Africa accounts for 15% of the global population and 25% of the global disease burden – yet less than 2% of global clinical trials take place on the continent of Africa – those that do are mainly concentrated in 2 countries: South Africa and Egypt. As a result, during clinical drug development, most medicines are studied in clinical trials conducted outside Africa without considering implications of use in African patients or within African health systems.
The Coalition for African Research Initiative (CARI) is a nascent effort by the African Academy of Sciences (AAS) to build a highly coordinated, well-funded and African-led innovation enterprise for the African continent. In recognition of this the AAS was invited to present the Academy’s vision for building Research and Development (R&D) capacities in Africa at a convening of Global Leaders of Research Organizations in 2016. The group then proposed to facilitate more engagement between the private sector (particularly with the biopharma industry) and the AAS.
In recognition of CARI’s mandate and the conversation at that meeting, a subsequent panel discussion was organized at the World Economic Forum (WEF) in 2017 in Davos, this time engaging broader representation from global pharmaceutical companies to further discuss innovative and sustainable biomedical research in Africa. Senior leaders from the US National Institutes of Health (NIH) and Johnson & Johnson (J&J) played an important leadership role at this convening. The AAS engaged a consultancy firm to undertake a study to map the existing African clinical trial sites and their capabilities.
In October of 2018, as part of the Grand Challenges Annual Meeting (GCAM) in Berlin, Germany the AAS presented the pilot inventory mapping, and also heard from various other teams and organizations that are carrying out clinical trials/capacity building in Africa. A key outcome of the GCAM Berlin meeting was a recommendation that AAS, working with partners in Africa and globally, move forward to build a versatile, comprehensive open access database to provide real-time visibility of African clinical trials sites and their capabilities, to improve findability for potential collaborations across the product development ecosystem.
Vendor Identification: The AAS issued a well-advertised open Request for Information (RFI) call and later a Request for Proposals (RFP) call. Following a rigorous evaluation process of 15 high quality and high-profile applicants, Interactive Pharma Services (IPS), a digital technology service provider is currently being on-boarded and aligned towards the AAS’s vision for building the database utility. Acknowledging the social value of the project, some of the applicants who responded to the RFP expressed interest to collaborate towards the final solution – regardless of whether they were successful as the primary vendor.
This is a work in progress.
Stakeholder Engagement and Needs Assessment:
This has been and will continue to be a key activity as we seek to get buy in from key stakeholders, make sure that their needs are catered for and to complement rather than duplicate any other existing efforts. We have adopted an open approach of communication. Key stakeholders including biopharma representatives, product development partners (PDPs), local and international clinical researchers, and African regulatory representatives have been contacted via face-to-face (F2F) and/or teleconference (TC) meetings to comprehensively share the background to the project. Stakeholders have been encouraged to ask questions during our meetings and were also invited to send in any questions or concerns that might arise after the call.
The following areas have been identified as gaps that the database will seek to address:
Sites with experience in non-communicable diseases will be included since these remain poorly visible currently but are of great interest to the biopharmaceutical companies and for the continent’s growing dual epidemic.
Conversations between the vendor, the AAS and key stakeholders will continue throughout the database development process by having specific organized workshops and/or piggybacking on key scientific events where clinical sponsors and the investigator community meet. In addition, once the vendor is fully onboard, and a prototype has been developed, we plan to conduct multiple scientific and community engagement workshops across the continent.
In addition, we will hold a closed session meeting with representatives of the biopharmaceutical industry and funders at the Grand Challenges Annual meeting in Addis Ababa, Ethiopia 27th October, 2019.
Pharma, Product Development Partners and research sites: to share their own lists of site level intelligence with the AAS and its selected vendor.
Pharma companies to participate in clinical trial capacity building as we identify skills and infrastructure gaps.
Private-sector and public funders to partner with AAS to ensure the sustainability of the platform.
Ministry of Health/Regional regulators: to improve the efficiency of clinical trial application (CTA) processes e.g. via within country harmonization and parallel processing of IRB/EC and regulatory applications and cross-country mutual recognition of CTA’s where feasible
Support for expansion of the database to include other low- and middle-income countries beyond Africa or therapeutic areas of global health relevance.
Support to translate content of the database to other African Union recognized languages such as French, Portuguese and Arabic.
A steering committee comprising of reputable scientists involved with clinical research on the African continent has been set up to advise the AAS on all matters related to the project.
A communications plan has been defined. The target audience will include scientific communities on the continent, government officials and local communities where clinical trials are conducted, biopharma industry, PDPs and international funders. The goal is to create awareness of the project and to create a platform to get feedback from potential users. We expect that these efforts will translate to increased usage of the service, and ultimately to more high quality, ethical and relevant clinical trials across the continent.
Because this is an open access database with an initial defined funding period, we are actively seeking innovative self-sustaining funding models for the platform – including ideas on fair models for generating income that retains the goal of open-access.
The AAS acknowledges funding from the Bill & Melinda Gates Foundation to enable the initiation of this effort.
Meet the Team