CT-Luso

The challenge

Strengthening ethical review and regulatory capacity has been a priority for multiple countries in sub-Saharan Africa. As well as protecting the interests of research participants, capacity building will also ensure that countries can offer an attractive environment for conducting clinical research.

Portuguese-speaking countries in sub-Saharan Africa, however, have long been at a disadvantage, because most training materials have been developed in English (or occasionally French). Only limited resources have been produced in or translated into Portuguese. Although stakeholders from these countries have been part of multiple EDCTP capacity-building projects, language barriers prevent them from fully benefiting from such activities.

The EDCTP2-funded BERC-Luso project made a significant contribution to developing the capacity of Portuguese-speaking countries in sub-Saharan Africa. All five such countries now have national research ethics committees and national regulatory agencies, although their maturity varies significantly. 

The project

The CT-Luso project is correcting this imbalance, working with all five Portuguese-speaking countries in sub-Saharan Africa – Angola, Cabo Verde, Guinea-Bissau, Mozambique, and São Tomé and Príncipe – to strengthen ethical review and regulatory capacity, and to create opportunities for networking for mutual benefit.

Bringing together 16 institutions across the five countries (plus partners from Europe), the project is undertaking a landscaping analysis to assess deviations from gold-standard practices and the functional maturity of national regulatory agencies (NRAs) and national research ethics committees. Based on these assessments, advanced training will be provided to close knowledge gaps and promote best practices. 

National development roadmaps will be developed for each country, focusing on areas such as strengthening national legislation when necessary, and building the capacity of national regulatory agencies, research ethics committees and individual researchers. 

The project is working with stakeholders in each country to co-develop the required legislation, development plans and training opportunities. A total of 28 representatives from the five countries, appointed by each country according to their professional specialities, will receive certified post-graduate education and training. A further 100 researchers will receive less intensive training. 

Over the medium term, the project team aims to establish the foundation for a cross-country community of practice, connected to regional and global networks. Online discussion forums will support interactions between stakeholders in different countries.

In the long term, the project aims to establish a cluster of countries adopting common practices to attract additional clinical research projects. The project has been engaging political leaders, including ambassadors, from the outset to promote collaboration and capacity-building.

Impact

The CT-Luso project will provide a major boost to clinical research in Portuguese-speaking countries in sub-Saharan Africa. It will:

• Strengthen the legislative basis for clinical research governance in each country.
• Create a cadre of highly trained professionals with expertise in clinical research governance.
• Establish a wider pool of professionals and researchers with knowledge of research oversight and ethical good practice.
• Strengthen and harmonise processes across all five countries. 

Collectively, these activities will make Portuguese-speaking countries in sub-Saharan Africa a more attractive location for clinical studies, ultimately increasing the number of studies conducted in these countries.