WHO AVAREF survey highlights EDCTP’s role in supporting ethical and regulatory oversight in Africa

09 June 2020

In April 2020, the African Vaccine Regulatory Forum (AVAREF) conducted a digital survey of the state of regulatory activities and ethical review in Africa. On 21 May 2020, the results were presented at a webinar organised by WHO AFRO through the AVAREF Secretariat, which was attended by approximately 125 partners of AVAREF including EDCTP. The survey focused on AVAREF’s joint review process. The results highlight EDCTP’s role in strengthening the capacity for ethics review in African countries, including the use of online platforms.

Survey results

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. 

The AVAREF joint review process

In the webinar, Dr Diadié Maïga (WHO/AFRO), Technical Officer (Vaccine Regulation) described the AVAREF process for joint scientific and ethics review of clinical trial applications

The WHO Regional Office for Africa has a mandate to facilitate joint review of clinical trials in African countries. National regulatory authorities and national ethics committees have agreed to use the AVAREF platform. At the request of sponsors, the AVAREF secretariat facilitates joint reviews, which currently should take no more than 60 working days.

Joint reviews bring important advantages such as better protection of human subjects, scientific and ethical robustness, more expeditious ethics review, and the sharing of knowledge and experience among regulators and ethics committees. Efficiency gains are potentially diminished by lengthy post-authorisation steps required for trial commencement.

AVAREF encourages countries to coordinate and streamline these steps to allow for timely commencement of trials. Cooperation among participating NRAs and NECs is expected to extend beyond the approval of the clinical trial. Ultimately, the objective is for all 55 African Member States to adopt the standardised tools for the evaluation of clinical trial applications, including those regarding emergency preparedness. 

Partnership of AVAREF and EDCTP

The African Vaccine Regulatory Forum (AVAREF) brings together National Regulatory Authorities (NRAs)  and National Ethics Committees (NECs) with the objective of strengthening clinical trial regulation in Africa. Established by the World Health Organization in 2006, AVAREF has since then evolved into a strong network of partners and medical professionals whose focus is to build capacity and improve the harmonisation of practices in support of product development.

EDCTP contributed to the formation of AVAREF through two grants to the WHO global training programme for regulators. The grants resulted in training 15 Francophone and 15 Anglophone regulators who conceptualised the role of AVAREF. Moreover, EDCTP2 grants have been instrumental in the continued strengthening of capacities of sub-Saharan Africa regulators, including in projects which involved collaboration with national ethics committees.

Dr Thomas Nyirenda, EDCTP Strategic Partnerships and Capacity Development Manager, is a member of the AVAREF Technical Coordination Committee and Steering Committee. AVAREF is also one of the six working groups under the African Medicines Regulatory Harmonisation (AMRH) platform of which EDCTP is also a member.