SINCEP-Africa

The challenge

Although Africa has traditionally conducted only a small proportion of the world’s clinical trials, recent years have seen a significant uptick in clinical research activity in the region. Nevertheless, there remain areas for further improvement. Furthermore, as experienced during the COVID-19 pandemic, it is challenging for clinical trial sites in sub-Saharan Africa to rapidly launch trials when outbreaks are detected.

To react quickly, clinical trial sites need to be well-prepared in terms of infrastructure and human capacity. Successful and rapid clinical studies require the right infrastructure, trained staff, baseline data, and pre-approved research protocols. However, as outbreaks are difficult to predict, trial sites may also need to remain active to ensure they are always ready to respond.

Networking among clinical trial sites is important to ensure activities are harmonised and to enable data pooling to generate evidence more promptly. Moreover, because outbreaks may be restricted to particular geographic areas, sites in multiple locations need to be ‘research-ready’. The INDEPTH Network is a well-established consortium of 16 sites in Africa that conduct ongoing health and demographic surveillance and regular systematic data collection from local populations. An opportunity exists to build on this foundation to create additional trial-ready sites.

The project

The SINCEP-Africa project is working with INDEPTH Network partners in sub-Saharan Africa to strengthen their capacity to carry out clinical research during disease outbreaks. The project will include 14 existing INDEPTH sites in the region plus two new sites in Côte d’Ivoire and the Democratic Republic of the Congo (DRC). 

The project will first audit the sites’ ongoing surveillance activities to identify any gaps that need to be addressed to enable clinical research studies to be carried out. Surveillance activities in routine healthcare will be strengthened, and sites’ capacity for clinical research will be reinforced through training and infrastructure upgrades as required. Around 500 academics and trial support staff will benefit from a mix of short-term and long-term training opportunities, including 40 graduate students, 15 PhD students and 10 postdoctoral fellows.

Laboratory capacity for diagnostics and other key technologies will be strengthened where necessary in collaboration with international partners. Laboratory quality management systems will be introduced where needed, and accreditation plans will be developed, with at least five laboratories due to be accredited through the project. In collaboration with national regulatory authorities, the project will also strengthen intervention safety-monitoring systems at the sites.

In addition, the project will introduce an AI-driven electronic surveillance system across participating sites. This will automatically share data with a central database for analysis. This system will be used to develop predictive models that generate insights to guide local decision-making and disease-control activities.

To launch research studies rapidly during outbreaks, clinical trial protocols need to be approved in advance. The project is therefore engaging with national and regional bodies, including ministries of health, national regulatory authorities and research ethics committees, to build support for research and gain pre-approval of master protocols for outbreak-linked clinical studies. This work is being organised in partnership with the African Vaccine Regulatory Forum (AVAREF) and the EDCTP-funded LusoAfro-BioEthics project.

To ensure that trial sites remain ‘warm’ between outbreaks, the project will seek opportunities to host clinical studies of interventions for malaria, TB, HIV/AIDS, and diarrhoeal diseases. The project team is engaging with potential trial sponsors to highlight opportunities the network offers for multicentre trials. 

Impact

The SINCEP-Africa project will make a significant contribution to clinical research capacity building in sub-Saharan Africa. It will:

• Extend the work of existing high-quality health surveillance and research sites so that they can take part in clinical trials.
• Create a network of sites able to rapidly initiate clinical research when disease outbreaks occur.
• Provide an integrated data management and analysis infrastructure for generating actionable insights from site surveillance data.
• Extend the range of sites capable of carrying out research on interventions for the key poverty-related infectious diseases affecting sub-Saharan Africa.

Collectively, project activities will establish a major new clinical trial network in sub-Saharan Africa, significantly expanding clinical trial capacity in the region and creating sites able to respond swiftly during outbreaks to generate evidence on vaccines, therapeutics, and other interventions important for disease control.