Risk-based monitoring (RBM) is the subject of much conversation these days — and a few key misconceptions, which this blog will attempt to debunk.
To level-set, we should start with a definition of RBM. A modified version of traditional clinical-based monitoring, it moves away from scrutinizing every aspect of the trial equally, instead placing the focus squarely on those metrics and activities that have the greatest potential for risk and the greatest impact on patient safety and data quality. By harnessing technological advances, it actually increases data monitoring — so issues are identified early and dealt with before they can balloon — while minimizing site visits. Thus, it both lowers current expenditures and avoids costly potential problems and trial delays. No wonder it is a central component of most quality management strategies.
In November 2016, the International Council for Harmonisation (ICH) revised its guidelines for Good Clinical Practice (GCP). The original guidelines had been established nearly 30 years earlier at a time when clinical trials were both far simpler and almost entirely paper-based. Not surprisingly, the new guidelines reflect the evolution in trial processes, encouraging sponsors to implement more effective approaches to clinical trial design, conduct, oversight, recording, and reporting while continuing to ensure patient safety and reliable trial results. Of course, some of these relate to RBM — just not all. The key RBM-related points include:
- Section 5.0: Quality Management
Implement a risk-based quality management system throughout all stages of a clinical trial, adjusted proportionately to the inherent risk and value of the information at each stage
- Section 5.2: Oversight
Ensure oversight of any trial-related duties and functions carried out on the sponsor’s behalf, including those subcontracted to a third party, such as a CRO
- Section 5.18: Monitoring
Develop a systematic, prioritized, risk-based approach to monitoring clinical trials. The sponsor may choose on-site monitoring, a combination of on-site and centralized monitoring, or centralized monitoring alone, but must document the rationale for their choice
So yes, RBM is addressed in the new ICH-GCP, but as part of a broader quality management approach to clinical monitoring and study oversight.
Myth 2: RBM is just reduced Source Document Verification (SDV)
Source Document Verification (SDV) is a process through which sponsors compare original records to reported information in order to confirm the reliability, validity, and accuracy of trial data. However, that can be an expensive proposition, and its necessity has increasingly come into question. “Reduced SDV” is a more targeted approach that focuses on areas of true risk. Sponsors remotely verify 100 percent of the data associated with patient safety and study endpoints as well as selected other data, freeing more on-site time to be spent managing any risks and other issues as they arise.
So, is that RBM? Just the reverse, actually: The quality management portion of reduced SDV is an important component of RBM — but not RBM in its entirety.
Myth 3: Technology alone can solve RBM
Naturally, technology plays an important role in RBM. After all, an RBM strategy requires the analysis of data aggregated from multiple sources across time, something technology can do extremely well. But holistically, RBM requires a trifecta of people, process, and technology.
- Trained people
The most important component in successful RBM may be the team, a group that approaches data integrity and patient safety collaboratively by identifying risks, mitigating them when possible, then using best practices to monitor further risks and target interventions based on quality problems
- Robust process
A well-honed process helps keep the team on the right path with early and ongoing risk assessments focused on critical processes and data. Risk indicators, action strategies, and thresholds help delineate activities but must allow for the team to adjust monitoring activities in response to identified risks
- Integrated technology
Technology tailored to the unique needs of RBM should enable the process with advanced functionalities that are relevant to the roles the people are required to perform, enabling them to comprehensively manage risks. It must be dynamic, nimble, and above all data-driven. And, of course, it must be able to scale to meet a trial’s increasing complexity
In short: technology supports, simplifies, and advances the people and processes that are essential to RBM.
Myth 4: Machine learning RBM solutions are costly and complex to implement
Implementing any new technology requires some initial expenditures. There is software to invest in, people to train, processes to put in place. RBM is no exception — especially as sponsors often immediately use it for centralized monitoring. With a three-fold goal of improving quality, increasing patient safety, and reducing long-term costs, the benefits of centralized monitoring of patient data, site data, and overall study performance data are clear. Still, that is a lot of data to suddenly be monitoring — a wide net to cast.
However, the advent of software as a service (SaaS) provides a flexible approach to RBM implementation, eliminating the need for large capital expenses. And by directing resources to the areas where they are most needed while minimizing the number of expensive on-site visits, RBM quickly produces significant cost savings.
Myth 5: RBM cuts clinical investigation out of the loop
Not everyone is excited about centralized monitoring. In fact, investigators often worry that reduced on-site monitoring may increase the burden on site staff. Fortunately, studies have shown just the opposite: RBM allows sites to be engaged in the risk-management process in a time-efficient (and therefore cost-effective) way. Instead of hosting on-site visits, site staff can focus on more significant aspects of the trial, such as patient enrollment and compliance. Interestingly, recent surveys report improved site activity and staff satisfaction using a risk-based approach. Meanwhile, the continuous remote monitoring of all data has improved quality because issues are identified and resolved quickly — that must be satisfying for investigators, too.
For more information, check out the recording of our recent webinar, Debunking the Myths of Risk-Based Monitoring for a New Approach to Quality Management.