Aiming to better understand the current situation, the AVAREF secretariat conducted the online survey in April 2020. All members states of the WHO African region were invited to participate in the online survey.
The findings on the joint review process were presented at the webinar by Dr Eun Mi Kim, WHO consultant on vaccine safety. Of the 29 countries that participated in the survey, 27 (93.1%) have received support from EDCTP to strengthen their national ethics and regulatory capacities.
Infographic: EDCTP2 investments in ethics and regulatory capacities
Seven countries (Niger, Burkina Faso, Comoros, Togo, Guinea Bissau, Zanzibar, Cote d’Ivoire) indicated that they do not have ethics review boards at universities or research institutes. The survey found that 51.2% of national regulatory authorities reviewed clinical trial protocols by paper review, 21.9% by electronic review and 26.8% by other methods.
Depending on the type of organisation – national regulatory authorities (NRAs), institutional review boards (IRBs) and national ethics committees (NECs) – 10-30% uses both paper and electronic submission procedures; 10% of these organisations developed their own online submission platform. Other digital platforms being used include online e-clinical trial application systems and integrated regulatory information management systems (iRIMS). Average fees charged per application varied from $2,836 (NRAs) to $1,287 (NECs) and $265 (IRBs).
AVAREF recognises that most African NRAs face serious resource constraints resulting in the lack of capacity for adequate review and approval of clinical trials. Aiming to strengthen clinical trial regulation in Africa, AVAREF views as next steps, among others, to establish internal standard processes, data management and enhancing data security for electronic review submissions.