EDCTP portfolio: Clinical Research & Development Fellowships
index
The IGORCADIA project has strengthened the capacity of authorities in Liberia to regulate diagnostic use and oversee research on diagnostics.
Building capacity for diagnostics regulation in Liberia
Accurate diagnosis is vital in both clinical practice and research. Diagnostic use can guide choice of therapy in care settings, while accurate diagnosis is essential in research for determining the efficacy of treatments.
National regulatory authorities have responsibility for ensuring the safety and performance of diagnostics, and for overseeing research involving diagnostics. These functions require specific expertise in assessment of diagnostics. However, the health research system in Liberia has limited experience and capacity in diagnostic regulation and oversight of research involving diagnostics.
The challenge
The IGORCADIA project has successfully built the diagnostics-related capacity of the Liberian Medicines and Health Products Regulatory Authority (LMHRA). It focused on three key areas – LMHRA’s capacity to register and license the import and use of diagnostics, its ability to oversee and carry out diagnostics research, and coordination with other agencies.
Specific actions included a revision of Liberia’s diagnostics-related regulatory framework, in collaboration with the Liberian Ministry of Health and the National Research Ethics Board. Three LMHRA staff underwent extensive training at the Ghana Food and Drug Authority, a Regional Centre of Regulatory Excellence. International experts also undertook 15 days’ training on quality assurance for in vitro diagnostics.
LMHRA staff and those at project partner St Joseph’s Catholic Hospital in Monrovia also benefited from five three-day workshops on key topics in diagnostics research. Ten participants went on to participate in a research project on malaria diagnosis in the Hospital.
The project also strengthened links between the LMHRA and St Joseph’s Catholic Hospital, consolidating the latter’s position as a reference laboratory partner for the LMHRA. Education sessions were organised on new diagnostics technologies and hands-on refresher sessions on quality assurance and other aspects of Good Laboratory Practice and Good Clinical Practice. In addition, the Hospital’s General Director spent a week in Spain gaining high-level skills in health facilities and research units.
As well as enhanced networking between the LMHRA and St Joseph’s Catholic Hospital, the project also helped to establish a Diagnostic Steering Committee, through which the LMHRA shared progress with national and international stakeholders. In addition, links with the Liberian National Research Ethics Committee were strengthened, with the Committee coordinating training on ethical review and monitoring of diagnostics projects.
The project
The IGORCADIA project has built regulatory capacity in a specialist and highly dynamic area of health research, diagnostics. Strengthened regulatory capacity will create an environment more able to host research on these infections and ensure use of effective diagnostic products in clinical practice. Furthermore, new and strengthened networks will ensure the longer-term sustainability of the progress made during the project.
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
Accurate diagnosis is vital in both clinical practice and research. Diagnostic use can guide choice of therapy in care settings, while accurate diagnosis is essential in research for determining the efficacy of treatments.
National regulatory authorities have responsibility for ensuring the safety and performance of diagnostics, and for overseeing research involving diagnostics. These functions require specific expertise in assessment of diagnostics. However, the health research system in Liberia has limited experience and capacity in diagnostic regulation and oversight of research involving diagnostics.
The IGORCADIA project has successfully built the diagnostics-related capacity of the Liberian Medicines and Health Products Regulatory Authority (LMHRA). It focused on three key areas – LMHRA’s capacity to register and license the import and use of diagnostics, its ability to oversee and carry out diagnostics research, and coordination with other agencies.
Specific actions included a revision of Liberia’s diagnostics-related regulatory framework, in collaboration with the Liberian Ministry of Health and the National Research Ethics Board. Three LMHRA staff underwent extensive training at the Ghana Food and Drug Authority, a Regional Centre of Regulatory Excellence. International experts also undertook 15 days’ training on quality assurance for in vitro diagnostics.
LMHRA staff and those at project partner St Joseph’s Catholic Hospital in Monrovia also benefited from five three-day workshops on key topics in diagnostics research. Ten participants went on to participate in a research project on malaria diagnosis in the Hospital.
The project also strengthened links between the LMHRA and St Joseph’s Catholic Hospital, consolidating the latter’s position as a reference laboratory partner for the LMHRA. Education sessions were organised on new diagnostics technologies and hands-on refresher sessions on quality assurance and other aspects of Good Laboratory Practice and Good Clinical Practice. In addition, the Hospital’s General Director spent a week in Spain gaining high-level skills in health facilities and research units.
As well as enhanced networking between the LMHRA and St Joseph’s Catholic Hospital, the project also helped to establish a Diagnostic Steering Committee, through which the LMHRA shared progress with national and international stakeholders. In addition, links with the Liberian National Research Ethics Committee were strengthened, with the Committee coordinating training on ethical review and monitoring of diagnostics projects.
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 IGORCADIA project has built regulatory capacity in a specialist and highly dynamic area of health research, diagnostics. Strengthened regulatory capacity will create an environment more able to host research on these infections and ensure use of effective diagnostic products in clinical practice. Furthermore, new and strengthened networks will ensure the longer-term sustainability of the progress made during the project.
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