Only 2% of the clinical trials conducted globally occur on the African continent. There are many factors contributing to this low investment, but we would like to highlight 2 topics relevant to this update report: the dearth of knowledge on the location and capabilities of existing clinical trial sites, and the uncertainties associated with competency, expectations, and timelines of regulatory and ethical reviews across the 55 African countries. For these reasons, the process of site feasibility analysis can be onerous for the trial sites and time-consuming and expensive for the trial sponsors.
The African Academy of Sciences led an effort to identify gaps, elicit stakeholder interest via a pilot project, and eventually obtained funding to develop an open-access platform that will bring together key players in the clinical trials space to; increase their visibility, provide site feasibility intelligence important in decision making and encourage continuous engagement among stakeholders. Our initial pool of stakeholders include: local and international clinical researchers, biopharma representatives, product development partners, African regulatory representatives and clinical trial participants.
To this end, a series of stakeholder engagement meetings were held in 2019 to gather user requirements that will shape key elements of the platform. Using this data, the AAS will work with experts in software development and seek input from an advisory committee to prioritize identified elements and pave the way for the actual development of the system. This will be followed by a series of meetings with representatives from the various stakeholder groups. These meetings will allow participants to provide real-time feedback on the platform’s functionality thus informing future iterations to meet user needs.
Database Developer: In 2019, The African Academy of Sciences began the implementation of the first phase of the Clinical Trials Community (CTC) by of gathering in-depth user requirements and other preliminary work necessary to inform the development of a centralised, open-access platform of clinical research sites and capabilities on the African continent. . The user requirements have been collated and the AAS team has spent considerable time synthesising all the user requirement data obtained thus far and will prioritise features that will go onto the platform in consultation with the CTC advisory committee. The next phase will be to build a beta version of the platform also referred to as the minimum viable product (MVP)
Stakeholder Engagement and Needs Assessment
The Academy hosted seven consultative workshops for scientists, international clinical researchers, biopharma representatives, product development partners (PDPs), and African regulatory representatives across the continent to gather the user requirements. Stakeholder engagement has also been key to get buy-in and to establish the structure and format of this collaborative platform.
The meetings were conducted across the continent as shown in the below:
An advisory committee comprising reputable experts in the clinical trials space on the African continent has been set up to advise the AAS:
Meet the Team