Leslie Sam, President, Leslie Sam and Associates, LLC and Lisa Collins, Co-Founder, Head of Clinical Research at Innomas Clinical Research, presented their experiences from the decentralized malaria clinical trial in Mozambique and Kenya at the 2024 Momentum Events’ Clinical Quality Oversight Forum. The trial faced significant challenges due to the inexperience of local teams and their understanding of GCP compliance. With around 50,000 study participants, including vulnerable populations, the initial plan for study execution relied on remote administration methods, such as paper diaries and electronic clinical outcome assessment (eCOA) systems, which led to issues exacerbated by siloed operations, inadequate training, and data management problems.
Overcoming Challenges in the Decentralized Malaria Clinical Trial
The decentralized malaria clinical trial in Mozambique and Kenya encountered numerous obstacles. Most of the study’s team members were new to clinical research and had inadequate clinical research and GCP training. This deficiency and their siloed approach to the clinical site operations resulted in risks to participant safety and data integrity. For example, cultural barriers impacted data quality, as personnel feared reporting adverse events (AEs) would reflect poorly on their performance, leading to inconsistent and potential under-reporting of AEs (i.e. none reported). Additionally, a flu outbreak was initially misidentified as malaria. Sam and Collins designed and implemented a holistic approach to address these challenges, emphasizing comprehensive training that enabled the prompt detection and management of participants’ safety and data integrity issues. This strategy (which involved Community Engagement Officers) improved communication and equipped site teams to address issues promptly, shifting the focus from compliance to quality and significantly enhancing the trial’s effectiveness and adherence to GCP standards.
Traditional Monitoring Pitfalls in The Malaria Clinical Trial
When Sam and Collins joined the malaria trial midway as Mozambique was ending and activities in Kenya were being initiated, they found the traditional monitoring approach failing. Infrequent and ineffective on-site monitoring visits led to critical data management issues and a monitoring team that did not effectively communicate with site staff or data management, causing delays and mismanagement of crucial enrollment data. Additionally, many local staff from non-medical backgrounds lacked an understanding of gold-standard documentation and protocol implementation. For instance, some lab personnel were unaware of the relevance of specific clinical procedures, e.g., the informed consent process. In response, Sam and Collins overhauled the clinical operational approach in Kenya by redefining roles, establishing clear communication channels, and emphasizing the importance of each team member’s role in maintaining GCP compliance, setting the stage for a successful transition to a risk-based approach to study implementation and quality oversight.
The Complexity of Maintaining GCP Compliance
Maintaining GCP compliance in the trial presented numerous challenges. Many staff members were unfamiliar with basic clinical research principles, causing informed consent processes and documentation issues, such as missing consent forms. These challenges highlighted the need for a flexible, culturally sensitive approach. Sam and Collins implemented a holistic strategy, emphasizing proactive issues identification with communication and approaches sensitive and relevant to cultural norms. This approach significantly enhanced the trial’s effectiveness and adherence to GCP standards, showcasing the importance of adapting oversight relevant to cultural norms.
Conclusion
Addressing these challenges required a comprehensive overhaul of the monitoring approach, which Leslie Sam and Lisa Collins implemented in Kenya. Their holistic, risk-based monitoring strategy emphasized proactive issues identification, comprehensive training, and community engagement. The study saw significant improvements by involving community engagement officers and improving communication. The focus shifted from compliance to quality, enhancing the trial’s effectiveness and adherence to GCP standards. This transformation highlights the importance of adapting clinical trial oversight to study locations’ specific cultural and operational contexts.
Don’t miss the one-day virtual event on September 5th, which summarizes ICH E6(R3) or the 3rd GCP Inspection Readiness Hybrid Conference on December 2-4 in Philadelphia and online. Click here to view the calendar for Momentum Events and use discount code CTV-ICH to save 15%.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
