AVAREF, Advancing Clinical Trials Excellence, is a network (platform) for all member states in Africa dedicated to capacity building and strengthening for clinical trials. It was established in 2006 by WHO with an initial focus on National Regulatory Authorities (NRAs) and National Ethics Committees (NECs).

WHO acts as a facilitator, coordinator, and supporter of the AVAREF network. The AVAREF Secretariat is hosted by the WHO Regional Office for Africa, where staff ensure the implementation of workplans approved by member states. WHO-AFRO also mobilizes funding for AVAREF’s continued operations of the network.

AVAREF is governed by an Advisory Committee (made of heads of NRAs and NECs) and a Technical Coordinating Committee (made up of technical experts) nominated by member states to ensure regional and linguistic representation. The daily operations are coordinated and implemented by the AVAREF Secretariat.

AVAREF’s Programs and Activities are supported by WHO and an increasing number of donors and partners including CEPI, Wellcome Trust, Gates Foundation, regulatory agencies such as PEI, and EDCTP.

AVAREF serves as the Technical Coordinating Committee for AMA and is responsible for clinical trial oversight within AMA. AVAREF supports the establishment and operationalization of AMA’s clinical trial unit. Future roles and responsibilities will be defined by a mutual agreement between WHO and AMA.

All 55 African member states are part of AVAREF. Approximately 40 countries actively participate in activities such as multi-country joint reviews for clinical trial applications.

AVAREF offers a range of services including workforce development, strengthening of regulatory and ethics systems, provision of technical support, support for emergency preparedness, strengthening ecosystems across the innovation life cycle, and facilitating collaboration among member states.

AVAREF contributes to regulatory and ethics harmonization by:

• Development of Norms & Standards – Guidance Documents, Guidelines, Templates, and Checklists for clinical trial authorization.
• Development of common digital platforms for worksharing including participating in multi-country joint reviews and scientific advice.
• Offering continuing education, including simulations, for comprehensive and specialized training for the review of clinical trial applications.
• Preparedness for emergencies such as epidemics and pandemics through a combination of a wide range of activities described above.

AVAREF supports member countries with clinical trial ecosystem optimization exercises which provides recommendations on how to streamline their processes for NRAs, NECs, and other stakeholders to support timely and high quality decisions.

• Regulatory and ethics capacity building for clinical trials in member countries.
• A platform for multi-country joint reviews and scientific advice for clinical trial applications, and the registration of medicines during emergencies such as Mpox, Ebola, and COVID-19.
• AVAREF has played a critical role in accelerating research and development through its platform, supporting clinical trials for vaccines targeting meningococcal meningitis, rotavirus diarrhea, Hemophilus influenzae type b (Hib), pneumococcal pneumonia, cholera, RTS,S (malaria), tuberculosis and HIV, meningococcal A conjugate, Ebola and COVID-19. meningitis (Neisseria meningitidis and Streptococcus pneumoniae), TB, cholera, and cervical cancer, HIV
• More recently, AVAREF platform supported trials for neglected tropical diseases such as Lassa Fever and Rift Valley Fever as well as complex designs including adaptive designs for severe malaria, snakebite, and controlled human infection models (CHIM).

WHO-AFRO-AVAREF Secretariat continues supporting member states alongside AMA with a renewed focus on underserved aspects of the ecosystem for clinical trials and vaccine manufacturing.

AVAREF Secretariat, Technical Committee for Clinical Trials for AMA will continue to use its ecosystem and life cycle approach to support Africa attaining 10% of global clinical trial activity by 2035.

AVAREF will leverage its network of NRAs, presence in member states, partnerships, and alliances to strengthen health sovereignty for member states through increased access to medicines, vaccines, and health products that are safe, effective, affordable and of assured quality.

AVAREF Secretariat will support AVAREF/Member states in capacity strengthening through trusted expertise, partnerships for results, and life cycle approach.

AVAREF expects complete operationalization of AMA Clin Trial Unit in due time and will continue strengthening and developing the Networks namely, National Ethics Committees, Clinical Researchers/Centers Network, Vaccine Manufacturing Network, and Effectiveness (MoVE) Network.

AVAREF will continue to provide Technical Support for Member States, Advocacy and leadership, Trusted Support and Expertise, and Enhanced partnerships and alliances.