The European Union (EU) announced on Thursday 4 April the launch of the CT-Luso project, aimed at strengthening the training of specialists in ethics, regulation, biomedical research and clinical trials. In collaboration with the Ministry of Health (MISAU), the project aims to extend its influence to Portuguese-speaking African countries (PALOP).
“This initiative is the result of collaboration between the PALOP countries and is funded by the EDCTP3 Programme (Partnership between Europe and Developing Countries for the Conduct of Clinical Trials), with support from the EU, and will last 40 months,” explained Maria do Céu Patrão Neves, the project’s coordinator, during her presentation.
Without specifying the amount of funding, the coordinator explained that CT-Luso’s long-term ambition is to consolidate a Portuguese-speaking centre dedicated to clinical trials, thus strengthening research and development in this critical sphere for public health.
Tânia Sitoe, Chairman of ANARME’s Board of Directors, representing the Government, argued that Mozambican has several institutions already carrying out clinical trials, which demonstrates the country’s capacity to actively contribute to this project.
“Since 2007, the National Health Institute, through its statutory powers, has been conducting clinical studies on vaccines, therapeutics and diagnostics, totalling 28 trials to date.” Sitoe also said that “as a country, we are very well positioned for this project, as we have developed extensive experience. We are ready to share with everyone involved in this partnership and we also have a lot to learn from them. We recognise that there are procedures that we have not yet mastered and we believe that, through this project, we will have the opportunity to learn from our partners involved.”
ANARME emphasised the importance of cooperation between all the participants in the project, with the aim of improving ethical and regulatory procedures in clinical trials carried out in Mozambique.
CT-Luso brings together joint efforts from Angola, Cape Verde, Guinea-Bissau, Mozambique, São Tomé and Príncipe and Portugal, uniting experts in the fields of ethics, regulation, biomedical research and clinical trials, thus promoting a solid basis for scientific advances and ethical practices in the region.
The project is structured into different work packages, each led by different entities from the participating countries, and ranges from project coordination to legislative analysis, interdisciplinary education, advanced training, practical case studies, clinical trial simulations and communication and dissemination strategies. The Portuguese Order of Pharmacists is coordinating CT-Luso, with Mozambique’s National Bioethics Committee for Health assuming scientific responsibility.
This initiative represents a significant step towards strengthening clinical research capacities in the PALOP countries and promoting practices that meet international standards of ethics and regulation, with a view to significant improvements in public health and the development of critical competences in the biomedical field.