EDCTP portfolio: Clinical Research & Development Fellowships
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The SteRN project is promoting interactions between research oversight bodies and the research community to strengthen governance mechanisms for clinical research in Ethiopia.
Building regulatory and ethics review capacity in Ethiopia
Over recent decades, Ethiopia has made great strides in addressing its health challenges, for example achieving substantial reductions in neonatal and maternal mortality. Its Health Sector Transformation Plan has set ambitious targets for the future. The Plan includes a commitment to research and evidence-based decision-making.
However, although countries such as Ethiopia often have a coherent policy framework for regulation of health research, implementation of policies is often incomplete.
The challenge
The SteRN project aims to build capacity to accelerate the implementation of policy and processes for the effective oversight of clinical research in Ethiopia. The project will be coordinated by the National Ethical Review Committee, in partnership with the national regulatory authority and research institutions in Ethiopia and other African countries.
The project’s activities will be based on a review of clinical trials activity in Ethiopia and a needs assessment to determine development priorities for clinical trials ethics review. A training programme will be established to develop institutional capacity in ethical review, including master’s-level education and continuing professional development. An online platform will be introduced to improve the efficiency of research protocol review. The project will also facilitate accreditation by WHO and strengthen monitoring and evaluation.
The project also aims to strengthen networking and coordination of stakeholders with an interest in ethical review of clinical research in Ethiopia.
The project
The SteRN project will make a significant contribution to the development of an enabling environment for clinical research in Ethiopia, facilitating the studies that will be needed for it to achieve its ambitious public health goals.
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
Over recent decades, Ethiopia has made great strides in addressing its health challenges, for example achieving substantial reductions in neonatal and maternal mortality. Its Health Sector Transformation Plan has set ambitious targets for the future. The Plan includes a commitment to research and evidence-based decision-making.
However, although countries such as Ethiopia often have a coherent policy framework for regulation of health research, implementation of policies is often incomplete.
The SteRN project aims to build capacity to accelerate the implementation of policy and processes for the effective oversight of clinical research in Ethiopia. The project will be coordinated by the National Ethical Review Committee, in partnership with the national regulatory authority and research institutions in Ethiopia and other African countries.
The project’s activities will be based on a review of clinical trials activity in Ethiopia and a needs assessment to determine development priorities for clinical trials ethics review. A training programme will be established to develop institutional capacity in ethical review, including master’s-level education and continuing professional development. An online platform will be introduced to improve the efficiency of research protocol review. The project will also facilitate accreditation by WHO and strengthen monitoring and evaluation.
The project also aims to strengthen networking and coordination of stakeholders with an interest in ethical review of clinical research in Ethiopia.
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 SteRN project will make a significant contribution to the development of an enabling environment for clinical research in Ethiopia, facilitating the studies that will be needed for it to achieve its ambitious public health goals.
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