Partnerships and Collaborations: The Right Alliances for Clinical Trials in Africa

Abstract

<jats:p> Africa attracts &lt; 1% of all trials conducted around the world. The implication is that proof of safety and efficacy in Africans is lacking for a lot of new therapies. The sizeable proportion of approximately 20% of the global population that Africa represents largely does not have empiric data to support use of new therapies in a population with a distinct genetic and racial profile. Beyond the imperative of evidence-based interventions, Africans carry a disproportionately heavy burden of certain diseases, including prostate cancer, sickle cell anemia, and malaria. It therefore provides opportunity for efficient recruitment of participants for trials for such diseases. However, this advantage has not convinced sponsors to carry out clinical trials in Africa. India and China each have roughly the same population size as Africa, but each presents just one regulatory jurisdiction for clinical trials. Africa has 54 countries, and a sponsor would theoretically need to file 54 different applications to cover the entire continent. Collaboration and partnership among all stakeholders in the clinical trial ecosystem will reduce the burden on sponsors and make Africa competitive as a destination for clinical trials. Collaboration among national regulatory agencies will enable Africa to be treated as one regulatory jurisdiction and reduce administrative burden. Sites and researchers can partner to improve quality, attain necessary certifications, and increase overall efficiency. Central to all of these are clinical research organizations that can coordinate and work across borders to make clinical trial projects seamless. Ultimately, patients will benefit as quality of clinical practice improves and access to new therapies is enhanced. </jats:p>

Opportunities and challenges for decentralised clinical trials in sub-Saharan Africa: a qualitative study

“…However, in sub-Saharan Africa, as the African Medicine Agency and regional African Medicines Regulatory Harmonisation authorities were not fully operating, most of national regulatory authorities have thus far not revised their guidelines. This contributed to the gap in DCT implementation and their oversight by both ethics and regulatory authorities 40. Investigators and sponsors could play an important role for regulatory and ethics bodies by providing them with updated information and training on available digital and decentralised solutions 8.…”

“…This contributed to the gap in DCT implementation and their oversight by both ethics and regulatory authorities. 40 Investigators and sponsors could play an important role for regulatory and ethics bodies by providing them with updated information and training on available digital and decentralised solutions. 8 Furthermore, study protocols should specifically mention the nature, risk–benefit and the rationale of the use of DCTs.…”

Oncology Clinical Trials in Africa: Emerging and Operational Issues

“…Another key operational issue for clinical trials is developing the right alliances. Solarin et al 16 discuss the key stakeholders involved in the clinical trials enterprise, including regulatory agencies, clinicians, researchers, sites, patients, and sponsors. Fostering appropriate relationships among these stakeholders will enhance both the quality and quantity of trials in Africa.…”

Unseen and unheard: African children with cancer are consistently excluded from clinical trials

“…More collaboration is needed between African researchers, research sites and regulatory bodies. 18 Collaboration between national regulatory bodies to reduce the bureaucratic challenges in conducting trials in 54 different African countries with 54 different regulatory jurisdictions will make Africa a lot more attractive to clinical trial sponsors. Similarly, collaboration between African researchers across sites can yield better science and foster mentorship and training opportunities.…”