Risk Based Monitoring: A more strategic approach to site monitoring and clinical data management

February 3, 2016

By Kristie Lively, VP of Clinical Operations & Quality Compliance, eclipse
When executed properly, a Risk Based Monitoring approach to clinical trial monitoring helps sponsors allocate resources more effectively, saving money and time and improving data quality. Here’s a closer look at the practice, its future and what it could mean for the industry.
The cost of running an effective clinical trial continues to rise. Trials have grown increasingly complex, causing new challenges for sponsors and CROS in clinical trial oversight. Companies are searching for ways to drive efficiency, improve data quality, lower costs and cut timelines. Site management and monitoring are cited as two of the most costly components of clinical trials. Risk Based Monitoring (RBM) can be a more strategic approach to site monitoring and clinical data management – one that aims to allocate resources based on risk and need, as opposed to delegating resources equally, regardless of the unique demands and challenges of each site and team, while still maintaining robust data oversight.
Industry groups like TransCelerate and regulatory agencies around the world are all advocating for more efficiency-driving tactics like RBM. Thus, more sponsors are considering adopting the approach—although there is still quite a way to go before it is a universally accepted practice. RBM is a paradigm shift challenging the traditional model of clinical data monitoring, and it’s still in its foundational phase. But we believe its adoption will continue to increase as more research and case studies are completed and best practices are standardized and improved.
Risk Based Monitoring: How it works
Risk Based Monitoring refers to a variety of tactics, from limited source verification to remote monitoring or centralized monitoring, aimed at strategically using resources to ensure the safety of patients and the integrity of data. In fact, sponsors may have even used some of these methods before when looking at trial but not actually called it RBM. One example of this is the limited monitoring that can occur on Investigator Initiated Trials.
There are many benefits cited from those organizations utilizing RBM.
These include:
• Superior data quality
• Lower costs
• Fewer errors across full study data upon review
• More efficient delegation of resources
• Increased safety

To determine if RBM could work for you, consider these steps:

1. Engage all requisite departments and work together to create a monitoring and data management plan that defines and manages risks to clinical conduct and data quality.
2. Read fully the FDA’s comprehensive guidance on implementing the approach.
3. Study factors such as complexity of study design, safety of product and study population.
RBM should only be considered when the risks applicable to your study are well defined. Take time to assess the protocol for all risks: scientific, medical, regulatory and/or operational.

Choosing a partner – Consideration for Risk Based Management Adoption
Many companies partner with a CRO or clinical technology vendor to help develop the plans and manage the process, technology and data management solutions. When choosing a partner, ask yourself the following questions:
1. Is the EDC database system flexible enough to allow for changes throughout the study? (RBM is a flexible approach, so you’ll need a flexible system.)
2. Does the system provide real-time information on how sites are performing? Are you satisfied with the quality of data?
3. How well does the data and the system integrate with existing technologies you’re using?
4. Would your staff be comfortable using this system? Is the interface intuitive and simple?
5. What are your reporting needs in terms of type and frequency?
An effective RBM solution will be simple to use, offer superior data management capabilities and seamlessly integrate with your existing technologies all while providing needed information on-demand to make decisions.
If you do opt for a Risk Based Monitoring approach, consider building in additional modes of site communication to compensate for sites who may feel less supported (as dictated by their level of risk and need determined in your monitoring plan). You still may need to visit all sites in-person; it’s just a matter of determining the frequency with which you need to be performing these visits.
Although more people are beginning to discuss, and even implement, RBM, there is still some uncertainty surrounding the best way to proceed. Risk Based Monitoring’s aim is to free up resources so your study team will have more time to focus on data integrity, adhering to protocol and keeping patients safe. When conducted responsibility, in partnership with relevant technology solutions, it can promote better decision making, improved efficiency, shorter timelines and lower costs. It will take time and research before it is more broadly adopted, but you can be certain the industry will continue to study its effectiveness and develop best practices that will likely improve the approach even further.

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