By Lynn King

July 30, 2013 | Guest Commentary | A risk-based approach to clinical monitoring, with multidisciplinary teamwork to design studies and centralized monitoring, can greatly reduce costs, produce better data, accelerate study timeframes and reduce stress for on-site monitors—improving the way the entire industry conducts clinical research.

While risk-based monitoring has long been used for federal research by the National Institutes of Health, significant opportunities await to use this strategy for commercial research. A risk-based approach with good judgment and sound reasoning can greatly curtail the need for clinical research associates to be road warriors. In some cases, a risk-based strategy could reduce the need for site visits to once a year instead of the industry standard of every four to six weeks. 

The practice of 100% Source Document Verification (SDV) has become a standard “cookie cutter” practice in the way clinical trials are conducted. The practice dates back to 1988 FDA guidance, since withdrawn, that cited personal contact between the monitor and investigator as the most effective way to monitor clinical investigations. It has become a habit—“we’ve always done it this way”—without consideration of how clinical research could be conducted more effectively by incorporating modern communication and computing tools to remove costs and delays. 

Meeting site staff, observing how patients are seen and how drugs are stored, for example, will always require on-site visits. But two years ago, FDA guidance suggested that on-site monitoring for 100% SDV is not always needed. Trial design plans calling for centralized monitoring and targeted SDV (tSDV) on the data that truly matter promise to produce even better data results, reduce costs, and save time. 

To date, commercial sponsors have been slow to adopt this approach without further validation of the FDA’s willingness to approve risk-based monitoring data for clinical trials. It is important to ask if there are success stories for drugs approved using a risk-based approach, how have FDA auditors viewed this approach, and have any FDA warnings been issued on programs that used a tSDV risk-based approach?

Teamwork is Essential

Teamwork and resulting cross-functional communications at every stage of a trial is the cornerstone of how risk-based monitoring can change the way the industry conducts clinical trials. Collaboration across silos leads to data-driven intelligence that can identify and proactively address problems before they occur, such as identifying sites that need additional training. 

This paradigm of a new level of teamwork can improve the organizational culture for everyone involved. Every functional area benefits from a deeper knowledge of what other team members are doing, and quality of data at the end of a trial has the potential to be improved. Each team member understands their role as a contributor and has a better understanding of how the team produces better data quality by working together. 

The collaboration, with important contributions from statisticians and data managers to highlight important trends to monitor, enables stronger customization of project execution and monitoring plans based on the study and sites involved. This approach elevates the already crucial role of the monitor, creating opportunities to use more judgment and make strategic assessments. 

Monitor Burnout Prevention

Of course, best practices in other areas also help alleviate monitor burnout. Hiring remote staff near the project can cut down on travel and commuting time to better manage workloads and reduce stress. It is also important to create a sense of community for remote workers, allowing monitors to get together to share best practices, talk about their challenges, and share solution ideas.

Monitors are multi-tasking experts by nature, and they live with the stress of travel requirements and adjusting to decreased travel options in last few years. Risk-based monitoring holds the promise to address the challenges that monitors confront with enhanced collaboration among the entire team.

The industry is two years into the FDA opening the door for this discussion. Risk-based monitoring can detect errors and variations earlier and increase competitiveness by fostering quicker results and lower development costs. The industry needs to encourage more feedback from the FDA and develop forums to explore risk-based monitoring for commercial research. 

Lynn King is assistant vice president, clinical operations, at Rho, a CRO based in Chapel Hill, N.C. She has20 years of experience in the drug development industry, the last 16 in personnel management, leadership, training and team building.