According to estimates, traditional onsite monitoring today accounts for almost 33% of the life sciences industry’s $30bn-plus clinical trial spend. Clearly, you have to figure out a way of reducing this percentage, in order to ensure the long-term commercial viability of trials. After all, the resource-intensive, onsite monitoring processes have not really been helped you identify and prevent issues that could affect trial data integrity and overall study quality, as well as participant safety.
Risk-based monitoring (RBM), an alternative to the conventional onsite monitoring approach dependent on comprehensive source data verification (SDV), might offer a way out. Based on the idea that the supervision strategy should be proportionate to identified protocol and program risks, RBM includes identifying, evaluating, tracking and mitigating the threats that could adversely impact study outcomes.
So, what we are essentially talking about here is allocating resources across the trial lifecycle, based on protocol compliance, data criticality and integrity, subject safety, and impact on operational delivery. Such a tailored approach can help pharmaceutical and biotechnology companies, as well as medical device manufacturers, make trial monitoring more effective, while boosting patient safety and data quality.
And, many of your peers are increasingly warming up to the idea. RBM adoption has been doubling every year since 2012, according to the Association of Clinical Research Organizations.
Here are four core elements of a RBM program that you should keep in mind while designing and rolling out such an initiative across your organization:
Data gathering and submission: RBM entails centralized collection and analysis of trial data. Therefore, you must ensure a steady and credible flow of data from every study site to the central monitoring system, either via an automated connection between the onsite data entry system and the central dashboard, or through manual entry and transfer of relevant data.
Dashboard tracking: Set up a dashboard to get a one-stop view of information regarding the status of individual trial locations, with regard to their specific underlying risk factors. If a site is being flagged as “high risk”, then your RBM program would help you take a call on whether to undertake further investigations, spanning exhaustive statistical analysis to onsite data verification.
Statistical analysis: Beside tracking trial risks through the core dashboard, you should also carry out complimentary statistical analyses to proactively spot potential issues. For instance, simple box plots and histograms could be extremely handy in identifying outliers between locations, across different countries, for different risk indicators. And, more advanced approaches like clustering could enable you to identify problematic sites, or even fraud.
Targeted onsite probe: In case your dashboard tracking and subsequent analysis recommend in-person investigations for specific sites, you should undertake the more conventional SDV activity. Therefore, look at SDV as the exception, rather than the norm, once RBM is in place.
By embracing RBM for your clinical trials, you will be able to realize multiple benefits. First, you would uncover more errors in trial processes and data through such centralized automated reviews, as compared to the conventional onsite manual tracking mechanism.
Second, your monitoring costs will reduce significantly, as you would confine onsite audits to only those locations where problems are most likely to occur. Third, centralized risk monitoring via a dashboard, alongside statistical and graphical checks, will help you more swiftly identify outliers or unusual patterns in underlying data. Moreover, you could compare data across different sites to gauge trial performance, trace faulty or miscalibrated equipment, and spot potentially fraudulent data.
Overall, RBM will enable sponsors like you to reduce trial costs, improve data integrity, and enhance patient safety, by proactively identifying and resolving issues during different stages of the study.
Amid growing trial protocol complexity, an explosion of electronic data, and rising scrutiny of resource allocation, RBM represents a new way of tracking and addressing study risks, while ensuring regulatory compliance. With your peers and competitors already experimenting with this approach, why should you be left behind?