Clinical trials are crucial for public health in Africa, where diverse health challenges require thorough evaluations of medicines, vaccines, and medical devices. Beyond assessing safety and effectiveness, these trials enhance health systems and local capabilities. However, their success depends on robust biosafety and biosecurity practices.
The WHO Joint External Evaluations (2016–2019) and the 2019 Global Health Security Index have identified significant weaknesses among African Union member states. Strengthening biosafety and biosecurity is essential to protect public health and support clinical research, which is crucial for detecting pathogens and monitoring antimicrobial resistance.
Addressing these vulnerabilities is critical for the future of clinical research and public health in Africa, as trials detect important organisms and identify emerging patterns of antimicrobial resistance in the population.
Biosafety in Clinical Trials: Protecting People and the Environment
Biosafety involves principles, technologies, practices, and procedures to prevent unintentional exposure to biological agents and toxins (WHO, 2020). In clinical trials, these principles are crucial for handling investigational medicinal products (IMPs) containing biological agents and managing participant samples. Worryingly, the absence of standard biosafety and biosecurity measures for containing hazardous infections has been documented across the continent (Abdi et al, 2024).
The practical application of biosafety principles in clinical trials requires strict containment measures, consistent use of personal protective equipment (PPE), and adherence to safe laboratory practices. Regulatory and ethical reviews are conducted as part of the clinical trial approval process, and site assessments are conducted to ensure that good laboratory practices, including robust biosafety standards, are in place at clinical trial sites.
The study protocols are designed to minimise the risk of accidental release of dangerous pathogens during their use. A primary focus of biosafety in the context of clinical trials in Africa is to protect human health and the environment from potential risks associated with the biological agents used in research on the continent. For example, developing cholera vaccines involves manipulating active cholera bacteria to create non-toxic strains that induce immunity. In such cases and all clinical trials involving biological agents, effective and robust biosafety practices are essential to minimise the risk of accidental release of these highly toxic agents.
Clinical trials in Africa often focus on pathogens endemic to the region, which can pose significant health and environmental risks if not handled properly. Therefore, stringent biosafety measures are crucial throughout the clinical trial process, from the handling of investigational medicinal products to the safe disposal of waste. This requires a thorough understanding of the biological agents’ characteristics, including their infectivity and pathogenicity, while considering the continent’s unique ecological context. The U.S. Clinical Laboratory Improvement Advisory Committee highlighted the importance of these biosafety measures after the 2016 Ebola crisis, emphasising the need for improved protocols for handling infectious agents.
Biosecurity Imperatives for African Clinical Trials: Preventing Deliberate Misuse
In a historic biosecurity incident, a Queensland laboratory lost 323 live samples of deadly viruses, including Hendra, hantavirus, and lyssavirus, with the breach only discovered in 2023 (Southwell & Hunter, 2024). This highlights the urgent need for stricter oversight of dual-use research and underscores the serious implications of biosecurity failures. While biosafety prevents accidental exposure, biosecurity protects against theft or intentional release of dangerous pathogens. To safeguard public health and national security, robust measures such as controlled access, thorough vetting, and comprehensive material accountability systems are essential.
The African continent poses unique biosecurity challenges for clinical trials, including porous borders, political instability, and the risk of biological agents falling into the wrong hands. Therefore, biosecurity measures must be tailored to the region’s vulnerabilities and include strategies beyond physical security, such as thorough personnel vetting. The Indivisible Link: Why BSBS Matters for African Clinical Trials
The Africa CDC launched the Biosafety and Biosecurity (BSBS) Initiative to help African Union Member States meet global biosafety standards. Supported by the Government of Canada through the G7-led Global Partnership Against the Spread of Weapons and Materials of Mass Destruction, this initiative emphasises strong BSBS national policies and effective oversight of dual-use research of concern (DURC).
ACRN is entirely behind these efforts. We believe guaranteeing the highest possible standards of biosafety and biosecurity is not merely an operational necessity but a fundamental ethical imperative. The integrity and reliability of the research data generated through clinical trials are inextricably linked to the rigour of the biosafety and biosecurity measures. We further recognise that lapses in biosafety and biosecurity safeguards compromise the validity of clinical trial findings and erode trust in clinical trial capacity.
Conclusion
The threat of emerging infectious diseases such as Ebola, in addition to concerns about bioterrorism and accidental releases of harmful agents, highlights the need for strong biosafety and biosecurity measures worldwide, including in Africa. Clinical trials involving biological agents require stringent protocols and standard operating procedures to protect trial participants, researchers, communities, and the environment.
Sources
Abdi, A. M., Abdiweli, A. S., Sheban, H., Ali, A. A., Sead, H., Hussein, M., Mohamed, Z., Dayib, M. & Kosar, H. (2024): Biosafety and Biosecurity in Africa: Challenges and Future Perspectives. Accessed: https://www.researchgate.net/publication/377264685
Africa Centres for Disease Control and Prevention (Africa CDC) (2021): Africa CDC Biosafety and Biosecurity Initiative Report on the Consultative Process to Identify Priorities for Strengthening Biosafety and Biosecurity. Accessed: Africa CDC Biosafety and Biosecurity Initiative Report on the Consultative Process to Identify Priorities for Strengthening Biosafety and Biosecurity – Africa CDC
Centers for Disease Control and Prevention [Internet]. Atlanta (GA): Clinical Laboratory Improvement Advisory Committee; c2016 [cited 2019 Mar 1]. Summary Report: April 13–14, 2016. Available from: https://ftp.cdc.gov/pub/CLIAC_meeting_presentations/pdf/CLIAC_Summary/cliac0416_summary.pdf
Meechan, P. J. & Potts, J. (2020). Biosafety in Microbiological and Biomedical Laboratories 6th Edition. U.S. Department of Health and Human Services. https://campus.und.edu/safety/_files/docs/biosafety-in-microbiological.pdf
Southwell, D. & Hunter, W. (2024). Hundreds of vials of DEADLY viruses have gone missing from a laboratory – and scientists warn they could be ‘weaponised’. Accessed here: https://www.dailymail.co.uk/news/article-14172087/Virus-samples-missing-lab-Australia-major-biosecurity-breach.html
World Health Organisation (2020). Laboratory biosafety manual. Geneva: WHO. [Google Scholar]
Author: Tatenda Magetsi | ACRN’s Policy and Advocacy Manager