Article penned by Lutchmee Nobaub, CEO of Clinear Research and Robert M. Karanja, Cofounder & Chief Innovation Officer, Villigro Africa.
On May 20th we will celebrate Clinical Trial Day to recognise the unrelenting efforts and significant contributions of the clinical trial fraternity to advancing medical knowledge, developing new cures, and improving global health.
The field of clinical trials has undergone significant changes and transformations from James Lind’s pioneering work to the present-day context of COVID-19. These changes are driven by scientific advancements, regulatory frameworks, globalization, technological innovations, and the pressing need to address global health challenges including the need for diversity and inclusion.
Diversity in clinical trial participants is essential to ensure a comprehensive understanding of the efficacy and safety of drugs or treatments for all users. Unfortunately, clinical trial diversity globally is sorely lacking. An article published in Nature Reviews revealed that 76% of clinical trial participants in 2020 were White worldwide. Meanwhile, only 11% were Asian, and 7% were Black [1]. A Phesi analysis published in 2022 noted that 40% of US cancer clinical trials did not have a single Black patient, despite Black Patients having the lowest cancer survival rates [2].
We note that the inclusion of underrepresented populations, including racial and ethnic minorities in research studies is essential in promoting health equity, enhancing generalizability of results, and reducing health disparities. Decentralizing clinical trials to Africa, including countries like Mauritius, presents an opportunity to harness the continent’s vast population and genetic diversity. The African populations, representing 16.72% of the world population, exhibit greater genetic diversity compared to non-African populations, owing to evolutionary adaptations to diverse climates, diets, and exposure to infectious diseases and bears more than 25% of the global disease burden and produces only 2% of the world’s research output [3,4,5]. By conducting trials in Africa, researchers can gather data that better represents the global population and develop treatments and interventions that are more effective and applicable to diverse populations.
Upcoming challenges would be to show that many African countries possess the necessary conditions to conduct state of art clinical research, including Regulatory Environment, Infrastructure, Expertise, and Collaboration.
Regulatory Environment: Many African countries have established regulatory frameworks and ethical guidelines for conducting clinical trials. These regulations ensure the safety and well-being of participants and uphold ethical standards in research. More recently, the vision of having a pan-African regulatory authority is turning into reality. The Treaty for the Establishment of the African Medicines Agency (AMA) came into force on 5th Nov 2021 after ratification by Cameroon as the 15th AU Member state. To date, over 60% of AU member states have ratified the treaty, with Rwanda ably taking up the mantle of leadership to serve as the headquarters of AMA as it transitions into an operational organization.
Infrastructure and Capacity Building: Several African countries have been investing in healthcare infrastructure, including research facilities, hospitals, and laboratories. These resources provide a solid foundation for conducting clinical trials and supporting research activities. Since our creation, we have been investing in training and capacity-building initiatives for local staff, providing research methodology training, and ethical considerations to enhance their expertise and understanding of conducting trials with diverse populations. Our next challenge would be providing a standardised African training program.
Local expertise and Collaboration: African countries have a growing research community consisting of experienced researchers, healthcare professionals, and institutions. Collaboration between local investigators, international sponsors, and research organizations can foster knowledge exchange, capacity building, and scientific advancements.
Economic Impact: Clinical trials bring economic benefits to host countries, including job creation, investment in healthcare infrastructure, and the potential for local industries to participate in research activities. The clinical trial industry can contribute to economic growth and development in African countries.
By leveraging these strengths and opportunities, African countries can play a crucial role in advancing medical research, improving healthcare outcomes, bridging knowledge gaps, promoting equitable access to healthcare, and strengthening public awareness and health Literacy.
Clinical Trial Day serves as a reminder of the pivotal role clinical trials plays in advancing medical knowledge and improving patient care. Our concluding note is that Diversity and inclusion in clinical trials are vital to creating an equitable healthcare ecosystem. We have to ensure medication safety by the development of the right treatment, given to the right patient, at the right dose and at the right time and that patients across the globe can own their health journey.
REFERENCES:
- Sharma, A., Palaniappan, L. Improving diversity in medical research. Nat Rev Dis Primers 7, 74 (2021). https://doi.org/10.1038/s41572-021-00316-8
- Alivia Kaylor: Addressing Racial Inequities in US Cancer Clinical Trials https://pharmanewsintel.com/features/addressing-racial-inequities-in-us-cancer-clinical-trials
- Schemm Y. Africa doubles research output over past decade, moves towards a knowledge-based economy. Research Trends. 2013 issue 35. https://www.researchtrends.com/issue-35-december-2013/africa-doubles-research-output/.
- Blom A, Lan G, Adil M. Sub-Saharan African science, technology, engineering, and mathematics research: a decade of development. Washington, DC: World Bank Publications; 2016.
- United Nations Educational Scientific and Cultural Organization. UNESCO Science Report – Towards 2030. UNESCO Publishing. Paris, France. 2015.
