If you've spent time researching risk-based monitoring (RBM) over the past year, you know dozens of academics, CROs, clinical trial practitioners, and statisticians have proposed varied approaches based on sponsor needs and trial designs. Unfortunately, despite an abundance of theoretical perspectives on RBM, clinical trial teams soon discover a significant gap still exists between perspectives and actual tools to enable real-world RBM implementation. The challenge for sponsors remains how to translate theory and methodologies of risk-based monitoring to their unique setting.
Often overlooked in early evaluation of RBM are the tools and technologies required for successful implementation. Without the right tools to track and prioritize the shift from traditional monitoring to RBM, successful implementation is doubtful, posing detrimental consequences not only for the monitors, but also the overall trial.
For successful risk-based monitoring program implementation, here are the five must-have capabilities of an effective RBM tool:
1. Ongoing and Continuous Performance Tracking
Trials never go exactly as planned. The best-intentioned RBM strategy implemented at the beginning of the trial is unlikely to be optimized over the life of the trial. Some sites will not perform as well as expected, while others will surpass projections. Primary investigators and research staff churn, impacting site performance. A static, one-time RBM plan/strategy simply will not be able to account for the dynamics of a real-world clinical trial. An optimal risk-based tool will adjust by incorporating real-time site performance, site status changes, and sponsor profile changes.
2. Multiple Data Sources
Data in clinical trials are complex and dynamic. The tremendous amount of data collected in a trial offers valuable insight − if harnessed correctly. A solid RBM strategy includes feedback and input from multiple data sources. EDC, CTMS, IVR/IRT, and other study databases contain rich data that when viewed correctly, provide valuable information about how a site is performing and can even predict problem areas. Performance metrics contained in these databases are critical to catching such problems early and preventing significant compliance issues.
3. Incorporation of Monitor Feedback
Without question, RBM tools must incorporate data from clinical trial databases such as EDC and CTMS. This data however paints only a partial picture of what's really going on in a trial. One of the most valuable, yet underutilized, resources for tracking and adapting an RBM plan is direct feedback from the monitors themselves. Who knows better what is really going on at a site than the monitors? The leading RBM tools include a mechanism to capture input from the monitors on the RBM strategy implementation at specific sites.
4. Flexibility and Customization
Sponsors have widely varying needs, strategies and risk tolerances and with no two clinical trials the same. Each trial is designed from the ground up with specific endpoints and objectives. Te tool you choose to implement your RBM strategy needs to accommodate the vast and varying needs of sponsors. During technology evaluation, keep in mind the importance of flexibility and customization unique to your organization's needs.
5. Actionable Reporting
Clinical trial teams are inundated with data from EDC, CTMS, in-house systems, e-mail, phone, and other sources. When implementing an RBM strategy, it's critical the technology provide targeted, actionable information. RBM tools must provide sustained, meaningful reporting that enables trial teams to take action on the issues detected.
Theories rarely live up to their promises to deliver value or return on investment without diligent and careful thought as to implementation – and RBM is no different. RBM demands leading-edge tools to help integrate new monitoring theories, whether in new or existing clinical trials.
RBM has the potential to deliver on the promise of more efficient use of the ever-shrinking pool of funds and resources dedicated to clinical trials while at the same time improving overall monitoring effectiveness. With the right RBM enabling technologies, clinical trial monitoring groups will, for the first time, be able to "do more with less".
Preview Compass Technology
BioClinica's Compass technology is specifically designed to enable successful risk-based monitoring. If you'd like to preview Compass, an on-demand webinar is available to watch at your convenience.
In the meanwhile, if you'd like to talk about RBM or need an answer to a specific question, shoot me an email at Courtney.McBean@BioClinica.com and we'll go from there. I'd love to hear from you.