Risk-based monitoring (RBM) and risk-based quality management (RBQM) are “central to ensuring the safety of patients in clinical trials, and [are] expected to continue to grow in importance as [trials] become more numerous and complex,” according to a new white paper from the Association of Clinical Research Organizations (ACRO).
However, the paper sounds an alarm for industry. “Unfortunately, some view RBM as an end in itself rather than as a tool within a holistic quality-based system, and in some cases may simply attempt to fit an RBM strategy on top of an already developed protocol,” ACRO writes in the white paper, “Establishing Risk-Based Monitoring within a Quality-Based System as ‘Best Practice’ for Clinical Studies.”
“RBQM is an integral part of a successful multisite clinical trial,” agreed ACRP Executive Director Jim Kremidas. “Now more than ever, it’s critical to train and certify the clinical trial workforce to utilize these tools and advance trial quality,” he said.
There’s room for optimism to be found in the report, though, says ACRO Executive Director Doug Peddicord. “While RBM’s rollout hasn’t been as quick as some regulators might like, our survey shows we’re doing better since 2016,” he said.
RBM is not a new concept, the white paper notes. ACRO internal data claims RBM methodologies were incorporated into only 18% of new clinical trials in 2016, but that number climbed to 41% in 2017 and 61% in 2018. The stats are muddied somewhat, ACRO admits, because there aren’t universal definitions of RBM in place across industry. “Nevertheless, the weight of evidence points to the growing importance of RBM in clinical trial monitoring,” the white paper posits.
In part, contract research organizations (CROs) have expanded RBM programs in response to U.S. Food and Drug Administration and global regulatory guidelines, the white paper said. However, they’re also driven by observing “firsthand how RBM and [related] strategies, when appropriately integrated into a systems-based approach, provide direct benefits to sponsor companies and improve the quality of clinical trial data,” the white paper said.
The ACRO white paper cites several anecdotal examples of how CROs have leveraged RBM to significantly improve overall monitoring quality while lowering costs. A member survey earlier this year revealed respondents posted 28% fewer critical and major findings per clinical quality control visit and a 16% lower mean cost per monitoring visit, thanks at least in part to RBM innovations.
Despite RBM’s impressive track record, there are barriers—some tangible, others imagined—slowing its adoption, ACRO notes. For example, some ACRO member companies reported “misperceptions that traditional monitoring methods are lower risk, that the strategy of checking every data point is safer, and that complete [source data verification] is the best way of ensuring data quality.”
Beyond the typical resistance to change and garden variety change management issues, there also lies a deeper challenge to address, the white paper says. There is a general lack of knowledge about the RBM process in the clinical trial industry, including “misperceptions about cost benefits and lack of knowledge about evidence supporting the use of RBM.”
“There’s reluctance among some sponsors who mistakenly believe 100% source data verification is somehow safer,” Peddicord says. “That’s not the case,” he adds.
Author: Michael Causey