ExpectedOutcome:
This topic aims at supporting activities that are contributing to one or several of the expected impacts for this call. To that end, proposals under this topic should aim for delivering results that are directed towards and contributing to the following expected outcomes:
- A well-documented overview of operational and effective regional clinical trial and laboratory networks in different clinical settings in sub-Saharan Africa, and the existing coordination mechanisms within and between the networks, is developed;
- An efficient coordination and collaboration mechanism between identified clinical trial and laboratory networks in sub-Saharan Africa is established and sustained;
- The foundation for a coordinated, permanent, pan sub-Saharan African clinical trial infrastructure to optimise a coordinated response to infectious diseases threats, including emerging infections, is laid, taking advantage of the existing EDCTP’s Networks of Excellence;
- The role of Africa in clinical research preparedness for future epidemics and pandemics is strengthened.
Scope:
The work carried out under this topic should lay the foundation for the establishment of a pan sub-Saharan African infrastructure of clinical trial facilities that continuously evaluate health interventions (incl. vaccines, treatments and diagnostics) for infectious diseases in a coordinated, harmonized manner to maximize trial efficiency. Such an infrastructure should leverage the work done by EDCTP Networks of Excellence[1] through interaction with these networks. It should also be capable of quickly and easily adapting ongoing clinical trials for vaccines, treatments or diagnostics to tackle emerging infectious disease threats, if and when the need arises.
The purpose of this topic is to support one project which will carry out a desk review and mapping exercise of the current landscape of clinical trial and laboratory networks in sub-Saharan Africa. Such an exercise would provide the basis for the creation of the intended network. The network could be composed of regional networks in Sub-Saharan Africa, each regional network with its connected clinical trial sites and laboratories. The structure to be built needs to ensure a harmonised approach to clinical trial implementation.
Relevant regional and international organisations, such as the World Health Organization - Regional Office for Africa, the African Medicines Agency (AMA) or the Africa Centre for Disease Control and Prevention (Africa CDC), should be consulted when developing the plans for the future network.
Proposals should address the following areas:
- Conducting a mapping exercise to analyse the operational and effective clinical trial and laboratory networks in different clinical settings in sub-Saharan Africa, including their related coordination mechanisms;
- Establishing a clinical trial network, possibly composed of sub-networks in sub-Saharan Africa, under which the clinical sites and laboratories will collaborate and coordinate their activities. The network(s) should work in close collaboration EDCTP’s Networks of Excellence[2] and take into account the work and operational network infrastructure established by the Networks of Excellence;
- Planning for common preparedness research approaches and tools within the network(s), such as clinical trial protocols including master protocols, as well as a comprehensive data management framework allowing the collection, storage, analysis and sharing of standardised data between relevant clinical sites and laboratories;
- Developing an electronic registry of trial sites and laboratories, covering relevant information on their capacity to implement clinical trials, as a tool to enable large-scale trials;
- Establishing a strong coordination and collaboration mechanism to support the harmonization of clinical trials across the sub-Saharan African infrastructure of clinical trial facilities;
- Coordinating and collaborating with relevant other initiatives including those funded by previous EDCTP programmes such as the epidemic preparedness and response research networks ALERRT[3] and PANDORA[4], to avoid duplication of activities and ensure complementarity;
- Developing a business plan for operationalising the pan sub-Saharan infrastructure of clinical trial facilities that continuously evaluate health interventions (incl. vaccines, treatments and diagnostics) for infectious diseases in sub-Saharan Africa and which, in case of a health threat, are able to quickly and easily adapt to tackle such threat;
- This business plan should be developed through consultation with relevant African stakeholders, such as representatives from regulatory authorities, industry, policy makers, patient organisations, etc., as well as relevant European trial coordinators and stakeholders;
- Promoting the visibility and attractiveness of the future infrastructure for investigators and sponsors of clinical trials in infectious diseases; as well as active communication with the science community, patient advocacy groups and other stakeholders.
Cross-cutting Priorities:
AfricaInternational CooperationSocial sciences and humanities
[1]https://www.edctp.org/our-work/edctp-regional-networks-of-excellence/
[2]http://www.edctp.org/our-work/edctp-regional-networks-of-excellence/
[3]https://www.alerrt.global/
[4]https://www.pandora-id.net/
