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

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Bringing antiretroviral drugs to children

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

The challenge

Effective regulatory systems and ethics review processes are essential to protect populations participating in clinical research, including clinical trials, and those receiving medical interventions. Their importance is reflected in their inclusion as one of WHO’s six building blocks of health systems – ensuring access to medical products of assured quality, safety and efficacy. 

In Senegal, key regulatory bodies include the National Council for Ethics and Health Research (CNERS) and the Department of Pharmacy and Medicine. While basic systems are in place, there is a need to constantly review and enhance procedures in light of developments in medicine and evolving ethical challenges. 

The SEN-ETHICS project aims to strengthen the capacity of Senegal’s national ethics committee and national regulatory authority to support better governance of clinical trials and other regulatory functions. A situational analysis has been undertaken in the areas of regulation and ethics, identifying gaps and development needs. A roadmap has been developed for the implementation of recommendations at the CNERS.

In the first year of the project, two regulatory workshops were organised, and during the course of the project 160 staff members will be trained on ethical and regulatory evaluation systems. Tools and procedures will be reviewed and updated as required, and also harmonised to improve collaboration across agencies.

The project has also begun work on the creation of a new institutional review board at IRESSEF, a recently launched national health and epidemiological research institute in Senegal.

To promote harmonisation and adherence to good practices, the project is being undertaken in collaboration with key regional bodies, including the African Vaccine Regulatory Forum, the Developing Countries Vaccine Regulators Network, and the African Medicines Regulatory Harmonisation Programme and its 11 Regional Centres for Regulatory Excellence. It is also coordinating activities with the EDCTP-funded BCA-WA-ETHICS project, which is working to mainstream gender perspectives into ethics review processes. 

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 SEN-ETHICS project will enhance the capacity, efficiency and coordination of regulatory and ethics review processes in Senegal, to ensure consistency with the highest international standards.

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