EDCTP portfolio: Clinical Research & Development Fellowships
index
The STREC-Ghana project is enhancing coordination across the bodies involved in clinical research oversight in Ghana.
Building regulatory and ethics review capacity in Ghana
Ghana has a relatively strong science base and a well-respected regulatory system for clinical research – it is, for example, a designated Regional Centre of Regulatory Excellence. Nevertheless, it faces increasing demands as the number of national and international clinical research proposals increases. In addition, it continues to face major infectious disease threats, including Ebola outbreaks.
The Council for Scientific and Industrial Research (CSIR-Ghana) is responsible for coordinating and regulating scientific research in Ghana. Its other key regulatory agency is Ghana’s Food and Drugs Authority (FDA), which has a mandate to coordinate, approve and certify all clinical trials.
The challenge
The STREC-Ghana project is improving coordination across Ghana’s regulatory bodies and its 17 accredited research ethics committees. It is also undertaking a systematic assessment of its regulatory, ethics and structural capacity, in order to identify key gaps and development needs.
The project is based on a partnership between CSIR-Ghana and the FDA, as well as with the Council on Health Research and Development (COHRED, headquartered in Switzerland), Pharmalys (Senegal) and Pharma Ethics (South Africa). This collaboration will enable a detailed review to be undertaken of capacity, based on a stakeholder participatory approach, to inform the development of plans to create a strengthened and more responsive system.
Based on this situational analysis, specialist and targeted technical training will be provided to those involved in the coordination, regulation and monitoring of clinical trials. The tried-and-tested RHInnO Ethics online ethics review system (https://rhinno.net) will also be introduced, with support of the project partners, to improve efficiency and the consistency of processes, and to enhance coordination across stakeholders.
The project
The STREC-Ghana project will ensure that Ghana maintains its commitment to continuing quality improvements in its regulatory systems, with more efficient processes and greater coordination across sectors. Ultimately, it will enable Ghana to maintain and enhance its favourable environment for high-quality clinical research.
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
Ghana has a relatively strong science base and a well-respected regulatory system for clinical research – it is, for example, a designated Regional Centre of Regulatory Excellence. Nevertheless, it faces increasing demands as the number of national and international clinical research proposals increases. In addition, it continues to face major infectious disease threats, including Ebola outbreaks.
The Council for Scientific and Industrial Research (CSIR-Ghana) is responsible for coordinating and regulating scientific research in Ghana. Its other key regulatory agency is Ghana’s Food and Drugs Authority (FDA), which has a mandate to coordinate, approve and certify all clinical trials.
The STREC-Ghana project is improving coordination across Ghana’s regulatory bodies and its 17 accredited research ethics committees. It is also undertaking a systematic assessment of its regulatory, ethics and structural capacity, in order to identify key gaps and development needs.
The project is based on a partnership between CSIR-Ghana and the FDA, as well as with the Council on Health Research and Development (COHRED, headquartered in Switzerland), Pharmalys (Senegal) and Pharma Ethics (South Africa). This collaboration will enable a detailed review to be undertaken of capacity, based on a stakeholder participatory approach, to inform the development of plans to create a strengthened and more responsive system.
Based on this situational analysis, specialist and targeted technical training will be provided to those involved in the coordination, regulation and monitoring of clinical trials. The tried-and-tested RHInnO Ethics online ethics review system (https://rhinno.net) will also be introduced, with support of the project partners, to improve efficiency and the consistency of processes, and to enhance coordination across stakeholders.
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 STREC-Ghana project will ensure that Ghana maintains its commitment to continuing quality improvements in its regulatory systems, with more efficient processes and greater coordination across sectors. Ultimately, it will enable Ghana to maintain and enhance its favourable environment for high-quality clinical research.
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