Advancing inclusive research (AIR) in Africa: Strengthening healthcare systems to enhance access on the continent through the Africa AIR site alliance model.
Authors: Ntekim Atara Isaiah , Belbaraka Rhizlane , Moyaba Tumelo , Ochieng Primus , Bulhan Huwaida , Akindigh Terver , Ramuthaga Nathaniel , Nelmawondo Matodzi , Ibn El Haj Hanae , Ofori-Atta Catherine , Kiraba Angela , Johnstone Micheal , Richie Nicole , Bhagat Ruma 
Published: May 2024

e13778 Background: While Africa makes up 17% of the total world population, it has 24% of the global disease burden. Furthermore, although Africa is rich in genomic diversity, Africans make up <4% of the patients in global pharma studies and 1% of the global genomic database. In 2020 there were only 63 African patients in Roche global clinical trials. The Africa AIR Site Alliance model was undertaken to address the growing importance of interventional clinical trials with advanced diagnostics and therapies in Africa, as well as the lack of representation of the African population in global datasets, which contribute to continued health disparities, poor outcomes and existing inequities. Methods: In countries with a legal research framework, no clinical trial holds and who have conducted at least 1 Roche clinical trial during the last 5 years potential Centers of Excellence for the Africa AIR Site Alliance were identified. For patients, sites had invoiceable services to ensure they were supported and could potentially include education about clinical trial participation, reasonable travel and accommodation, or covering the cost of missed work or childcare. Sites participated in training on how to conduct clinical trials, including opportunities to share best practices across sites. Results: Four pilot countries were selected and had Centers of Excellence identified to work as partners with Roche for global clinical trials: Morocco (Marrakech University Hospital Center), Nigeria (University College Hospital Ibadan), Kenya (University of Nairobi Institute of Tropical and Infectious Diseases) and South Africa (Limpopo Cancer Research Institute). After entering the Africa AIR Site Alliance, sites reported consistent application of standard operating procedures and manuals, trained and empowered staff, increased organization and appropriate patient support, plus knowledge and experience with industry trials. Sites are successfully participating in an increased number of global clinical trials in various therapeutic areas with 23 patients enrolled at the Africa AIR Site Alliance sites in oncology and ophthalmology studies. Conclusions: The Africa AIR Site Alliance model is a groundbreaking initiative that has the potential to revolutionize clinical research in Africa with a positive long-term impact on the African healthcare ecosystem and clinical care delivery. Limited diversity and representation in genomic, safety and efficacy data have hampered scientific and medical progress on the continent. The Africa AIR Site Alliance provides critical support, knowledge and skills for conducting clinical trials and assists in removing barriers for underrepresented patients to participate in these trials. Future work will focus on expanding to additional countries in Africa and creating a robust network of Centers of Excellence for innovative research.