When it was first talked about, it was as if Risk-Based Quality Management (RBQM) was some kind of magical solution to all your clinical trial problems. Mix in a bit of Risk Assessment, a touch of Risk-Based Monitoring (RBM). throw in a dash of Central Monitoring, say the magic words (RBQM) three times and abracadabra, pull all of the aces out of the hat you'll get huge cost savings, fewer site visits, increased trial efficiency and increased patient safety. What’s not to love?
Spoiler alert - the problem with magic is it’s just an illusion. The real mystery is in how did the magician do it?
Here’s part of the mystery about RBQM. If I take the words risk, based, quality and management individually, I think I have a pretty good understanding of what each separate word means. But when you add the words together in one phrase (risk-based quality management) something magical happens, and not in a good way.
The phrase RBQM means different things to different people in different organizations depending on who they are, their job role, their organization, their organizations business model and appetite for risk, and a whole host of external factors over which they have little or no control, including what their customers, suppliers and regulatory authorities think.
And the regulatory authorities are part of the reason there’s mystery in RBQM. That’s because regulatory authorities issue guidance and not instruction manuals. They tell you what to do, but not how to do it.
That’s not a criticism. They can’t possibly legislate for every circumstance or variation. They need to focus on getting the correct outcomes for the industry. It therefore has to be the responsibility of individual organizations to understand, interpret, implement and comply with the guidance. Importantly, they also need to be able to demonstrate that compliance. And that’s often not easy to do for reasons we’ll come on to.
But before we do, earlier this year the Association of Clinical Research Organizations (ACRO) report “Risk-Based Monitoring in Clinical Trials: Past, Present and Future” highlighted the slow take-up of RBQM in pre-pandemic clinical trials. In a survey of over 6,500 trials in 2019, only 33% were conducting Risk Assessments and 19% had implemented Central Monitoring.
Obviously, that survey was pre-pandemic, and clearly the pandemic had a huge impact on all clinical trials. We ran a less formal survey last month of over 60 organizations to check whether their post-pandemic numbers were different. Over 90% said they were doing Risk Assessments and over 60% said they had implemented Central Monitoring. That’s a big increase in both since the pandemic, which is what we probably would all have expected, right? But is still begs the question “Why isn’t it 100% given E6(R2) was adopted in 2016?”
The fact is that while implementing RBQM might sound simple, it’s far from easy. That’s because implementing a risk-based approach affects every part of your business. From your standard operating procedures to staff selection and training; from your business model to the way you capture and record information; right the way through to the way you interact with customers, sites, delivery partners and patients. And of course, every organization is unique, with different people, cultures, behaviors, and attitudes.
So while it’s not easy, I wanted to share our top 3 tips for successful RBQM implementation based on having done it with dozens of organizations, from global sponsors and CROs, right the way down to small niche players.
The first is tip is to implement an RBQM Change Program. Last year in the ICH E6(R3) Executive Working Committee presentation, they were very clear that Change Management is the greatest challenge in successfully implementing RBQM. And while change is a challenge, but it’s not impossible. The key to success is having the right change program structure. And while there are any number of different models you could use, the most important thing to take away from this post is that the UNLEARNING process is as important as the change process. Getting people to stop doing what they’ve done for the last 20 years is extremely difficult, but absolutely necessary.
The second tip is structure your data. If you want to successfully implement RBQM then you need to get the data right, and ideally before you start. What we’re finding is that even within companies, every clinical trial has a different data structure. That creates a real problem for both risk management and central monitoring because if you want to be able to identify trends, compare different trials within a site, or different sites across trials, you must have the same data definitions. And the volume of data is increasing exponentially because of the rise of Decentralized Clinical Trials (DCTs) and the arrival of new technologies, such as AI and always-on wearables. There’s also the challenge of interoperability and accessing data from aging legacy systems to take into account.
The third key to success is making someone explicitly responsible for RBQM. Don’t make it part of their responsibility, mixed in with other roles. It needs to be all about RBQM – it’s that important to the future success of your organization. So important that it needs to be signaled and signposted. RBQM needs to be in the person’s job title. And it needs to be a senior position – some with the clout, enthusiasm, and communication skills to make things happen. For them to be successful you must also give them resources. They can’t do it on their own. And because what gets measured gets done, include RBQM related deliverables in their job description. Things like “Implement Risk Assessment on every clinical trial”; “Implement Central Monitoring on all Phase II. III and IV trials by March” and “Ensure everyone in the organisation is trained in Risk Management and Good Clinical Practice”. And if you really want to make things happen, make RBQM part
of people’s performance related pay!
So, while RBQM can appear to some like a magic trick, once you take out the mystery and apply some rigor, structure and common sense, you will be successful. I don't think I need to worry about the Magic Circle throwing me out for revealing trade secrets, do you? :-)