Reducing monitoring costs continues to be the primary driver to adopting risk-based monitoring (RBM). But should that be the leading metric?
Traditional on-site monitoring visits are a large part of a clinical study budget due to the time and travel costs associated. In an effort to "show oversight", sponsors have been scheduling on-site monitoring visits at fixed intervals (e.g. every four weeks, every two months) at all sites. This monitoring model does not take into consideration that one site may be performing poorly and require more oversight (increased frequency of visits and amount reviewed during those visits), while another site may be running smoothly without the same need, draining critical resources. When the US Food and Drug Administration (FDA) finalized its guidance on RBM in 2013, most of the industry concluded that the FDA was allowing sponsors to slash on-site monitoring and therefore significantly reduce costs.
However, cost reduction was not the point of FDA's guidance. The guidance encourages flexibility in the monitoring model to drive data quality and patient safety by introducing a centralized data monitoring approach. This allows sponsors to start spreading the monitoring oversight across different roles within their organization (e.g. stats, data management, safety reviewers). To ensure efficient oversight across these functions, tools have been created to collect data from various electronic data sources and analyze the data to identify outliers and trends in order to find high-risk sites. A key benefit of the updated FDA guidance on RBM is that it allows sponsors to make more strategic decisions based on this data versus sending a monitor to each and every site. You may find that the same number of overall site visits are required, but only a few of your sites may require monitoring every two to three weeks while the remaining sites only need an on-site visit every five to six months. Focusing your resources on high-risk sites improves data quality, increases protocol compliance, and provides early insight into potential red flags.
Therefore, the answer to the question, "What are the benefits of RBM?" should not focus on reducing monitoring costs, but instead on improving the quality of the data, ensuring patient safety, and thereby the overall success of your clinical trial.
Where are you with your RBM implementation? What is your key driver for success?
Feel free to drop me a line at Crystal.Stone@bioclinica.com if you would like to see a demonstration by our Compass RBM technology and implementation team. No matter where you are in the process, I'm sure we can help!
More about Compass:
Compass is an extensive, source data agnostic, SaaS platform, designed to support and enable RBM. Key benefits include:
- Calculates quantitative and qualitative performance metrics
- Provides targeted action recommendations based on real-time site performance
- Produces overall site quality score
- Surfaces performance trends over life of study
- Acts as a resource/site performance oversight tool
- TransCelerate aligned