Importance of Critical Thinking Skills in Clinical Trial Management
The 3rd Clinical Quality Oversight Conference, run by Momentum Events in May of 2024, brought together industry leaders to discuss innovative strategies for improving clinical trial management. Conference Co-Chairs, Michael Torok, Vice President and Global Head of Quality Assurance Programs at Genentech, and Sharon Reinhard, a well-known industry leader and independent clinical quality expert, emphasized the need for personalized, adaptive approaches, critical thinking skills, cross-functional collaboration, and the adoption of risk-based methodologies. As they guided the conference, they offered practical examples and case studies highlighting how these strategies can enhance data quality, patient safety, and trial efficiency.
Embracing Change and Innovation in Clinical Trial Management
Torok and Reinhard kicked off the 2024 Momentum Events Clinical Quality Oversight Conference by advocating for personalized, adaptive strategies tailored to each protocol’s specific needs. Torok illustrated this with an example from his experiences, where copying the schedule of activities (SOA) from a previous protocol led to numerous amendments, delays, and increased costs. Reinhard echoed this, sharing her experience with a small biotech company that successfully implemented a risk-based monitoring (RBM) approach by focusing on critical-to-quality (CTQ) attributes, resulting in better data quality and resource efficiency.
They stressed the importance of “no one-size-fits-all” in clinical trial management, highlighting the framework provided by ICH E8(R1) and E6(R2) for proactive quality design and risk management. Reinhard noted recent regulatory guidance encouraging risk-based and quality-by-design (QbD) approaches, citing a workshop where regulators praised a company’s detailed risk assessments and tailored mitigation strategies. Their examples highlighted the need for tailored methodologies that resonate with the audience and set the stage for the conference’s discussions.
The Necessity of Critical Thinking Skills in Clinical Trial Management
A key theme of the conference was the importance of critical thinking skills in clinical trial management. Torok and Reinhard emphasized that understanding the intricacies of protocols and aligning them with business objectives is essential. Reinhard described a recent site audit where her team focused on key processes like drug accountability and administration rather than exhaustive data verification. This shift allowed them to identify and address potential issues more effectively, demonstrating the value of critical thinking in maintaining data integrity and ensuring patient safety.
Torok added that critical thinking is crucial for customizing work to CTQ attributes. He shared a scenario where his team adapted a generic monitoring plan to a specific study through thorough discussions identifying unique risks. This cross-functional collaboration led to a tailored monitoring plan that improved study outcomes. These examples highlighted the need to move beyond rote compliance to a proactive, thoughtful approach in clinical trials, encouraging attendees to develop critical thinking skills within their teams for better problem-solving and continuous improvement.
Both Torok and Reinhard accentuated the importance of hiring critical thinkers, those quality professionals with the right combination of emotional intelligence, regulatory expertise, and a flexible/growth mindset to effectively navigate this evolving field.
Breaking Down Silos: The Importance of Cross-Functional Collaboration
Another major theme was breaking down silos and fostering cross-functional collaboration in clinical trials. Torok shared an example from Genentech: a cross-functional team redesigned a trial protocol, including clinical development, data management, and patient advocacy. This collaboration led to a more patient-centric design, improving recruitment, retention, data quality, and regulatory compliance. Reinhard highlighted that smaller companies excel in cross-functional collaboration due to their nimble structures. She recounted a case where a small biotech firm successfully integrated feedback from patient advocacy groups and site personnel into their trial design, resulting in higher participation rates and better trial performance.
Both speakers stressed leveraging the expertise of service providers, such as CROs. Reinhard mentioned a company that worked closely with a CRO to develop a risk-based monitoring plan, tailoring the approach to specific trial risks and enhancing efficiency and quality. They advocated regular cross-functional meetings and workshops to facilitate open communication and knowledge sharing. For example, a workshop where clinical operations and data management teams collaborated led to streamlined data collection processes, faster analysis, and improved decision-making. These insights emphasize that breaking down silos and fostering collaboration is essential for navigating the complexities of clinical research and achieving better outcomes for patients.
Adopting Risk-Based Approaches in Clinical Trials
A key takeaway from the conference was the push towards adopting risk-based approaches in all aspects of clinical trials. Torok and Reinhard discussed how implementing risk-based monitoring, auditing, and data analytics can focus efforts on issues that truly matter, improving trial efficiency and effectiveness. Torok explained how RBM helps prioritize significant risks to patient safety and data integrity. For example, at Genentech, RBM focused on high-risk sites and critical data points, reducing the overall monitoring burden while enhancing issue detection. Reinhard shared a story about pre-pandemic investigator meetings where principal investigators (PIs) challenged protocol criteria, highlighting early feedback’s importance in reducing later amendments and improving trial outcomes.
Reinhard also highlighted a company using risk-based auditing to focus on high-risk processes and sites, enabling early detection and corrective actions. Torok and Reinhard emphasized integrating data analytics in risk-based approaches for real-time insights into trial performance. For instance, one company used analytics to spot non-compliance trends at certain sites, allowing prompt intervention. They advocated for a risk-based approach in study design, assessing potential risks early and designing protocols to mitigate them. Overall, adopting risk-based approaches was presented as essential for improving trial outcomes by prioritizing high-risk areas, engaging stakeholders early, and leveraging data analytics for early detection.
Investing in Skill Development for Clinical Trials
Investing in skill development was a crucial theme at the conference. Torok and Reinhard emphasized the importance of cultivating operational expertise critical thinking skills, and encouraging open communication for successful clinical trials. Torok shared an initiative at Genentech where scenario-based workshops helped employees tackle real-world problems, such as managing a sudden increase in adverse events. This hands-on approach improved team members’ ability to handle challenges effectively. Reinhard highlighted a mid-sized pharmaceutical company’s mentorship program that fostered open dialogue and knowledge sharing, ensuring issues were addressed promptly and effectively.
Reinhard also stressed the importance of cross-functional training to ensure all team members understand various aspects of clinical trials. She mentioned a biotech company that organized workshops bringing together teams from clinical operations, data management, regulatory affairs, and quality assurance. These sessions promoted a collaborative environment by clarifying each function’s role. Both speakers advocated for continuous learning opportunities, with Torok mentioning Genentech’s program that subsidizes professional certification courses. This investment in ongoing education enhances individual skills and the organization’s competitiveness, promoting a proactive and collaborative approach to clinical trial management.
Summary
The 2024 Momentum Events Clinical Quality Oversight Conference highlighted the imperative for the clinical research industry to evolve. Torok and Reinhard’s insights into personalized trial strategies, critical thinking, cross-functional collaboration, and risk-based approaches provided a comprehensive roadmap for improving clinical trial outcomes. Their emphasis on proactive quality management and continuous skill development resonated with the audience, encouraging adoption of these practices to achieve better, more efficient trials.
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%.Â
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.