Exploring synergies and collaborations

Our Consortium is made up of partner organizations that have led global clinical TB research over the last decade and who have longstanding relationships with important stakeholders in the field. One such partner is the University of Milan (UMIL). Led by Professor Mario Raviglione, the UMIL team is working to ensure adequate early engagement of national and international policymakers, funders, and nongovernmental organizations to enable the effective delivery and dissemination of the project goals and results.

This is being done by (1) mapping, interviewing, and analyzing relevant stakeholders in the TB field - and (2) participating in key TB regional stakeholder events to discuss project findings and advocate for their rapid implementation.

Progress to date

So far, the UMIL team has conducted interviews with 50 stakeholders. These include 33 government agencies (19 national TB programs); nine national and international nongovernmental organizations; five international donors; and three research institutes. In addition, there has been engagement via participation in four WHO regional National TB Programme Managers’ meetings.

Key findings

Several fundamental learnings have emerged, including the following recommendations:

1. In the clinical trial design, ensure to meet the WHO recommended outcomes to develop policies and guidelines 
2. Ensure equitable access to treatment and diagnostic innovations for low- and middle-income countries 
3. Consider the use of fixed-dose combinations and explore with regulatory authorities their approval as drug combinations instead of single drugs
4. Carefully select clinical trial sites to include those with vulnerable populations, drug-resistant TB, the countries with the largest and highest global TB burden
5. Coordinate with other clinical trial research consortia to limit duplications in research and development efforts
6. Engage national TB programs early on to ensure proper selection of clinical trial sites and to build local research capacity
7. Support national TB programs in identifying bottlenecks for their rapid uptake of new regimens, such as approval by national regulatory authorities, procurement and supply management, laboratory capacity, patient support, pharmacovigilance, technical assistance,  funding, engagement of professional associations and civil society
8. Make use of engaged stakeholder organizations to facilitate dialogue among research consortia to coordinate efforts and solve bottlenecks in research and development and policy implementation
9. Advocate with investors and donors for adequate and stable funding of advanced clinical trial phases
10. Ensure effective, regular, and timely information sharing with stakeholders of relevant scientific discoveries emerging from the clinical trials

Commenting on the role of UMIL within UNITE4TB, Professor Raviglione said: “TB is one of the leading causes of death worldwide and public-private collaboration is an ideal model to develop new regimens that can cure people more easily while stopping transmission and preventing drug resistance. The role of UMIL in UNITE4TB is to engage all relevant stakeholders such as policymakers, donors, partners, and national program managers so that equitable access to future TB treatments is ensured for all.”