The Portuguese-speaking African Countries (PSACs) – Angola, Cape Verde, Guinea-Bissau, Mozambique, and São Tomé and Príncipe – face persistent challenges in establishing robust ethical and legal frameworks for the regulation and conduct of clinical trials (CTs). These include legislative gaps, institutional fragilities, a shortage of qualified professionals, and the absence of consolidated oversight procedures.
In this context, marked by the global need to strengthen health systems and promote international cooperation in biomedical research, CT-Luso aims to build the ethical, legal, and institutional capacity of the PSACs to integrate responsibly into international clinical research networks.
The project adopts a systemic and integrated approach, reinforcing legislative, institutional, professional, and procedural capacities, while engaging political stakeholders to ensure sustainability and the protection of research participants.
Its overarching goal is to establish a Lusophone Clinical Trials Cluster, capable of submitting, evaluating, and implementing research protocols according to international best practices – attracting investment, optimising resources, and improving the quality of biomedical research.
CT-Luso’s objectives:
- Short-term: reinforce and harmonise ethical and legal frameworks for CTs, strengthen institutional efficiency, and enhance professional competencies to achieve international recognition of research quality;
- Medium-term: establish a Community of Practice (CoP) connecting ethics and regulatory professionals, researchers, and policymakers to foster collaboration and integration into global networks;
- Long-term: build a sustainable Lusophone Clinical Trials Cluster, enabling Portuguese-speaking African Countries to lead and participate in global biomedical research.
