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

Abstract 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 (2018–2022), 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 is a descriptive evaluation of the first level of CT-Luso training “Ethical and Legal Requirements for the Development of Scientific and Clinical Research” , focusing on programme outputs and self-reported perceptions without a pre-training baseline or control group. 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%, n = 226/234) were employed in their home countries. Academic performance was very strong, with an average final grade of 80/100 and 69% of graduates ( n = 161/234) achieving a final grade of “Very Good” or “Excellent.” Quality assurance assessments reported high satisfaction, with 94% of respondents ( n = 66/70) rating the programme “Very Good” or “Excellent,” and 91% of responding participants ( n = 64/70) reporting high or very high perceived influence on their professional practice. Thematic analysis of open responses highlighted themes of strengthened ethical and bioethical capacity, enhanced regulatory knowledge, and immediate application in professional contexts. Conclusions The CT-Luso training programme achieved high enrolment and graduation outputs, yielding positive self-reported influences among respondents, thereby indicating unmet demand for Portuguese-language capacity-building in Africa. Its diverse and relatively young cohort of graduates has the potential to foster long-term development by strengthening national research oversight and mentoring future professionals. CT-Luso offers a well-received model for addressing capacity gaps in PSACs and provides a framework for replication in other Low- and Middle-Income Countries.