Portuguese-Language Training Builds Clinical Trial Capacity in Lusophone Africa

A Portuguese-language training programme has graduated 234 professionals from Portuguese-speaking African countries in the ethical and legal requirements of clinical research, according to a descriptive evaluation published in BMC Medical Education. The initiative, known as CT-Luso, ran online from December 2024 to June 2025 and was designed to close a persistent gap: most international capacity-building efforts in research ethics and regulation are delivered in English or French, leaving Lusophone Africa largely excluded.

The CT-Luso project, scheduled to run from 2024 to 2027, builds on an earlier effort called the BERC-Luso Project, which operated from 2018 to 2022. Its first training level, titled “Ethical and Legal Requirements for the Development of Scientific and Clinical Research,” was coordinated jointly by Portuguese and African partners. The curriculum comprised 111 training hours, including evaluation, spread across six modules and targeted professionals working in regulatory authorities, ethics committees, research institutions and universities.

Interest in the programme was substantial. The organisers received 356 applications, of which 303 trainees enrolled and 234 ultimately graduated. The graduates had a mean age of 39 years and 53% were female, representing a range of academic and professional backgrounds concentrated in health and biomedical fields. Notably, 97% of graduates, or 226 of the 234, were employed in their home countries, suggesting the training reached people embedded in the national institutions that oversee research.

Academic outcomes were strong. The average final grade across the cohort was 80 out of 100, and 69% of graduates, 161 of 234, achieved a final grade of “Very Good” or “Excellent.” Assessment combined module-specific multiple-choice tests with recovery assignments and oral examinations. Successful completion of the course carried formal recognition of 12 European Credit Transfer and Accumulation System credits, aligning the training with an internationally understood academic standard.

The programme also collected continuous quality assurance data through surveys. Among the 70 respondents, 94%, or 66 participants, rated the programme “Very Good” or “Excellent,” and 91%, or 64 respondents, reported a high or very high perceived influence on their professional practice. A thematic analysis of open-ended responses highlighted three recurring themes: strengthened ethical and bioethical capacity, enhanced regulatory knowledge, and immediate application of the material in participants’ day-to-day professional contexts.

The authors are careful about the limits of the evidence. The evaluation focused on programme outputs and self-reported perceptions, and it lacked both a pre-training baseline and a control group. That means the reported satisfaction and perceived influence cannot be treated as measured changes in professional competence or in the performance of national regulatory systems. The findings describe what the programme delivered and how participants perceived it, not a demonstrated causal improvement in research oversight.

Even with those caveats, the results point to considerable unmet demand. The gap between 356 applications and 303 enrolled places, and the high completion rate among those admitted, suggest that Portuguese-speaking African countries contain a substantial pool of professionals seeking formal training in research ethics and trial regulation but rarely offered it in their working language. Language barriers, the authors argue, have historically excluded these countries from most international capacity-building initiatives.

The broader significance lies in the structure of the cohort. A diverse and relatively young group of graduates, concentrated in the health and biomedical sectors and working within their home countries, has the potential, in the authors’ framing, to foster long-term development by strengthening national research oversight and mentoring future professionals. Capacity in ethics committees and regulatory authorities is a recognised structural barrier to conducting biomedical research and clinical trials in these settings, and locally trained reviewers are one route to addressing it.

The authors position CT-Luso as a well-received model for closing capacity gaps in Portuguese-speaking African countries and as a framework that could be replicated in other low- and middle-income countries where language exclusion limits access to training. With the project running through 2027, the first training level represents an early stage of a longer effort, and the published evaluation provides a baseline of outputs and participant perceptions against which later levels of the programme can be compared.

Subject of Research: Portuguese-language capacity building for clinical trial ethics and regulation in Portuguese-speaking African countries

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

Article References: Batista, J. P. B., Patrão Neves, M., Sobrinho, C., & Ribeiro, M. A. (2026). Clinical trials in Lusophone Africa – results from a capacity building training initiative. BMC Medical Education. https://doi.org/10.1186/s12909-026-10626-8

Image Credits: AI Generated

DOI: 10.1186/s12909-026-10626-8

Keywords: clinical trials, research ethics, capacity building, Lusophone Africa, regulatory training, BMC Medical Education, Portuguese-speaking African countries, online education, ECTS credits, low- and middle-income countries, Clinical, trials