4. Research to Translate and Yield Evidence into Practice (ReLAY)

Rationale

The process of translating trial findings into clinical applications is complicated by potential limitations in evidence from various trials and a complex path through regulatory and normative approvals. In view of recent developments, the likelihood of introducing novel TB treatments has substantially increased. To effectively translate new regimens into clinical benefit, research studies should fulfill the needs of national programs and extend their benefits to special populations (e.g. children, pregnant women, people living with HIV) while meeting regulatory and normative requirements. This requires improved communication and collaboration among the many stakeholders engaged in translational research worldwide to overcome challenges and foster a harmonized approach across the research and development pathway. 

Goal and Objective

The goal of ReLAY is to facilitate a research strategy that is informed by a nuanced understanding of real-world needs. To achieve this, ReLAY will foster engagement with regulatory and affected communities and normative bodies as well as those responsible for the introduction of new TB regimens to ensure that research groups working upstream are cognizant of their needs and priorities. 

The specific objectives of RELAY are: 

1. To engage with international stakeholders and communities affected by TB to understand their perspectives and provide the appropriate channel(s) for community input into research prioritization and design; 
2. To identify research priorities that can best inform the introduction of new TB regimens, taking into consideration the needs of end-users in high TB-burden countries; 
3. To serve as a communication platform that enhances interaction among stakeholders involved in clinical research for TB treatment to refine research strategy and ensure that they are aligned with the broader community’s expectations while minimizing gaps. 

Expected Outcome

This effort will foster closer engagement of groups working along the treatment R&D pathway with groups responsible for introducing new TB regimens in care and practice. This includes regulatory bodies to hasten TB drug approvals through streamlined development and accelerated regulatory pathways. In partnership with the research community, key normative institutions, and those who benefit from this work, ReLAY will help prioritize clinical research that aligns with the global realities of TB care and accelerate the introduction of more effective regimens that dramatically improve outcomes for TB patients.