October 13, 2023

Elevating Lab Standards and Embracing Good Clinical Laboratory Practice in Sub-Saharan Africa

The clock never stops ticking in the world of HIV vaccine research. As the sun sets in one part of the world, somewhere in sub-Saharan Africa, a scientist is looking through a microscope, determined not to rest until a solution is found. This is the story of relentless commitment, not just of those scientists but of an entire network working tirelessly behind the scenes to ensure that every drop of sample, every piece of data, and every result is as accurate as it can possibly be.

GCLP training group photoLab managers with the ADVANCE Clinical Research Center partners, and the IAVI Lab Quality Assurance team, pose for a group photo during a three-day Good Clinical Laboratory Practices workshop in Nairobi, Kenya. Credit: IAVI. Click image for full size.

Vaccine development isn't a walk in the park. It's a journey punctuated by multiple stages, each as critical as the last. From the preliminary research to pre-clinical tests, and onto the various phases of clinical trials, each stage requires precision, dedication, and above all, trust in the systems in place. Trust that the labs, where crucial tests are conducted, will yield results that reflect the truest picture. The findings, whether of experimental drugs, vaccines or biomedical inventions, rest significantly on the accuracy of these lab results.

Here's where the challenge lies. In the heart of sub-Saharan Africa, where the need for an effective HIV vaccine is most dire, there's an equally dire need to ensure that laboratories match international standards. Clinical trials, after all, do not operate in isolation. They are part of a vast interconnected system where lab operations play a pivotal role. Recognizing this, IAVI, through its ADVANCE program, has been on a mission to advance HIV vaccine research in Africa by ensuring that the backbone of research – the labs – are not just functional but meet a world-class standard.

Central to this pursuit is the concept of Good Clinical Laboratory Practice (GCLP). Think of GCLP as the gold standard, ensuring that lab results are not just accurate, but also comparable, repeatable, and auditable across the board. This isn't just about adhering to a set of guidelines but about creating an environment where quality isn't an aspiration but a culture. IAVI has been instrumental in making this a reality, partnering with clinical research centers (CRCs) in Eastern and Southern Africa.

From ensuring GCLP compliance, accrediting labs, and establishing an external quality assurance program, to funding state-of-the-art equipment and training staff, the list of IAVI's contributions is long and transformative – all enabled by the generous support of USAID through PEPFAR. The equipment, especially in a region where maintenance can be a challenge, is no longer just about machinery but about ensuring continuity in the relentless quest for a vaccine. As a result, standard operating procedures recommended by global health bodies, such as the World Health Organization, have been developed and maintained, further emphasizing the commitment to quality and consistency.

Moreover, the comprehensive training provided by IAVI every year has not only ensured compliance with international standards but has also empowered the local workforce, thus contributing to the sustainability of these projects.

Vernon Musale, lab manager, CFHR Zambia, movingly recalled that, “In these trainings, lab managers openly discuss challenges they face while seeking input and guidance from their peers. There is a lot of knowledge transfer that takes place as a result of us being in close proximity to each other over a couple of days.” He continued by narrating his experiences from the initial training phases, emphasizing how these interactions have significantly shaped his understanding and passion for GCLP.

Fast forward to the recent training in Nairobi, held from Sept. 19 to 21, where all lab and quality assurance (QA) managers converged to share the quality systems they had implemented at their sites. This collaborative setting, facilitated by IAVI’s laboratory quality assurance team, Bashir Farah, Mercy Mshai and, fostered an environment where participants garnered a deeper appreciation for the myriad systems and techniques in place across different facilities.

As Musale aptly puts it, “There are many paths to quality, and it is great to be in the presence of people who are all heading towards one goal: quality beyond compliance.”

“The core of these trainings lies in their structure, allowing lab managers to collaboratively learn and address challenges. The network's strength is its diversity, with managers bringing decades of experience. Over 35 seasoned professionals unite with a singular goal: advancing clinical research, leading to unmatched synergy,” stated Bashir Farah, associate director, laboratory quality assurance, Africa, IAVI.

He emphasized the importance of nurturing a culture of quality for sustained productivity and efficiency. Farah also highlighted the necessity for lab managers to embrace the Kaizen principles of ongoing improvement and positive change.

Echoing the sentiment, Irene Mwangi, lab manager at KAVI-ICR in Kenya, stated, “Every lab professional eagerly anticipates the IAVI Advanced GCLP workshops. The 2023 workshop offered valuable insights and a platform for CRCs to discuss their quality assurance approaches. Through shared experiences, we realized the importance of ’quality beyond compliance,’ emphasizing the adoption of best practices over mere regulatory compliance.”

This intensive capacity-strengthening effort has created centers of excellence that stand out in their adherence to global standards of clinical research, data management, and laboratory practices. These centers are now well-equipped to tackle emerging health challenges, drawing increased collaboration and opportunities. The GCLP accreditation and consistent quality checks ensure that these research sites are at par with any international laboratory setting, thus boosting the credibility and acceptability of their research findings.

As with all ambitious endeavors, challenges persist. Adapting global standards to local priorities, for instance, requires not just resources but also a deep understanding of the region's unique dynamics. This model can be replicated and scaled for other diseases and in other resource-limited settings, creating a lasting impact on global health research. As the search for an HIV vaccine continues, it's essential to recognize the unseen heroes – the labs and their dedicated teams. We are reminded that, in this journey, every cog in the machine, especially the labs, plays an indispensable role in turning the dream of an HIV-free world into a reality. The race against HIV doesn't stop, and neither do they.

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