As an industry, we have seen the benefits of successful risk-based monitoring (RBM) strategies over the last decade. In fact, since the FDA first released guidance in August 2013, adoption has grown rapidly. One survey concluded that as recently as 2016, just 18% of new trial starts employed some form of RBM oversight. Yet, in 2018, more than 60% of new trial starts were using RBM.
But as the size, number, and complexity of clinical trials continue to grow, the standard approach to monitoring — a resource-intensive approach involving regular site visits and source document verification (SDV) — has become costly and is no longer realistic. However, the fundamental principles — protection of participants and assurance of data quality — remain paramount.
In fact, when the U.S. FDA updated its guidance in March 2019, it gave suggestions to encourage the industry to adopt new RBM strategies to continue to support safer, more efficient, and higher quality clinical research. With many sponsors holding back from fully embracing a risk-based strategy, the FDA has begun to encourage and facilitate conversations like its recent public workshop held in conjunction with the Duke University’s Margolis Center for Health Policy.
Former FDA Commissioner Scott Gottlieb has been a longtime supporter of RBM: “The FDA isn’t alone. The advent of precision medicine is challenging the entire medical research ecosystem to develop more efficient approaches to testing and developing diagnostics and therapeutics…including frameworks that are more carefully suited to the kinds of precision technologies that underpin new treatments.”
Implementing an RBM strategy at your organization does not need to be complicated. This paper outlines several key strategies that will allow you to confidently develop an effective RBM approach in your clinical research program, including what is needed for an effective RBM strategy and how you can confidently support your objectives with the right tools and technologies.