The latest buzz in clinical research is 'risk-based monitoring'. Describing a project management approach that focuses only on the most important data, it is seeing a surge of adoptees throughout the industry. Shantal Feltham, president and CEO of Stiris Research, explains the probable benefits while counselling caution.
A shift is underway in clinical research. With diminishing resources across the industry, sponsors and CROs alike are under pressure to cut costs and reduce drug development pipelines. As such, they are seeking to drive efficiencies through a variety of innovative strategies.
One such strategy is risk-based monitoring. Currently causing a buzz at conferences, this approach is evolving rapidly, and may soon replace traditional means of monitoring clinical trials. "I think it's going to be embraced," says Shantal Feltham, president and CEO of clinical trials management company Stiris Research. "Some people are afraid to try it, some people are curious about trying it, and some people have jumped in with both feet and they're running with it. But this is the direction we're heading in."
Historically speaking, clinical monitoring was a labour-intensive process. With the benefit of additional resources and personnel, the industry could afford to undertake an extremely thorough approach, and 100% source document verification (SDV) became routine. In practice, this meant comparing every data point on every case report form against the subject's medical records. It became a major component of a clinical research associate's (CRA's) career.
Today, the emphasis is changing. The time spent on SDV checks is dropping, and CRAs are adopting a highly targeted approach. Through focusing on the most salient information, there is the potential to improve protocol adherence and trial validity while saving time and money.
"We're used to going out every x number of weeks and monitoring 100% of the data, but there isn't always value in making sure that someone's height or weight is the same between visits," says Feltham. "People are asking, where are our risks, as those are the most important things to take care of. We can spot check the others, but I can't afford to pay someone to look at data that isn't going to provide a ton of value."
This new risk-based monitoring approach will help CROs channel their efforts into the areas that will make the greatest difference. Starting with a risk assessment, project managers align their monitoring strategy with the challenges discerned, and aren't afraid to tweak it should these risks change.
Because the movement is still in its infancy, the pros and cons of risk-based monitoring have not yet been fully evinced. That said, any site should stand to see various advantages. Because there are fewer data points to check through, site visits will become less frequent. This in turn means a reduction in micromanagement and more time available to focus on the patients.
From the project manager's side, the hours that were previously spent travelling between sites can be focused on analysing the data. "Instead of us being on-site for a full day, now I can review the site in four hours; and in half an hour to an hour, I can gather all the information from the study coordinator," says Feltham. "And it's not going to be the minutiae of checking everyone's work, but simply making sure everything's OK."
Trends, meanwhile, will become quicker and simpler to spot. "Pharma will have fingers in the data much more rigorously than before," she continues. "We're more intimate with what's going on, and we're not working in silos - we're looking at the bigger picture."
All this said, Feltham is keen to dissuade companies from jumping in too blindly. While risk-based monitoring will indeed cut pass-through costs, the overall cost-savings are not so dramatic as certain sponsor companies are prone to believe. It pays to maintain a level head.
Stiris, for instance, is monitoring an oncology trial that used to involve visiting sites for two days every quarter. Following the advent of risk-based monitoring, this journey now occurs just twice a year, and on-site expenses have therefore been slashed. From the project management side, the hours that were previously spent travelling between sites can be focused on analysing the data.
"Instead of CRAs being on-site for a full day, now they can review the data in four hours; and in half an hour to an hour, they can gather all the information from the study coordinator," says Feltham. "And it's not going to be the minutiae of checking everyone's work, but simply making sure everything's OK."
Another common misconception is that companies can save money through recruiting beginners. "A lot of pharma companies believe they need young CRAs who have never done the job before, because it's just sitting and looking at data," Feltham says. "But that's not actually what you need. What we're finding is that the more seasoned CRAs bring critical experience to the table."
Perhaps more insidiously, risk-based monitoring lays itself open to worries because of the sheer quantity of work performed offsite. This was not something Feltham had anticipated starting out.
"From the site side, there were things we hadn't even considered," she says. "The sites were afraid they weren't being monitored, which is interesting because we're looking at the data more now than before. So what we've done is to incorporate a phone call, realising that the sites won't really feel comfortable unless you keep them informed."
Over the year that Stiris Research has been involved with risk-based monitoring, it has surmounted these early hurdles and its approach has adapted and evolved. Rather than applying a single strategy, the company has seen a number of iterations on how the project management can be performed. It is now keen to apply the lessons learned.
Risk-based monitoring is undoubtedly a work in progress. Unusually for such a highly regulated industry, the guidance document is broad, opening the door to entrepreneurial thinking. Stiris for one endorses an open-ended approach.
"Our entire attitude is to hire the best, give them latitude and create that entrepreneurial environment where it's safe to make mistakes," says Feltham. "They're not afraid to try new things and share what they find with other companies. Being able to share information fearlessly is what will help drive the process."
So what are the factors common to all successful strategies? "The most important advice we can throw out is to get organised internally before you roll it out externally," she says. "Set up a monitoring plan, train your team, let them know what questions you're expecting them to ask the study coordinator. You need to make sure everyone's on the same page."
Rather than simply flipping the switch, and expecting everything to run smoothly, it is crucial to keep all parties informed of changes. Through creating an inclusive set-up, a site can reap the benefits across its workforce. Once aware of the advantages, they will be more willing to embrace the shift, perceiving a greater degree of ownership over the process.
Stiris Research, as a leader in the field, is learning in tandem with its customers. Offering comprehensive study management solutions for phase I through to phase IV clinical trials, the company provides tailor-made services in line with clients' objectives. In fact, it is as much a consultancy firm as it is a CRO. It adopts a highly personnel-based approach, recognising that if you start with the right people, leading a team to data lock can consume fewer of your resources.
What seems clear is that risk-based monitoring will prove invaluable in the years to come. "We're not going to stop going to sites and we're not going to stop having that face-to-face interaction," says Feltham. "But I think where we're going is risk-based and very value-driven, looking only at the data points that make a difference. Risk based-monitoring will be a huge part of the future."