While Risk Based Monitoring (or RBM) has been a topic of discussion in the clinical research community for a long time now, many sponsors and researchers have been hesitant to make the transition.
RBM is now gathering momentum in Australia and is being hailed by many across the world as a great way to tackle the ever-rising complexity and cost of clinical research, especially on-site monitoring, which is the costliest aspect of running clinical trials.
At On Q Recruitment, we’ve noticed that the conversation around RBM has started to spark up again recently; candidates are contacting us wanting to know more about jobs in this field and clients are seeking Clinical Research professionals that have worked under this new methodology.
We’ve spoken with a number of clients and professionals lately to find out a bit more about RBM and what impact it will have across the board. Although most are unsure what the full effects of it will be, they think an RBM future looks bright for Clinical Research Associates and the industry as a whole.
What is Risk-Based Monitoring? (RBM)
RBM is different to other traditional approaches to monitoring, as it moves away from frequent on-site visits and 100% source data verification (SDV), and instead moves towards centralised digital data collections, virtual workplaces and remote monitoring.
The aim of this new methodology is to increase monitoring efficiency without compromising patient safety or data quality. To do this, it utilises digital technology and Artificial Intelligence (AI) to help with the monitoring and SDV, meaning more remote monitoring. With more remote monitoring, there is less need for CRAs to make as many routine visits.
Trials are also showing that as CRAs are doing more remote calls and monitoring, they are spending less time on site and less time on the administration tasks associated with some of the data collection, such as site file clean ups, which, in turn, has meant some cost savings. This means CRAs can spend less time trawling through data and more time focusing on the risks for each specific trial.
This increased use of digital technology and remote monitoring is seen as having great benefits for RBM with increased quality control, efficiency, and of course cost-effectiveness. Enhanced monitoring means risks can be picked up on, prioritised and managed more effectively. This allows the research to change as and when required to give more attention to particular risks, paving the way for a more proactive and agile approach.
The beautiful knock-on effect of all of this is the enhanced safety of patients.
We’ve heard about several Australian companies who are trialling RBM and how the change has not only allowed them to really focus their resources at areas of risk, but it’s enabled their CRAs to look at the big picture, not just the data points, and find the unusual adverse events.
Sites are also noticing an impact of this change, including as the knock-on effect of CRAs not being on site as often, which means that CRAs are unable to pick up as much of the site workload as they used to and that sites are paid less.
How Will RBM Impact Jobs?
Now, we can hear what you might be thinking. With words like “remote monitoring” and “cost-efficiency”, there are some clear parallels to wider business trends like automation and AI. One of the frequently cited concerns around those trends is that it will result in jobs being eliminated. However, from what we’ve garnered from speaking to clients and professionals in the Clinical Research field, these fears are overstated.
In general, they agree that the introduction of RBM will obviously have a knock-on effect, especially on the role of a CRA, but many see this effect as being beneficial – especially when it comes to job satisfaction. With less time spent on routine visits and SDV, CRAs will be doing what they want to be doing, rather than looking through data, which is great news. As RBM also aims to enhance patient safety, this in turn can have a great impact on the way people perceive the clinical research and the industry.
As with any change in job function, it’s easy to wonder what might happen and whether some roles could be made redundant in the future. However, as people say, when one door closes another one opens, so who knows what other opportunities will be created because of this.
This proliferation of digital technology and AI really echoes the way other industries are using digital technology and Artificial Intelligence to improve cost, speed, efficiencies and quality control. However, from what we’ve heard across the industry so far, we don’t think CRAs have anything to worry about when it comes to the introduction of RBM. This is the way all industries are heading, and what seems to be the way of the future.
