Dispatches from DIA
Industry shift to risk-based monitoring will change roles of CRAs, experts say
Regulators from the US, EU and industry group TransCelerate have all called for clinical research to shift away from the practice of 100% source data verification (SDV), which can be a costly and time-consuming process, experts from Medidata, InVentiv and Icon said at the 50th annual DIA conference in San Diego.
Marcus Thornton, senior director at Medidata, noted that research companies in 2014 are expected to spend up to $7.5bn on SDV, which isn’t necessarily a smart use of their funding.
In risk-based monitoring studies, CRAs have an increased speed of reviewing and querying clinical data and a reduced time on site, Thornton said.
The issue is that SDV can often seem like a “comfort blanket” for risk-averse sponsors, though sponsors seem more amenable to reducing it over time and will be in favor of more remote and centralized monitoring of trials, he added.
But some seem concerned that risk-based monitoring could eventually make CRAs obsolete, or at least significantly reduce their role in trials. Rita Purvis, VP of clinical operations at inVentiv Health, said CRAs will see the most changes to their positions as new technologies to track trials take off and SDV levels off.
“From on on-site monitoring perspective, this is where the CRA role is really going to evolve and we have to make sure that all of our education, training and change management really focuses on helping CRAs understand the nuances for when on-site monitoring visits are going to become in an RBM [risk-based monitoring] model,” Purvis said. “They’re typically going to be triggered visits based on either key risk indicator threshold breaches, workload, changes in site…or continuing to build site relationships.”
She noted that there are typically between 10 to 20 key risk indicators, though as the data are collected on an ongoing basis, key risk indicators will be refined.
The focus of a visit will also change for CRAs under risk-based monitoring. “Where their time has been diluted in the past because they’ve had to focus on every data variable, even if they’re not critical data variables, now they’ll have more time to actually understand their patients and relationship with the site,” Purvis said.
She also noted that despite some outcry from the industry, risk-based monitoring is not just a cost-cutting tool.
“RBM will require a different skill set [for CRAs], so for any CRAs that have gotten into the habit of just basically the box checking and only doing SDV and not looking at the holistic patient, that mindset will have to change and there may need to be some additional support for CRAs,” Purvis said.
Dermot Kenny, SVP of Icon, sounded even more pessimistic about the role of CRAs in risk-based monitoring, noting that they could eventually become obsolete depending on “how much we embrace technology.”
“Regulators are promoting risk-based monitoring because they believe it’ll produce higher quality data,” Kenny said.