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EDCTP portfolio: Clinical Research & Development Fellowships

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The BERC-Luso project is building ethical review and clinical research regulatory capacity in five Portuguese-speaking countries – Angola, Cape Verde, Guinea Bissau, Mozambique and São Tomé and Príncipe.

Regulatory and ethics capacity-building in Portuguese-speaking countries

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Strong national regulatory and ethics review frameworks for clinical research are essential to protect the interests of research participants and to create a conducive environment for clinical trials. However, many resources to support development of national regulatory and ethics review capacity are in English, disadvantaging Portuguese-speaking countries in the region.

Conversely, there are opportunities for countries to collaborate and coordinate development of regulatory and ethics review frameworks, avoiding duplication of efforts and promoting sharing of experiences across countries.

The challenge

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The BERC-Luso project aims to develop and strengthen national medicines regulatory systems and ethical review of clinical research in five Portuguese-speaking countries – Angola, Cape Verde, Guinea Bissau, Mozambique, and São Tomé and Príncipe. As well as networking between these countries, it is also drawing on the expertise of Portuguese institutions with well-established regulatory systems.

The project is engaging with national ethics committees and national regulatory agencies. One key action has been a comparative analysis of the legislative framework for clinical research and regulatory bodies in the five participating countries. These comparisons, and benchmarking against international standards, were fine-tuned at a specially convened workshop in Lisbon, and have been used to create roadmaps for the development of national legislative frameworks in the participating African countries. The workshop was held immediately before a symposium organised by the project on international best practices in clinical research and the project’s work with Portuguese-speaking countries in sub-Saharan Africa.

The project will also be working to develop the skills and expertise of members of national ethics committees and national regulatory agencies, through an intensive theoretical and practical education programme and training, including internships in Portuguese institutions to apply knowledge.

The project has created a Portuguese-language website to strengthen networking between sites. This includes a digital repository of documents in Portuguese to support national ethics committees and national regulatory agencies activities.

The project

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The BERC-Luso project is strengthening links between Portuguese-speaking countries, and between these countries and Portugal, accelerating the development of regulatory environments that protect populations and facilitate clinical research for the benefit of local people.

Impact

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test the safety and efficacy of this new formulation in young children

Bringing antiretroviral drugs to children

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The CHAPAS trials have ensured that many more children with HIV have benefited
from life-saving antiretrovirals.

EDCTP portfolio: HIV & HIV-associated infections

The challenge

Strong national regulatory and ethics review frameworks for clinical research are essential to protect the interests of research participants and to create a conducive environment for clinical trials. However, many resources to support development of national regulatory and ethics review capacity are in English, disadvantaging Portuguese-speaking countries in the region.

Conversely, there are opportunities for countries to collaborate and coordinate development of regulatory and ethics review frameworks, avoiding duplication of efforts and promoting sharing of experiences across countries.

watermark

The BERC-Luso project aims to develop and strengthen national medicines regulatory systems and ethical review of clinical research in five Portuguese-speaking countries – Angola, Cape Verde, Guinea Bissau, Mozambique, and São Tomé and Príncipe. As well as networking between these countries, it is also drawing on the expertise of Portuguese institutions with well-established regulatory systems.

The project is engaging with national ethics committees and national regulatory agencies. One key action has been a comparative analysis of the legislative framework for clinical research and regulatory bodies in the five participating countries. These comparisons, and benchmarking against international standards, were fine-tuned at a specially convened workshop in Lisbon, and have been used to create roadmaps for the development of national legislative frameworks in the participating African countries. The workshop was held immediately before a symposium organised by the project on international best practices in clinical research and the project’s work with Portuguese-speaking countries in sub-Saharan Africa.

The project will also be working to develop the skills and expertise of members of national ethics committees and national regulatory agencies, through an intensive theoretical and practical education programme and training, including internships in Portuguese institutions to apply knowledge.

The project has created a Portuguese-language website to strengthen networking between sites. This includes a digital repository of documents in Portuguese to support national ethics committees and national regulatory agencies activities.

The project

The later CHAPAS-3 trial compared the efficacy and safety of three fixed-dose combinations including two without stavudine (found to have some long-term side effects in adults, leading to a recommendation that its use be discontinued in children). The trial the first of its kind in Africa studied nearly 500 children at four sites in two African countries.

The BERC-Luso project is strengthening links between Portuguese-speaking countries, and between these countries and Portugal, accelerating the development of regulatory environments that protect populations and facilitate clinical research for the benefit of local people.

ratios forfixed-dose combinations and on appropriatedosage according to weight. 

The CHAPAS-3 trial confirmed the effectiveness of fixed-dose combinations, providing further impetus to the rollout of antiretrovirals to children. Its evidence on abacavir informed the WHO recommendation of abacavir-containing combinations for first-line therapy in children. Trial data have also been used to support applications for regulatory approval for new scored efavirenz tablets.

Impact

L’homme RF et al. Nevirapine, stavudine and lamivudine pharmacokinetics in African children on paediatric fixed-dose combination tablets. AIDS. 2008;22(5):557–65.

Mulenga V et al. Abacavir, zidovudine, or stavudine as paediatric tablets for African HIVinfected children (CHAPAS-3): an open-label, parallel-group, randomised controlled trial. Lancet Infect Dis. 2016;16(2):169–79.

WHO. Guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. 2010.

WHO. Consolidated guidelines on the use of antiretroviral drugs
for treating and preventing

HIV infection: Recommendations for a public health approach
(second edition). 2016

Projects: Children with HIV in Africa Pharmacokinetics and Adherence of Simple Antiretroviral Regimens (CHAPAS): CHAPAS-1 and -3

Project lead: Professor Chifumbe Chintu, University Teaching Hospital, Zambia (CHAPAS-1); Dr Veronica Mulenga, University Teaching Hospital, Zambia (CHAPAS-3)

Target population(s): Children with HIV

Sample size: 71 (CHAPAS-1); 480 (CHAPAS-3)

Countries involved: Ireland, the Netherlands, the UK, the USA, Zambia (CHAPAS-1); Uganda, Zambia (CHAPAS-3)

Project duration: 2005–2009 (CHAPAS-1); 2010 –2011 (CHAPAS-3)

EDCTP funding: €1.2M (CHAPAS-1); €4.6M (CHAPAS-3)

Total project funding: €1.2M (CHAPAS-1); €5.0M