Despite the disproportionately high burden of disease, the Sub-Saharan region, have geographically and technologically been less to the mainstream scientific community. However, this can be an opportunity for extraordinary change and growth in scientific research, especially in clinical trials for new vaccines and treatments. Indeed, when such a deficiency exists, it inevitably can grab the attention of major industry players. In this article, we highlight the benefits of conducting clinical research and the drivers of clinical trial industry evolution in Africa.
Double disease burden: Demand for proven therapies and vaccines.
Though alarming and tragic on the face of it, having 1.2 billion people suffering from double disease burden comprising communicable and non-communicable diseases, means that there is an abundance of the patient population representing various disease areas, which further indicates an opportunity for rigorous scientific investigation and breakthroughs. Add to it the fact that most of the patient population tends to be comprised of those who are far more willing and eager to participate in studies, one can see how attractive it can be to move research to the continent.
Universities: Increasingly Global Health Players
Africa has become a global health institution. Increasingly, there have been many clinical trial partnerships between Africa’s academic research universities and those from the West. Expatriate biomedical scientists are welcomed to teaching hospitals and public research institutions in Africa to undertake research involving human subjects. Teaching and referral hospitals and African physicians are keen to participate in clinical trials and are hungry for research opportunities and grants for their institutions. The increasing requirement by universities for their staff to contribute to sound scientific advancements and desire to share in the contribution to global scientific knowledge has boosted the rapid demand for research opportunities by the academic staff. Patient and researcher’s priorities in Africa are often n aligned to the needs of pharmaceutical sponsors. The abundance of well-trained English-speaking researchers and the availability of English source documents make Africa continent attractive for conducting clinical trials.
Positive Economic Outlook
The World Bank forecast notable economic growth in different sectors in Sub-Saharan Africa. Annual GDP Growth in Sub-Saharan Africa is forecast to pick up to 2.6 percent in 2017 and to 3.2 percent in 2018. Fiscal adjustment policies have improved macroeconomic growth. Security threats have subsided in several countries and infrastructure investments to sustain growth are improving. Governments and private sectors have become increasingly focused on attracting biomedical research. Encouragingly, some countries such as Rwanda are reportedly building up their gross expenditure on research and development along with a 60% growth rate in the continent’s overall scientific publication output from 2008 to 2014. Keep in mind that this is occurring simultaneously as recent science spending in South Africa, historically the continent’s scientific leader, has slowed. This trend in greater investment in science and technology in Sub-Saharan Africa bodes well for the future of Africa and medical research.
Good Clinical Practice (GCP): Closing the Gap
The International Conference on Harmonization (ICH) is the gold standard for good clinical practice. The organization provides guidelines for technical requirements for registration of pharmaceuticals designed for human use. Under the auspices of the ICH, standards are codified for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. This assures researchers and patients to collect data and report credible results. The ICH guideline also ensures the rights and confidentiality of research participants are safeguarded. Africa has widely adopted (ICH-GCP) guidelines. The continent has significantly improved the safety of research participants. In addition, US Federal Wide Assurance (FWA) Policy for the Protection of Human Subjects (also known as the Common Rule) is fast gaining acceptance by Africa ethic committees and regulatory authorities. Researchers intending to use funds from US agencies to conduct research in Sub-Saharan Africa are required to register with the Office for Human Research Protections (OHRP) and obtain a Federal-wide assurance number. Compliance with FWA Common Rule ensures clinical development in Africa meets the very high U.S standards for clinical trials. Furthermore, knowledge transfer to Africa through the FWA review process has improved quality and timelines for clinical trial application review in Africa.
Global competition: Efficiencies and Cost Savings
The reduction in the amount of time and cost to conduct a clinical trial becomes important, especially as competition to bring a new drug to the market is intensifying. Yet another impetus for clinical trials in Africa is the enormous economic advantages due to the comparatively low cost of doing business. Africa is increasingly becoming a common and cost-effective location for industry-sponsored clinical research. To be more specific, the competitive expense per subject is comparatively competitive due to low operational costs such as clinical supplies, wages, and regulatory fees compared to developed countries. Furthermore, there is often a highly favorable exchange rate made available, which offers sponsors of clinical trials a more accommodating environment.
As the old saying goes, “time is money” so it is important for industry-sponsored clinical trials. In general, the recruitment of study participants in clinical trials is comparatively faster in Africa. Clinical Trial Application contract and budget negotiations have simple procedures with less bureaucracy. Regional harmonization of regulatory frameworks for Clinical Trial Applications (CTA) and medicinal approvals means shorter approval timelines in multiple countries, all centralized through a single submission. Relatedly, the highly centralized healthcare and referral systems mean sponsors will only need access to a single main referral hospital in order to access a pool of patients with diseases.
Trial Data Mandates
The quantity of available Africa-specific scientific evidence of approved drugs and vaccines is often inadequate because clinical trials were conducted in the non-Africa population. Reliable clinical evidence is essential to support evidence of value, efficacy, and safety in the Africa population. In order to close existing widespread gaps in Africa specific clinical evidence, there is a need for consistent effort to conduct clinical trials designed to meet the needs of Africa.
Diversified clinical trial data is essential for market authorization. The Africa population is ethnically and genetically diverse. The diversity in Africa population is genetic and phenotypic and helps in understanding adaptation, complex diseases, pharmacokinetic (PK) and pharmacodynamic (PD) responses to medicinal products. Increasing requirements for diversified clinical trial data requirements for market authorization means pharmaceutical sponsors need to demonstrate product characterization in broad populations during clinical trials.
The world has seen a veritable revolution because of technology, especially in Africa. Most impactful has been a substantial improvement in mobile communication in Sub-Saharan Africa. The mobile industry in Africa continues to deliver the required connectivity and access to a wide range of services. This allows for convenient communication with clinical sites, hospital teams and easy follow-up with clinical trial participants. On the ground, new constructions of rail and roadways, health facilities, and vital connections of more hospitals to the electricity grid, and medical equipment placement and leasing programs between governments and multinational companies such as GE Healthcare have provided sophisticated modern medical equipment to public referral hospitals.
The promotion of Africa as the 21st Century clinical research frontier bodes well for the overall health in Africa. There are great economic and scientific benefits associated with such transformation. As Africa innovation and entrepreneurship competencies are bolstered, a robust and dynamic clinical research industry will emerge. This means improved healthcare, economic opportunities, and a better Africa.