Risk-Based Monitoring: Understand It Before You Implement It
By Ed Miseta, Chief Editor, Clinical Leader
Duncan Hall, CEO Triumph Research Intelligence (TRI) and Triumph Consultancy Services, is dedicated to helping CROs and pharma firms align their core business processes with the latest technologies. Obviously a lot of his time is currently spent helping clients navigate the difficulties of implementing a proper RBM (risk-based monitoring) plan. Installing the technology is not difficult, but making sure the solution you select properly aligns with your needs can be a challenge.
“The first thing we try to do is ascertain where the company is in terms of capabilities,” says Hall. “One of the things we are seeing in the industry is a broad spectrum of maturity levels across companies. At this point in time no one is particularly mature in the RBM space although some larger CRO and Pharma companies are now clocking up more than 50 studies worth of experience. Some companies are really just starting to get their head around the concept of risk. They are trying to define what exactly risk is and how to properly assess it and manage it. There is also a discrepancy between companies using available technologies to manage risk versus those who are still trying to do it manually. Some CROs are even trying to offshore the entire function. For those reasons, it is so important for us to take the time to understand where a company is and where they eventually would like to be.”
Even when companies are actively assessing risk, they need to be able to define which risks need to be managed and which should be eliminated at the protocol design stage (unnecessary risks, which don’t contribute to the primary intent of the trial). For those which must be managed, companies must then draft a clear plan on how to best manage them, and which function should own them. According to Hall, many companies are ready to jump into new technologies, but do not have a clear view on how they will integrate with their business, their processes and other existing technologies. In those cases, the technology can end up adding less value than it should, and even be a source of confusion.
“I have seen many companies jump into a new technology prior to knowing how it will be used in practice,” he says. “It’s a common mistake many companies make and it can be a very expensive one. People generally don’t get excited by defining new roles and processes, but they do get excited with the idea of using a new technology, even if they don’t fully understand it. Our primary goal is to help customers understand the technology and how it will integrate with the roles and processes within each organization. We also help them to understand what the potential impact of these changes might be on their companies. Only once we understand all of that do we attempt to guide them to the appropriate technologies.”
Ask Yourself This Important Question
Hall believes there is one very important question companies must ask themselves when considering an RBM implementation. They need to know what it is they hope to get out of it. He has seen a lot of companies seduced by promises of massive savings in both time and costs. While those savings are certainly achievable, they can only be realized if RBM is properly implemented.
“Companies really need to ask themselves what the promise of RBM means to them,” he states. “They need to understand how it will help them oversee trials from a quality perspective. Only when they understand what RBM means to them and what their specific goals are will they be able to understand how best to go about accomplishing those goals.”
Hall will help companies answer that question by showing them how to detect risk, how to assess each country, site, or subject versus the study population, and how to identify the correct metrics and indicators to use for any given study, driven by the risk assessment of the trial protocol. Once these steps have been formed, then technology can really start adding value.
While the answers to those questions should help companies determine if RBM is right for them and how to go about achieving their goals, the size of their firm is generally not a consideration. Hall believes RBM is just as applicable to a single study company as it is to Merck or Pfizer. Anyone who wants to improve their quality oversight and be more proactive and informed in their trial decision making is a candidate for RBM.
“RBM simply allows you to get an aggregate view of what is happening on a study, across all the sites, in almost real time,” notes Hall. “This then allows you to make informed decisions about how to monitor the study. That’s really the essence of RBM. With a traditional model you visit every site on a regular basis and perform routine tasks, hoping to pick up on any issues that might exist. With a risk-based model you’re identifying where you think issues might exist, understanding them, determining the underlying cause, and then doing something about it with more insight than has ever been possible before. Then you can look to see if that issue is occurring at other sites as well. A company with multiple studies can get some additional economies, but the concepts remain the same.”
Although a company can implement RBM at almost any time, Hall notes the earlier you start it, the more apt you are to get value from it, as the more chance you have of correcting issues early in the trial. That said, we are seeing some companies getting value from jumping into studies which are already some way through patient treatment. When doing so, sponsors will already have a good idea which sites present the most risk, and so by looking at the historic data using an RBM tool, companies are able to get validation of what they think they already know and potentially move forward with more confidence in the tools and techniques.
Getting Approval Can Still Be A Challenge
The benefits of RBM oftentimes will still not make the sale an easy one. Hall believes the biggest challenge of selling RBM within the company is making the business case for it. Whenever a new technology is in play, company executives want the cost recouped as quickly as possible. Unfortunately, since most companies don’t know what they don’t know, that cost can be difficult to justify.
“If RBM is successful at identifying problem areas, the monitoring cost for a company could actually go up rather than down on some studies,” states Hall. “We have to convince companies that what we are attempting to do is reduce the routine and unnecessary monitoring performed at a site that is doing a great job. But that is something we can’t really identify prior to getting RBM involved in a study. The best way to figure out what you can save is by starting with RBM on a few studies and then trying to scale up. A lot of the value of RBM is in identifying and correcting issues early in a trial, which may not be directly attributable to savings in monitoring costs, but can be significant in terms of reducing findings during inspections, and ultimately achieving a smoother path to regulatory approval..”
Pharma is a conservative industry, and being a closely regulated industry, there will always be resistance to change. Additionally, if a company has been doing something the same way for many years, the risk of changing that approach may seem quite high. Executives may need to see many case studies to be convinced that this is the right solution for their companies and is worth taking the risk.
“RBM will offer companies visibility of their data, give them views they have never had before, and will allow them to make decisions they have never been able to make before, much earlier in the trial. It’s hard for them to say no to that, since every company running clinical trials would like better visibility of their data. Some companies will need to see more evidence, so I expect it may still take a little more time for RBM to really become accepted as a standard business practice across the industry, but we’re seeing momentum build on an almost daily basis right now and we’re very excited about the opportunity RBM offers the industry.”