Global Tuberculosis Community Advisory Board (TB CAB)
About
The Global Tuberculosis Community Advisory Board (TB CAB) is a group of strong, research-literate community activists from HIV and TB networks in Asia, Europe, Africa, and North and South America. Founded in 2011, the TB CAB acts in an advisory capacity to:
- product developers and institutions conducting clinical trials of new TB drugs, regimens, diagnostics and vaccines; and
- provide input on study design, early access, regulatory approval, post marketing, and implementation strategies.
The TB CAB is dedicated to increasing community involvement in TB research and access to tools to fight TB and mobilizing political will.
Governance
TB CAB members convene at least once annually for an in-person meeting and hold regular teleconferences. TB CAB members are chosen so as to represent the diverse needs, interests, and concerns of the entire spectrum of the TB and HIV patient community. For those interested in following the work of the TB CAB and staying up to date on TB issues, please subscribe to the TB Online Weekly Newsletter.
For more details on governance of the TB CAB, please see the Terms of Reference.
Position papers/statements
- Response to Tuberculosis Treatment Trials Results Published and Presented During the 2022 Union World Conference on Lung Health (2022)
- TB CAB Access Considerations Statement Regarding Johnson & Johnson Announcement of Bedaquiline Price Reduction (2020)
- Statement by the Global TB Community Advisory Board to the High-level consultation on accelerating the development of the M72/AS01E tuberculosis vaccine candidate (2019)
- TB CAB statement on safety of using bedaquiline and delamanid together (2019)
- The TB CAB and TAG welcome WHO recommendation of injectable-free regimens for the treatment of RR/MDR-TB (2018)
- Global TB CAB welcomes introduction of safer drug for most South Africans with rifampicin-resistant TB (2018)
- The World Health Organization must recommend bedaquiline as part of the preferred regimen for MDR-TB: A position statement from the Global TB CAB (2018)
- The Global TB CAB's proposed development pathway for regimens to treat XDR-TB (2017)
Reports
Activities
2016
- Reviewed clinical trial protocols for TB treatment research
- Appealed to the Ministry of Health in Peru to take steps necessary to facilitating access to delamanid
- Advocated for the establishment of a World Health Organization (WHO) Model List of Essential Diagnostics (EDL)
- Called on Otsuka and Janssen to improve the availability and affordability of delamanid and bedaquiline
- Pushed the WHO, the US Agency for International Development (USAID), and the Global Fund to Fight AIDS, Tuberculosis and Malaria to improve the technical assistance provided by the regional Green Light Committees (rGLCs)
- At the TB2016 pre-conference to International AIDS Conference, presented an oral abstract on the CAB's lessons learned from reviewing TB clinical trials protocols
- Pushed Johns Hopkins University to openly license the rights to develop sutezolid to the Medicines Patent Pool (MPP)
- Urged the Drugs Controller General of India (DCGI) to withdraw the marketing authorization granted to Epistem's GeneDrive – a test with limited utility and high potential for misuse in the Indian market
- Called on the University of Limpopo, Sefako Makgatho Health Science University, and the South African Medical Research Council to expedite the NExT study, which will evaluate an all-oral bedaquiline-containing treatment shortening regimen for MDR-TB
- Encouraged country programs to roll-out urine-based LAM testing for people with HIV with low CD4 counts in Côte D'Ivoire and other African countries with high TB/HIV burdens
- Met in Durban, South Africa (Meeting report) and Liverpool, the United Kingdom (Meeting report; photos)
2015
- Appealed to Vertex to commit to the timely, collaborative, and responsible development of VXc-486 for TB
- Called on the Global Plan Development Task Force to include R&D funding targets in the Global Plan to Stop TB, 2016–2020
- Continued to call on Janssen to reduce the price of bedaquiline for low- and middle-income countries
- Pressed the World Trade Organization to allow extensions for least-developed countries under the TRIPS agreement
- Urged Johns Hopkins University to include time bound development and access requirements in the licensing agreement of sutezolid to Sequella
- Advocated for the addition of bedaquiline, linezolid, rifapentine, and delamanid to the World Health Organization’s Model Essential Medicines List (EML)
- Met in New York, NY (Meeting report; photos) and Cape Town, South Africa (Meeting report)
2014
- Advocated for the TB Alliance to establish a compassionate use program for pretomanid
- Reviewed clinical trial protocols for TB treatment research
- Pressed Johnson & Johnson’s Janssen to reduce the lower- and middle-income country prices for bedaquiline
- Advocated for regulatory authorities and trial coordinators and co-sponsors to revise the design of stage II of the STREAM trial, which will also serve as the phase III confirmatory safety and efficacy trial for bedaquiline
- Pressed Cepheid to further reduce barriers to access to GeneXpert system
- Advocated for independence of Kochon prize from the World Health Organization’s influence and politics
- Submitted feedback to FDA on draft Guidance for Industry – Pulmonary Tuberculosis: Developing Drugs for Treatment
- Pressed Otsuka to expand access to delamanid
- Worked to expand access to linezolid in South Africa
- Advocated for increased investment in TB research and development
- Initiated work with the Union to facilitate increased community participation in future conferences
- Met in New York, NY (Meeting report; photos) and Barcelona, Spain (Meeting report; photos).
2013
- Reviewed clinical trial protocols for TB treatment research
- Encouraged the EMA to approve bedaquiline and delamanid
- Pressed Otsuka to make delamanid available under compassionate use
- Participated in a campaign to reduce the cost of rifapentine in the U.S.
- Urged diagnostic developers to ensure responsible marketing and access (here and here)
- Supported India's refusal of TRIPS-Plus provisions in trade negotiations
- Led action at Union World Conference on Lung Health for accountability to resolve ongoing drug stock-outs in India
- Met in New Delhi, India (Meeting report; photos) and Paris, France (Meeting report; photos)
2012
- Reviewed clinical trial protocols for TB treatment research
- Encouraged the FDA and EMA to harmonize their guidance on accepted endpoints for drug trials
- Urged drug sponsors and regulators to ensure that bedaquiline and delamanid are safe to use in combination, as they likely will be used together in the field
- Advocated for pre-approval access to novel TB drugs for select providers to administer them to patients with no other treatment options (here and here)
- Advocated for GeneXpert system price reduction to expand access to rapid TB diagnosis
- Met in Durban, South Africa and Kuala Lumpur, Malaysia (Meeting report)
2011
- TB CAB founded
- TBOnline.info developed
- First meeting held with key TB drug developers in Washington, D.C. (Meeting report)