Periodic Reporting for period 1 - CT-Luso (Ethics and Regulatory Capacity Building Partnership for Clinical Trials in Portuguese-speaking African Countries)
Período documentado: 2024-09-01 hasta 2025-08-31
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.
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.
During the first reporting period (September 2024 – August 2025), CT-Luso achieved significant progress toward its scientific, educational, and regulatory objectives.
Key achievements include:
- Work Package 1 – Coordination and Management: Deliverables D1.1 (Quality Management Plan, Open Science Strategy, and Intellectual Property Rights) and D1.2 (Data Management Plan) were submitted in February 2025. Together, they define principles of governance, scientific integrity, and data management, ensuring efficient coordination across all Work Packages. The project’s Kick-off Meeting took place in April 2024 (Maputo).
- Work Package3 – Legislative and Institutional Mapping: Deliverables D3.1 (Legislation Dossier) and D3.2 (Organisational Charts) were completed in February 2025, offering a comprehensive overview of national ethical and regulatory frameworks across the PSACs. The analysis identified key legislative gaps and set priorities for harmonisation and reform.
- Work Package 4 – Education and Training Programme: The interdisciplinary course “The Ethical and Legal Requirements for the Development of Scientific and Clinical Research” trained 234 professionals, far exceeding the target of 130. The training addressed topics such as science and ethics, research integrity and good clinical practice, international bioethics guidelines, public health and infectious diseases, biobanks and responsible research, and regulatory affairs. It was supported by a digital platform (D4.1) launched in December 2024. Deliverables D4.2 (Training Programme Results) and D4.3 (Complementary Programme) were completed in July 2025.
- Work Package8 – Communication and Dissemination: The project’s communication channels - the website (www.ct-luso.com) and LinkedIn page - were launched, and the Plan for the Exploitation and Dissemination of Results, including Communication Activities (D8.1) was submitted in February 2025. CT-Luso was represented at two major international events, the 82nd FIP World Congress (Cape Town, 2024) and the 25th European Conference on Pharmaceutics (Porto, 2025), where the project’s initial results were presented to the international scientific community. In addition, two scientific articles based on the outcomes of WP3 and WP4 were submitted for publication.
All deliverables and milestones planned for this period were achieved on schedule, providing a solid basis for the next phase focused on advanced and practice-based training (WP5–WP7).
Key achievements include:
- Work Package 1 – Coordination and Management: Deliverables D1.1 (Quality Management Plan, Open Science Strategy, and Intellectual Property Rights) and D1.2 (Data Management Plan) were submitted in February 2025. Together, they define principles of governance, scientific integrity, and data management, ensuring efficient coordination across all Work Packages. The project’s Kick-off Meeting took place in April 2024 (Maputo).
- Work Package3 – Legislative and Institutional Mapping: Deliverables D3.1 (Legislation Dossier) and D3.2 (Organisational Charts) were completed in February 2025, offering a comprehensive overview of national ethical and regulatory frameworks across the PSACs. The analysis identified key legislative gaps and set priorities for harmonisation and reform.
- Work Package 4 – Education and Training Programme: The interdisciplinary course “The Ethical and Legal Requirements for the Development of Scientific and Clinical Research” trained 234 professionals, far exceeding the target of 130. The training addressed topics such as science and ethics, research integrity and good clinical practice, international bioethics guidelines, public health and infectious diseases, biobanks and responsible research, and regulatory affairs. It was supported by a digital platform (D4.1) launched in December 2024. Deliverables D4.2 (Training Programme Results) and D4.3 (Complementary Programme) were completed in July 2025.
- Work Package8 – Communication and Dissemination: The project’s communication channels - the website (www.ct-luso.com) and LinkedIn page - were launched, and the Plan for the Exploitation and Dissemination of Results, including Communication Activities (D8.1) was submitted in February 2025. CT-Luso was represented at two major international events, the 82nd FIP World Congress (Cape Town, 2024) and the 25th European Conference on Pharmaceutics (Porto, 2025), where the project’s initial results were presented to the international scientific community. In addition, two scientific articles based on the outcomes of WP3 and WP4 were submitted for publication.
All deliverables and milestones planned for this period were achieved on schedule, providing a solid basis for the next phase focused on advanced and practice-based training (WP5–WP7).
CT-Luso goes beyond existing initiatives by integrating legal harmonisation, institutional strengthening, and professional capacity-building into a single, coherent framework for biomedical research governance. CT-Luso combines these components into a scalable, replicable model for ethical and regulatory reform, adaptable to other African regions.
The legislative and institutional mapping (WP3) generated a comparative diagnostic framework of ethics and regulatory systems across the five PSACs. This tool identifies legislative gaps, clarifies functional relations between NRAs and RECs, and provides an evidence-based foundation for policy alignment and future law revision.
The interdisciplinary training programme (WP4) set a benchmark for ethics and regulatory education in Lusophone Africa. It trained 234 professionals and established a network of qualified experts spanning regulatory authorities, universities, and research centres – the nucleus of a sustainable Community of Practice (CoP).
A distinctive innovation of CT-Luso is its linguistic inclusivity: all materials and resources are made available in Portuguese, ensuring accessibility and ownership by national professionals.
By providing open-access materials through its digital platform and website, CT-Luso contributes directly to Open Science, transparency, and equitable knowledge transfer.
The early outcomes of CT-Luso demonstrate its potential to:
- Enable harmonised and efficient ethics and regulatory review processes;
- Strengthen scientific governance and the adoption of international standards (ICH-GCP);
- Enhance the attractiveness of PSACs for research investment and partnerships;
- Lay the foundation for a Lusophone Clinical Trials Cluster fostering sustainable African-European collaboration.
The legislative and institutional mapping (WP3) generated a comparative diagnostic framework of ethics and regulatory systems across the five PSACs. This tool identifies legislative gaps, clarifies functional relations between NRAs and RECs, and provides an evidence-based foundation for policy alignment and future law revision.
The interdisciplinary training programme (WP4) set a benchmark for ethics and regulatory education in Lusophone Africa. It trained 234 professionals and established a network of qualified experts spanning regulatory authorities, universities, and research centres – the nucleus of a sustainable Community of Practice (CoP).
A distinctive innovation of CT-Luso is its linguistic inclusivity: all materials and resources are made available in Portuguese, ensuring accessibility and ownership by national professionals.
By providing open-access materials through its digital platform and website, CT-Luso contributes directly to Open Science, transparency, and equitable knowledge transfer.
The early outcomes of CT-Luso demonstrate its potential to:
- Enable harmonised and efficient ethics and regulatory review processes;
- Strengthen scientific governance and the adoption of international standards (ICH-GCP);
- Enhance the attractiveness of PSACs for research investment and partnerships;
- Lay the foundation for a Lusophone Clinical Trials Cluster fostering sustainable African-European collaboration.