#IDSky #TBSky @sgschumacher.bsky.social

BEAT Tuberculosis: a randomized controlled trial of a 6-month strategy for rifampicin-resistant tuberculosis Background Safer, more effective treatment regimens for rifampicin-resistant tuberculosis are needed. We evaluated a novel six-month RR-TB treatment strategy. Methods We conducted a phase III,…

JUST PUBLISHED: Results from the BEAT Tuberculosis trial of the 6-month BDLLxC regimen, which supported recently released updated #TB treatment guidelines buff.ly/FX9WdNR
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The potential impact of reductions in international donor funding on tuberculosis in low- and middle-income countries Background Tuberculosis services in many settings rely heavily on international donor funding. In 2025, the United States Agency for International Development (USAID) was dismantled, and other countri...

#Tuberculosis prevention and care relies heavily on international donor funding in many settings. In our latest preprint, we examine the potential impact of reductions in international donor funding for #TB - by the US and by other major donor countries. 1/8

www.medrxiv.org/content/10.1...

Cost analysis of the TB-PRACTECAL clinical trial on novel tuberculosis treatment regimens Clinical trials are considered to be the largest contributor to pharmaceutical development costs. However, public disclosure of the costs of individual clinical trials is rare. Médecins Sans Frontiè...

Just out! journals.plos.org/globalpublic... Clinical trial costs transparency as a tool to facilitate equitable access. A call to action! Please spread the word @msf.ca @madhupai.bsky.social @johngreensbluesky.bsky.social @catherineberry.bsky.social @sgschumacher.bsky.social @cdmitpih.bsky.social

Diagnostic accuracy of swab-based molecular tests for tuberculosis using… | Seda Y. The R2D2 TB Network Consortium has just released a preprint on the first-ever study evaluating the diagnostic accuracy of novel near-point-of-care MTB assays using tongue and sputum swabs for tubercul...

www.linkedin.com/posts/activi...

Global Drug Facility Announces Another Big Price Drop: 25% Reduction in… | Samuel G. Schumacher GOOD NEWS: 25% price reduction for pretomanid - price of a BPaLM treatment course is now $310. The vast majority of DR-TB patients should be able to benefit from this shorter, more effective regimen n...

GOOD NEWS: 25% price reduction for pretomanid - price of a BPaLM treatment course is now $310. The vast majority of DR-TB patients can benefit from this shorter, more effective regimen now. And it is cost-saving to health systems. Countries should transition away from other options rapidly.

· establishes two new classes of TB diagnostic technologies for the initial detection of TB and resistance to rifampicin, and

· outlines current WHO TB diagnostic class determination and product assessment definitions and pathways

· presents new recommendations on concurrent testing of respiratory and non-respiratory samples among people of all ages living with HIV and children without HIV or with unknown HIV status
...

WHO launches an update on the consolidated guidelines to diagnose tuberculosis. This consolidated document:
· combines the WHO policy guidance on diagnosis of TB infection, disease and drug resistance into a single reference document
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WHO launches an update on the consolidated guidelines to diagnose #tuberculosis
createsend.com/t/d-CCE83795...

These consolidated guidelines bring together all WHO guidelines related to treatment, combining previously separate documents on the treatment of drug-susceptible TB, drug-resistant TB and TB care & support.

These new recommendations are based on recent clinical trials, including the BEAT-Tuberculosis Trial (South Africa, NCT04062201), and endTB Clinical Trial (NCT02754765), which provided evidence supporting the WHO review.

JUST RELEASED: updated WHO TB treatment guidelines, including a recommendation for one new 6m and 3 new 9m regimens for DR-TB:
createsend.com/t/d-0CC16B59...

Did you miss @tb-lshtm.bsky.social & @ucltb.bsky.social Symposium? Or would you like to watch again? Good news: the full recording is now available! tinyurl.com/bdh8fymx
@sedonasweeney.bsky.social @kchorton.bsky.social @reinhouben.bsky.social

Guidance for best practices for clinical trials This guidance updates and adapts the previous work of the World Health Organization (WHO) on research capacity for the context of well-designed and well-implemented clinical trials as framed in…

The recently published WHO Guidance for best practices for clinical trials and the WHO Global Clinical Trials Forum are key to move this forward.
www.who.int/publications...