Clinical trials are the cornerstone of medical advancement, providing critical data that contribute to the development of new treatments and therapies, but the landscape of clinical research in Africa presents a paradox. On one hand, there is a unique and diverse population that could contribute significantly to global clinical research and the pharmaceutical industry. On the other hand, Afrocentric clinical research lags conspicuously behind, hampered by constraints in logistics, infrastructure, funding, human resources, and management. One of the most significant gaps, however, is the limited involvement of the private pharmaceutical and medical sector in clinical research and development, which looms particularly when comparing Sub-Saharan Africa with South Africa or the rest of world.

In Africa, the majority of clinical trial sites are located within academic environments, government funded clinical settings, and teaching hospitals. This trend is attributed to the established regulatory bodies, ethical committees, and institutional review boards that are more commonly found in these large institutions. However, the private sector’s involvement is crucial for a more diverse and robust clinical research environment that can cater to Afrocentric clinical research needs.

While some may question the commitment to ethical and scientific clinical research standards in African countries, Nigeria, Ghana, Kenya and South Africa are all testament to the continent’s capacity with their various established Regulatory Agencies and Clinical Trials Registries that provide open access to information about ongoing and completed trials, ensuring transparency and adherence to ethical principles. Despite this, the concentration of clinical trials within public institutions suggests a disparity in the distribution of research sites, potentially limiting the scope and variety of clinical research in Africa. Could private sites, and independent IRBs for these sites, be the answer?

Private sector participation can introduce more competition, drive efficiency, and potentially lead to more innovation in clinical research. Private companies, especially global pharmaceutical and biotechnology firms, are recognizing the potential in African medical research, offering funding, technological support, and access to clinical trials, which almost exclusively goes to the large academic institutions. This involvement is crucial for accelerating research progress and catering to the unique genetic and environmental factors affecting African populations, but the bottle-necks sometimes created by saturated sites with competing trials, dealing with overburdened and bureaucratic governmental institutions and their IRBs, resulting in milestone delays and other administrative conundrums at the sites available in teaching hospitals, forestalls further involvement, which may be resolved by the creation of privately managed clinical trial sites such as are available in the western healthcare, pharmaceutical and research ecosystem.

The establishment of independent IRBs (IIRBs) for the private sector in Africa is therefore not merely a necessity, but an opportunity to unlock the continent’s potential in clinical research. Independent IRBs can offer a more streamlined and responsive alternative. A robust private IRB framework can attract foreign and local investment into African clinical research, recognizing the continent as a viable site for cutting-edge studies, which can in turn foster local expertise in clinical research ethics, thus building capacity within the continent. By creating a conducive environment for ethical and efficient clinical trials, Africa can significantly contribute to the global pharmaceutical industry and, more importantly, to the health and well-being of its diverse populations.

A Roadmap for Establishing Private IRBs in Africa

To establish private IRBs and enhance clinical research sites in Africa akin to those in the USA and Canada, a structured roadmap is essential

• Policy Framework Development: Collaborate with African governments and Regulatory Authorities to develop policies that encourage the formation of private IRBs while ensuring rigorous ethical standards.
• Stakeholder Engagement: Engage with local and international stakeholders, including researchers, healthcare professionals, and pharmaceutical companies, to build consensus and support.
• Training and Education: Invest in training programs to develop local expertise in clinical research ethics, safety, management and IRB administration.
• Infrastructure Investment: Secure funding for the necessary infrastructure to support Independent IRBs, including technology platforms for application and review processes.
• Pilot Programs: Initiate pilot programs to demonstrate the efficacy and benefits of private IRBs in the African context.
• Public Awareness Campaigns: Conduct public awareness campaigns to highlight the importance of ethical clinical research and the role of IRBs.
• Continuous Evaluation: Implement a system for continuous evaluation and improvement of private IRB processes, ensuring they meet international standards and adapt to evolving ethical challenges.

Private Clinical Research Sites

While these IIRBs are one solution to the regulatory problems, we also need to establish the necessary private clinical trial sites in Nigeria akin to those in the developed global West, and this requires a strategic approach.

Private entities must be willing to invest in creating the robust infrastructure that includes information systems, regulatory considerations, data management, and safety monitoring plans. This foundation is vital for ensuring that trials are conducted ethically and efficiently.

The capacity of local professionals such as doctors, nurses, pharmacologists, epidemiologists, biostatisticians, and data managers in clinical research management needs to be built with hands-on experience within relevant therapeutic areas to ensure that studies are conducted to the best standard. There is already a lot of advancement in this area, but there is always room for more improvement.

Streamlining the approval process for clinical trials, offering incentives for biomedical research, and the formation of Independent IRBs can create a regulatory environment conducive to clinical research. This alignment is necessary to attract more clinical trials to the continent, as collaboration between the public and private sectors potentially generate exponential growth. Such partnerships can also foster trust between researchers, regulators, sponsors, funders, and the community.

Networking with international research organizations can provide access to a broader range of resources and expertise, as well as opportunities for joint ventures and knowledge exchange, while local engagements within communities served by research and trial sites is crucial for understanding the health needs and ensuring that the research conducted is relevant and beneficial to the population.

Embracing digital solutions and patient-centric technologies can enhance the clinical trial experience for participants and improve data collection and analysis.

Developing sustainable funding models, including private sector trial sponsorships of molecules isolated and developed from local flora and fauna, partnerships with international funders and investment in local research initiatives, is essential for the long-term success of private clinical trial sites.

By following this roadmap, we can establish clinical trial sites that contribute to global medical research and address the specific health concerns of the African population. This shift towards a more inclusive and diversified clinical research landscape is not only beneficial for the continent but also for the global community, as it ensures that medical advancements are reflective of and applicable to a wider demographic.

This journey towards establishing private clinical trial sites is one that requires commitment, collaboration, and innovation. With the right strategies and support, the private sector can play a pivotal role in advancing Afrocentric clinical research and improving healthcare outcomes across the continent.

Ready to navigate regulatory challenges seamlessly in your next clinical trial? Contact us today to find out how Fealth Africa can help you.