Tools to facilitate the R&D infrastructure
With the input of the TB vaccine community, a team of scientific and technical experts from TBVI and IAVI established the ‘TB Vaccine Development Pathway’, a tool developed on behalf of the Global TB Vaccine Partnership (GTBVP). The Pathway serves as a guidance tool to help vaccine developers consider all the functions of development and to advance a vaccine to its next stage of development (www.TBvacpathway.com).
On behalf of EDCTP, TBVI together with experts developed and established a set of guidance documents and web-based tools as well as a comprehensive registry of trial sites in sub-Saharan Africa with capacities to conduct TB vaccine studies. To promote collaboration among EDCTP funded actions, TBVI also organises stakeholder meetings and knowledge sharing activities with the broader TB vaccine research community in Africa and Europe.
The set of guidance is coherent with the defined stages and gates (www.TBvacpathway.com) and aligned with other similar ongoing activities such as the EDCTP Knowledge Hub:
- The clinical trial protocol provides guidance for TB vaccine clinical trial design and to establish a repository of clinical trial protocols for TB vaccine trials. It is a general protocol that includes sub-templates with specific considerations for TB vaccine trials with different targets and types of vaccines.
- A Regulatory plan defines the regulatory strategy applicable to the TB vaccine candidate. It outlines the path to follow to obtain regulatory approval. The standard template for a regulatory plan includes directions on how to draft a regulatory plan and provides considerations and information about the approval process of a TB vaccine. It includes guidance and advice on a more strategic level for different stages of the development path that could be taken into account by developers.
- A Data management plan presents all key activities conducted by the data management team and the contribution of other relevant functional groups that support the data management processing activities. The data management plan guidance documents include recommendations whereas the template offers practical support for developing a data management plan.
- The Directory of TB vaccine clinical trial sites in sub-Saharan Africa provides a comprehensive overview of trial sites and their capacity to conduct studies on TB vaccines in sub-Saharan Africa. The directory contains information on site geography, clinical trial capacity, diagnostic capacity, research capacity, demographics, and other relevant areas: Map with the clinical trial site centres Publication: The TB vaccine clinical trial centre directory