In an era where clinical trials have become increasingly complex, the significance of human-centric risk management was brought to the limelight at the SCOPE Summit Europe 2023. Pioneers in clinical study management, Marta Kocyk, Central Monitoring Lead, Central Monitoring, and Data Analytics, and Agata Zielak, Director at GSK, captivated the audience with their innovative approach to mitigating study failures. They emphasized integrating horizontal thinking and the quantitative assessment of trial risks through Risk Based Quality Management (RBQM) and Quality Tolerance Limits (QTLs).

Emphasizing the Human Element in Clinical Trials

Kocyk and Zielak opened the summit with a compelling message: the human aspect within clinical trials is often the linchpin of success or failure. They presented striking data showing that a considerable fraction of clinical trials do not reach fruition due to human-centric challenges rather than scientific shortcomings. They argued for a shift in focus, suggesting that understanding and adapting to human behaviors and cognitive capacities are just as critical as the scientific basis for a trial.

The Forgotten Challenge: Synchronizing Technology and Humanity in RBQM

The ‘Forgotten Challenge’—the interplay between rapidly advancing clinical trial technologies and the constant of human nature—was a central theme of their presentation. Kocyk and Zielak pointed out that despite the promising potential of RBQM, its adoption is often hampered by a lack of internal consensus. They proposed a dual strategy of communicating the ‘WHY’—the rationale behind RBQM—to engage the human brain’s desire for purpose, followed by the ‘HOW’—the practical application of RBQM strategies in trial settings.

RBQM and the Rise of Horizontal Thinking

Delving into the methodology, the speakers championed ‘horizontal thinking’—a concept that encourages looking across disciplines and silos to identify and manage risks comprehensively. This approach aligns with the neuroplasticity of the human brain, advocating for adaptable and flexible thinking patterns. Horizontal thinking in the context of clinical trials involves a multidisciplinary team working cohesively to predict and preempt potential threats to data integrity and patient safety.

Quality Tolerance Limits: The Quantitative Compass

A novel aspect of their RBQM strategy is the application of Quality Tolerance Limits (QTLs). QTLs serve as predefined quantitative markers that, when surpassed, signal a possible drift in the quality of the trial data. Kocyk and Zielak elaborated on how QTLs are instrumental in maintaining the scientific rigor of trials. They act as a failsafe, ensuring that any deviation from the expected trial conduct or data quality triggers an investigation, thus aligning with the horizontal thinking methodology by bridging the gap between statistical foresight and operational execution.

The Path Forward: A Synergy of Minds and Metrics

The presentation concluded with a future-gazing perspective, envisioning clinical trials where human-centric risk management and horizontal thinking are not mere adjuncts but integral components of the trial design. By marrying the adaptability of the human brain with the precision of QTLs, Kocyk, and Zielak posited a future where clinical trials are more resilient, responsive, and reflective of the complex interplay between human factors and empirical data.

In closing, the insights presented by Marta Kocyk and Agata Zielak have charted a course for a new age in clinical trial monitoring—one where the harmonization of human-centric strategies, horizontal thinking, and quantitative metrics like QTLs pave the way for trials that are not only scientifically sound but also robust against the unpredictable nature of human variability.

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Moe Alsumidaie Chief Editor
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.