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INDEPTH Effectiveness and Safety Studies of Anti-malarial Drugs in Africa (INESS)
This was a platform that aimed at enabling African researchers to carry out large Phase IV trials. This is a US$28,615,239 project funded by the Bill & Melinda Gates Foundation.
The key objectives were:
- To develop and maintain Phase IV – Effectiveness studies of Anti-malarials in Africa
- To assess the effectiveness of new malaria treatments and its determinants in real life
- To evaluate the safety of new treatments through a comprehensive pharmacovigilance in a health systems context
Working through task teams from three regional and international collaborative sub-partners: the School of Public Health, University of Ghana, the Swiss Tropical and Public Health Institute (SwissTPH) and the US Centers for Disease Control (CDC) , there was development, training and field testing of tools and Standard Operating Procedures (SOPs) for the different modules prior to adaptation and use.
The study was implemented in 7 HDSS sites: are Dodowa, Kintampo and Navrongo (Ghana), Rufiji (Tanzania), Nanoro and Nouna (Burkina Faso), and Manhica (Mozambique). The grant period ended in March, 2015.
Phase IV study for the newly registered antimalaria, Dihydroartemisinin Piperaquine (with the generic, Eurartesim) of the INESS study
The drug, Eurartesim was approved by European Medical Agency (EMA) for registration in October, 2011. Few conditions were attached to the registration including data on a phase IV study by the INDEPTH Network using the INESS platform as part of the risk management plan. Series of meetings were held between INESS partners, Sigma Tau and MMV in preparation for the phase IV study in 4 countries (Ghana, Burkina Faso, Tanzania and Mozambique) on the INESS platform before and after registration of the product with EMA.
