Guest Column | October 10, 2017

7 Reasons You're Not Ready For Risk Based Monitoring

By Kunal Sampat, Senior Manager, Clinical Research, Abbott Vascular

7 Reasons You're Not Ready For Risk Based Monitoring

You recently attended a clinical research conference, webinar, or sales pitch on risk based monitoring (RBM). Or your clinical team is putting together a strategy for a new trial and wants to implement RBM. Everyone you talk to is raving about efficiencies, cost savings, and how it’s the future of clinical research. Or maybe people are telling you how hard it is to implement RBM.

Before you make a go/no-go decision, it would help to spend time assessing whether or not your organization is ready for RBM.

RBM isn’t for the faint of heart, especially if you belong to a clinical organization of more than 10 or so individuals. Just like anything else, RBM comes with its own set of challenges and opportunities.

In this article, I’ll share seven reasons that indicate your organization may not be ready for risk based monitoring.

The inspiration for this article came from a risk based monitoring event I attended earlier this year. The event was led by Collaborations in Clinical Research. The panel included three experts: Candace Elek, ClinPros; Jim Hart, Hart Clinical Consultants; and Lorne Cheeseman, Kestrel Biologic, and it was moderated by Carey Smoak, DataCeutics.

So, let’s get into the reasons why you might not be ready for risk based monitoring.

1. You are too busy to define critical variables up front

The panel members discussed how RBM begins with the protocol. The protocol is the guiding document that defines the objectives of the trial, the key inclusion and exclusion criteria, and the schedule of events. The information in the protocol ultimately forms the basis of the case report forms and the critical variables.

During the protocol development stage, it is important to keep the goal of the trial front and center. You want to question the need for every piece of information you plan to collect and whether this information supports the ultimate trial objective. If it doesn’t support the trial objective, the requirement should not be added to the protocol.

This is easier said than done. One way to define critical variables is to have a cross-functional discussion among your medical science, clinical operations, biostatistics, clinical safety, and data management team members. Have an honest conversation of how the addition of a given data point is going to help you accomplish the trial objective.

Critical variable discussions can last several hours. At a minimum, you want to dedicate two full days to discussing and defining critical variables. If you and your entire team don’t have time to do this work, you’re not ready for RBM.

2. Your trial size is too small

If your trial sample size is too small, say less than 100 patients at five to eight clinical sites, you really won’t benefit from risk based monitoring. You might as well stick to the traditional approach of monitoring 100 percent of your clinical trial data.

The time and energy you’ll put into developing a risk based monitoring plan might complicate things for you and your team. Instead, you want to focus on optimizing your protocol and focusing on the data that will help you with your product or indication approval.

3. Your trial design is too complex

If your trial has multiple sub-group populations and each sub-group in and of itself is a mini-trial whose outcome is important to your organization, you may want to skip RBM completely.

The definition of complex will vary from trial to trial, but the question you must ask yourself is, “For my trial design, what’s the worst-case scenario if I implemented RBM?” If the outcome from the worst-case scenario is sufficient for you to prove the safety and effectiveness of your medical product and you can measure cost savings and efficiencies as a result of RBM, then you should proceed with implementation.

4. Your functional managers are hesitant to change

Clinical research is a made up of multidisciplinary team members, each with their own focus. The scientist cares about collecting more data and high-quality data. The operations lead cares about how easy (or difficult) it is to collect the data. The statistician cares about how easy it is to analyze the data and the accuracy of the data. The question then becomes, “Can RBM satisfy the needs of each of these stakeholders? If so, how?”

If the different functional team members are not aligned on the benefits of risk based monitoring, you won’t make a dent when it comes to implementation.

The best way to get team buy-in is to identify the benefits to every stakeholder involved, including your clinical trial sites. RBM needs to make everyone’s life easier (not more difficult).

5. You plan to swap risk based monitoring with remote monitoring

The main premise of RBM is monitoring critical data while managing risk. You’re basically trying to move away from 100 percent monitoring.

If your RBM plan states that you’ll perform fewer in-person monitoring visits based on certain events, such as enrollment at the site, number of protocol deviations, etc., that’s great. However, some sponsors or CROs that are skeptical about RBM decide to perform additional remote monitoring.

Remote monitoring can be a burden for sites, as it requires monitors to have a focused call with the research coordinator. In the traditional form of in-person monitoring, research coordinators don’t always need to be present when the monitor is reviewing the data. However with remote monitoring, we’re demanding more focused attention and time from the research coordinator, which comes at an additional cost (or frustration for the site).

If you’re planning to implement RBM, trust the process and the plan, and don’t add remote monitoring to compensate for any perceived RBM shortcomings.

6. You want to implement risk based monitoring because the agency said so

There is no regulatory requirement to implement RBM on your clinical trial. Given the high cost of clinical trials, regulatory agencies such as the FDA have been open to a risk-based approach to clinical monitoring.

It is up to you and your organization whether to implement RBM on your trials. This may be a no-brainer for many of you reading this article. But given that a large percentage of companies may be small organizations with limited resources, it’s important to remind ourselves that RBM is not a regulatory requirement.

7. You cannot decide who should own risk based monitoring at your organization

I’m of the belief that the RBM champion can vary from one organization to another. In some companies, RBM is led by data management. In other companies, this process is owned and managed by clinical project management or clinical operations.

Whatever the case may be, you want to assign the development and implementation of RBM to anyone who is passionate about bringing about change in the way you’ve traditionally performed clinical monitoring. It’s not worth fighting over which functional group should own RBM.

Organizations spend countless hours planning for RBM, but when it comes to implementation, they revert to 100 percent monitoring or a closer variation of it. Thus, having a champion who is willing to execute on the RBM vision is a blessing for any organization.

Is RBM right for you?

RBM is not for every company. There are many factors, such as devoting time to identify critical variables, size and complexity of the trial, stakeholder buy-in, understanding of regulatory requirements, and ownership of the RBM process, that determine whether an organization is ready for RBM.

What risk based monitoring challenges are you trying to tackle? Leave them in the comments section below.

About The Author:

Kunal is a senior manager of clinical research at Abbott Vascular and also the founder of the Clinical Trial Podcast, a podcast and blog platform for clinical research professionals. His goal is to help you accelerate your clinical research career and be a more effective leader. He enjoys connecting with like-minded people, introducing new ideas, and immersing himself in an environment of continuous learning. You can find him on LinkedIn.