Project: A European-African network for strengthening the regulatory capacity for clinical research and pharmacovigilance in Central Africa: implementation of harmonized procedures, efficient guidelines and training programs

Acronym AFRICLINIQUE (Reference Number: CSA2018ERC-2319)
Duration 01/10/2019 - 30/09/2024
Project Topic Despite being home to >16% of the world’s population, Africa currently only hosts 2,7% of the clinical studies. In African countries, clinical research contributes to major public health needs, such as access to improved healthcare infrastructure and access to treatments. However, the number of clinical trials in Central African countries, such as Cameroon and Republic of the Congo (RoC) is lagging, compared to other African regions. This is caused mainly by the absence of proper regulatory infrastructure to ensure efficient evaluation and oversight of clinical trials, and the absence of an adequate pharmacovigilance system. Due to this lack of an adequate regulatory framework, clinical research organisations resort to other African countries for clinical trials. Thus, there is a huge need for increased regulatory capacity in Central African countries. Several initiatives aim to improve the capacity for clinical trials in Africa. AVAREF aims to improve the regulatory and ethical guidelines throughout Africa. It has achieved a strong impact in various African countries, but the situation in the Central African region remains critical. CANTAM is an EDCTP-funded initiative hosted by FCRM aiming to improve the research and medical capacity for diagnosis and treatment of priority diseases in Central Africa. However, despite having realised increased medical and research capacity, initiation of clinical trials is hampered by the lack of regulatory capacity in Central Africa. The goal of the Africlinique project is to increase the capacity of national regulatory authorities (NRAs) in Cameroon and RoC, thereby attracting clinical studies to the Central African region. To achieve this goal, a sustainable collaborative network will be established connecting Central African NRAs, European NRAs and NRA-supporting initiatives (AVAREF and CANTAM). Collectively, the network will develop an implementation plan for NRAs to implement efficient SOPs, harmonised guidelines, training programmes and pharmacovigilance protocols. Moreover, sustainable communication and education channels are established and a joint advocacy campaign will raise awareness among clinical research organisations regarding the economical and societal benefits of clinical trials in Central Africa, drawing clinical trials towards the region. NRAs of other Central African countries (e.g. Gabon) will join the network and implement the improved harmonised regulatory framework at a later stage. Results of the project will be disseminated to stakeholders, including public and private clinical research organisations. By improving the regulatory capacity of Central African NRAs and by collective efforts of the sustainable Africlinique network, this project will have a lasting footprint on the clinical research climate in Central Africa.
Network EDCTP2
Call Ethics and regulatory capacities 2018

Project partner

Number Name Role Country
1 Fondation Congolaise pour la Recherche Médicale Coordinator Congo, Democratic Republic of the
2 Ministry of Health and Population of the Republic of Congo Partner Congo
3 Ministry of Public Health - Cameroon Partner Cameroon
4 R-Evolution Worldwide Community Interest Company Partner United Kingdom