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.

• Overwhelming confirmation of need
• Regulatory and Ethics approval process appears to be a major bottleneck
• Some concern from local trial sites that ranking processes will continue to favour use of the more established trial sites
• There are some priority disease areas including: Cancer and Sickle cell disease

The following areas have been identified as gaps that the database will seek to address:

• Up-to-date information on country specific clinical trial regulatory guidelines. Together with Africa Vaccine Regulatory Forum (AVAREF) which has been involved with regulatory strengthening activities since 2006, we developed a check list tool of this information, that was approved by the AVAREF steering committee in August 2019.  The tool has been presented to the member states and is currently being pilot-tested by 9 early adopter countries; Nigeria, Burkina Faso, Ghana, Cameroon, Gabon, Zimbabwe, Malawi, Kenya and Uganda.  Early experience and feedback on this tool will be presented to stakeholders at the GCAM in Addis Ababa, in October 2019.
• Up-to-date information on key clinical trial site capabilities and gaps will be critical for sponsors to target their more detailed subsequent trial-specific feasibility assessments.

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.

• Western Africa:– including Western and Northern regions. This will complement the initial awareness presentations already conducted in the Western region of Africa viz. Dakar, Senegal at the DELTAS Africa Annual meeting July 15th-17th and in Abuja, Nigeria at the 5th Annual meeting of the Global Emerging Pathogen Treatment consortium, August 7th-9th.
• Eastern Africa: including Central and Eastern regions at the Ifakara Health Institute in Tanzania.  1 -2 October, 2019
• Southern Africa: At an upcoming African Regulators meeting to be held in Victoria Falls, Zimbabwe, 2nd October, 2019.  At the AORTIC meeting which will target the Cancer clinical research community on the continent, Maputo, Mozambique 5th-8th November and at CAPRISA in Durban (dates are yet to be determined).

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.