INNOVATIVE MODEL FOR STRATEGIC MANAGEMENT OF QUALITY AT RESEARCH SITES IN AFRICA (16-18 Aug 2019)
The African Clinical Trials Consortium (ACTC) was established in 2018 with the aim of bringing together research active sites and investigators to share good practice and develop strategic direction for the management of trials in Africa. The intention of the 2019 conference is to propose a system for the development, training and establishment of ‘accredited’ units in each of the countries. The ACTC will be the management/coordinating centre for these activities. Building confidence in industry and funding agents is critical to the growth of trials in Africa. Furthermore, commitment to the proposed model at Departments of Health and Industry leaders is essential.
Clinical Trial Units (CTUs) were established in High Income Countries (HICs) to standardise practice according to GCP. Now most trials are required to be supported by a CTU. This was not an easy transition but it instilled confidence in industry and funding agents alike. This is the leap of faith African countries need to take. We need to instil confidence quickly, efficiently, with minimal cost and sustainability for the future.
We are proposing that the ACTC becomes the gateway and coordinating centre to trials in Africa. All industry trials are fed through this coordinating centre which then distributes feasibility notifications to countries who have sites/CTUs that have met a minimum requirement (staff, training, facilities etc) and are thus a consortium partner.
Consortium members will:
Share all standard operating procedures (SOPs), templates for clinical trial agreements (CTAs) or material transfer agreements (MTAs)
Benefit from budget development for sites, not for industry.
Have access to cross country training/mentoring
Access to reciprocal auditing of the sites
Access to advise and guidance with respect to medical/health regulatory authorities (MHRAs) and ethics committee submissions
Access to online training
Database sharing opportunities
Database of trials in Africa – we will use EDGE programme to collect data from all sites as part of the coordinating centre's role.
Confidence in industry is achieved by demonstrating a commitment, no matter how hard, to upholding standards with a bottom-line expectation to become part of the consortium. Those countries with barriers to becoming a consortium partner MUST be supported by other countries to try to overcome them. This will be a requirement of membership. Each country will assign people responsible for updating the coordinating centres list of potential investigators and their therapeutic areas for sending out feasibility requests.
In Africa all research centres/sites need to be self-sustaining. This means they must think and run like a business. This is a strategic imperative for success. The summit will include sessions from the University of Cape Town (UCT), Graduate School of Business on fiscal and operational sustainability. Training will be provided centrally for each site/unit representative and site visits will follow by business advisors from the Graduate School of Business.