EDCTP portfolio: Clinical Research & Development Fellowships
index
The C2C-TEP project is enabling three countries spanning sub-Saharan Africa to learn from each other.
Sharing ethics learning across Africa
Independent ethical review of research proposals is an essential element of clinical research. Many countries in sub-Saharan Africa have made great strides in strengthening systems for ethical review of clinical research, yet challenges remain in embedding such systems within national regulatory frameworks.
With many countries facing similar challenges, there are opportunities for countries in sub-Saharan Africa to share experiences and learn from each other, as well as from countries with longer-established ethical review systems.
The challenge
The C2C-TEP project is a South–South collaboration supported by internationally recognised ethics review experts. It links together stakeholders from East and West Africa, specifically Ethiopia, The Gambia and Ghana.
The project is founded on an evaluation of the current strengths and weaknesses of the existing research ethics review systems in the three countries. It has also explored how well national and institutional research ethics committees engage with national regulatory authorities.
These findings have been presented to representatives of stakeholder organisations, such as national ethics committees and research ethics committees/institutional review boards. These analyses will be used to develop strategies and action plans for improving national and institutional review systems.
The consortium aims to monitor implementation of improvement plans, and produce practical guidance that can be used to inform planning in other countries in the region.
The project
The C2C-TEP project will enable the three countries involved to share experiences and learn from one another, avoiding duplication of efforts and promoting coordinated approaches to ethical review. As well as strengthening ethical review systems in individual countries, the project should also promote cross-country harmonisation, facilitating multicentre studies spanning the different countries.
Impact
“
test the safety and efficacy of this new formulation in young children
”
Bringing antiretroviral drugs to children
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
Independent ethical review of research proposals is an essential element of clinical research. Many countries in sub-Saharan Africa have made great strides in strengthening systems for ethical review of clinical research, yet challenges remain in embedding such systems within national regulatory frameworks.
With many countries facing similar challenges, there are opportunities for countries in sub-Saharan Africa to share experiences and learn from each other, as well as from countries with longer-established ethical review systems.
The C2C-TEP project is a South–South collaboration supported by internationally recognised ethics review experts. It links together stakeholders from East and West Africa, specifically Ethiopia, The Gambia and Ghana.
The project is founded on an evaluation of the current strengths and weaknesses of the existing research ethics review systems in the three countries. It has also explored how well national and institutional research ethics committees engage with national regulatory authorities.
These findings have been presented to representatives of stakeholder organisations, such as national ethics committees and research ethics committees/institutional review boards. These analyses will be used to develop strategies and action plans for improving national and institutional review systems.
The consortium aims to monitor implementation of improvement plans, and produce practical guidance that can be used to inform planning in other countries in the region.
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 C2C-TEP project will enable the three countries involved to share experiences and learn from one another, avoiding duplication of efforts and promoting coordinated approaches to ethical review. As well as strengthening ethical review systems in individual countries, the project should also promote cross-country harmonisation, facilitating multicentre studies spanning the different countries.
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