“There are always a million reasons not to do something”
A great inspiring quote from Jan on an episode of The Office when Pam was making excuses not to go to Art school. A very recognisable habit, isn’t it? Talking ourselves out of doing something or coming up with excuses to not make positive changes in our lives.
We like to get comfortable in our routines. Yes, we stretch, we grow, but at a pace that feels well, convenient – because we’re in control. Thriving when we’re out of control is a much tougher prospect; it takes us out of our sweet spot.
The other day I came across a publication “7 reasons you’re not ready for Risk-based Monitoring”. I was thinking to myself why would you not be ready? In my mind you are more than ready when your protocols continue to grow, your study flow charts are overflowing, and you keep on collecting and monitoring extraneous data “just in case”. Does this ring any bells to you?
As an industry that wants to reduce risks to a minimum, many of us tend to copy and paste the “old” protocols, for the sake of ease. It takes a bit of guts and experiment to embrace transformation by defining risky areas and thresholds, and describing your tolerance levels towards them from the beginning.
In the end implementing RBM is nothing more than executing a well-defined shift in the way things work. An exciting journey of transformation that will allow your organisation to stay competitive and continue to grow.
Ready for it? No excuses please.
Excuse number 1: “We are too busy to define critical variables up front”
The idea is to not re-create critical variables on a per study base, but be smarter than that. Knowing that about 80% of the risks fall into the same categories, i.e. demographics, vital signs, lab data, medical history, concomitant medication, end-of-study data and adverse events, most of these variables need to be defined only once. Subsequently they can be re-used within and across projects.
Besides critical variables RBM is also about management of critical processes, such as subject enrolment, and risk mitigation actions. All RBM aspects, once identified and defined during the protocol development stage of a project or therapeutic area, can be re-utilized on a study by study basis. Avoiding redundant study team revisions of the same processes over and over again.
Excuse number 2: “Our trial size is too small”
Ask yourself how many studies you run in parallel and with how many subjects? If you look at the bigger picture than just zooming in on one study, you most likely count more than 100 patients. RBM is a cost-effective approach for the largest chunk of the pharma and biotech studies, i.e. phase 2 and 3 clinical trials, and proven to be successful in phase 4 trials.
Excuse number 3: “Our trial design is too complex”
Over the years, being overly cautious has become common practice for pharma and biotech companies. As a result, this led to a “more is more” mindset. Today, both the FDA and new GCP protocol invite sponsors to think more critically. They encourage the industry to move away from complexity such as conducting sub-studies within one study, and act according to what is really important to patient safety and study endpoints. Risk-based Monitoring fundamentally contributes to leaning out the clinical trial process with a “less is more” focus in mind.
Excuse number 4: “Our functional managers are hesitant to change”
All the regulatory evidence is there to support why implementing RBM shouldn’t be a point of concern. However, the first step in any change process is acknowledging and understanding the need for change. Making the unknown known will trigger the onset of change. RBM solution providers can help organisations draw up how RBM is going to affect the organisation, i.e. a stakeholder analysis highlighting the improvements that ripple through the future of an organisation. After all, Risk-based Monitoring is supposed to make everyone’s life easier.
Excuse number 5: “We plan to swap Risk-based Monitoring with remote monitoring”
First, we need to understand that sites remain key when it comes to executing clinical trials. RBM allows remote monitoring on an as needed basis and checking much of what needs to be checked off-site. This way of working enables the CRA to focus on people rather than data during on-site visits. Instead of keeping head down in paperwork, the CRA can spend more time working with the site team to uncover the root-cause of problems, helping, consulting, and inspiring. Risk-based Monitoring is a complementary activity that supports the remote monitor to focus on different aspects than the on-site monitor avoiding duplicating the effort.
Excuse number 6: “It is not a regulatory requirement to implement RBM”
Obviously RBM is not developed for the sake of pleasing any regulatory body. The biggest driving factors behind implementing Risk-based Monitoring of clinical trials are quality and savings. Centralised monitoring of trial sites based on risk profile is cheaper, less resource-intensive and, ultimately, more efficient. But consider this: trials that are using RBM have found that it increases the effectiveness of quality control as well as data accuracy. What is in your way of bringing your drugs to market faster, better and safer even if it is just suggested by regulatory bodies?
Excuse number 7: “We cannot decide who should own Risk-based Monitoring at our organisation”
“Who is going to manage the implementation of RBM?” It’s a question that will shape clinical trial decisions for the next decade. The benefits of Risk-based Monitoring have opened-up a myriad of opportunities for pharma companies, but they have also sparked the need for organisational changes. Pharma companies must increasingly ask themselves if they want to spend their time looking for the hard to find experts to manage their clinical trials, or if they want to partner with an RBM solution provider. So, in case your organisation cannot make up its mind, consult an RBM solution provider.