Clinical trials in Lusophone Africa – results from a capacity building training initiative

Background: Portuguese-speaking African countries (PSACs) face structural barriers in conducting biomedical research and clinical trials, including limited ethical and regulatory capacity-building opportunities. Most international capacity-building initiatives are conducted in either English or French, thus often excluding PSACs due to language barriers. The CT-Luso project (2024-2027), building on the BERC-Luso Project, was designed to address this gap, through providing comprehensive training in Portuguese on the ethical and regulatory requirements of clinical trials in Africa. Methods: this study evaluated the first level of CT-Luso training “Ethical and Legal Requirements for the Development of Scientific and Clinical Research” . The programme, coordinated jointly by Portuguese and African partners, ran online from December 2024 to June 2025, and comprised 111 training hours (including evaluation) across 6 modules. It targeted a broad range of professionals in regulatory authorities, ethics committees, research institutions, and universities. Evaluation included module-specific multiple-choice tests, recovery assignments, and oral assessments, complemented by continuous quality assurance surveys. Successful completion granted 12 European Credit Transfer and Accumulation System (ECTS) credits. Results: A total of 356 applications were received, of which 303 trainees enrolled and 234 graduated. Graduates (mean age 39 years; 53% female) represented diverse academic and professional backgrounds, predominantly in health and biomedical areas. Nearly all graduates (97%) were employed in their home countries. Academic performance was very strong, with an average final grade of 80/100 and 69% of graduates rating “Very Good” or “Excellent.” Quality assurance assessments reported high satisfaction, with 94% rating the programme “Very Good” or “Excellent,” and 91% reporting high or very high professional impact. Thematic analysis of open responses highlighted strengthened ethical and bioethical capacity (30%), enhanced regulatory knowledge (11%), and immediate application in professional contexts. Conclusions: The CT-Luso training programme exceeded expectations in enrolment, graduation, and impact, confirming unmet demand for Portuguese-language capacity-building in Africa. Its diverse and relatively young cohort of graduates is positioned to foster long-term development by strengthening national research oversight and mentoring future professionals. CT-Luso demonstrates a successful model for addressing capacity gaps in PSACs and offers a framework for replication in other low- and middle-income countries. Clinical trial number: not applicable