Risk Based Monitoring: A Popular Option for Clinical Trials on the Rise!

During the process of drug development, clinical trials can be significantly expensive. There are several studies that require multiple monitoring and visits across several sites. While conventional monitoring techniques are responsible for major costs, the additional travel costs are often expensive. Remote monitoring, however, offers a better and less expensive choice.

Moving away from the conventional approach and frequent on-site visits, risk based monitoring(RBM) offers a hassle-free way to perform clinical trials. It offers 100 percent source data verification, or SDV, towards a lot of activities combined together, which includes centralized data collection as well as data monitoring.

Difference between Traditional Monitoring and RBM

Traditional monitoring is different from risk based monitoring in its approach and goal. Whereas the goal of traditional monitoring in clinical trials is to ensure quality of data and safety of patients, a well designed RBM strategy can support and even enhance the practice while also using resources efficiently.

Risk based monitoring mainly aims to allocate all the resourced depending on risk factors. Likewise, there are targeted monitoring strategies and source data verification strategies, which can be used alternatively.

Although frequent onsite monitoring combined with 100% SDV is not recommended for monitoring trials, many organizations are still hesitant to shift to RBM from conventional methods. According to the FDA, any approach that emphasizes on the risks of specific clinical trials are more likely to ensure safety of patients than regular visits and even 100% SDV. In fact, it is an inefficient approach to handle every single risk in the same manner. Risks of all kinds should be handled as per priority and managed correctly. Monitoring, after all, has large effect on the clinical trial and it’sbottom-line.

Rise of Risk Based Management

With a strong theoretical base and sound marketing strategies, RBM is now on the rise. However, there are oppositions and fears with respect to the future of RBM.

Applied Clinical Trials published an article recently, which shows the rise of RBM worldwide and its popularity. The study revealed that in 2009, less than 33% respondents in Clinical Trials Transformation Initiative (CTTI) survey have used centralized data monitoring to target, guide, or even replace onsite visits.

Likewise, it was also reported that 50% were already using RBM strategy across programs or on pilot basis with the support of centralized data analytics.

Basically, three primary reasons were deduced for adopting RBM:

1. To reduce monitoring costs by up to 78%
2. Improve overall data quality by up to 66%
3. Improve overall quality oversight by up to 66%

Implementing Risk Based Monitoring

Indeed, it is challenging to implement RBM, though not impossible. In order to achieve success, it is very important to consider a few things:

• During RBM, experts should identify the greatest risk factors based on past experiences with similar trials and develop metrics that can quantify potential risk factors
• Staffs should be assigned specific roles together with written operational instructions for betterment
• Planning decision trees for unforeseen consequences like failures
• Defining relationships between data
• Creating a plan to monitor and coordinate all activities within a team
• Implementing RBM strategies through training

The Way to Success

For a successful RBM plan, communication pathways should be strong among team members, and every single team member should have clear and concise understanding of their roles and responsibilities. Information should be specific to study and processes should be well developed for gathering, analyzing and acting on data throughout the clinical trial. Additionally, if you want to include electronic data collection techniques as a part of the clinical monitoring plan, you should have proper technological capabilities for capturing, monitoring, and transferring data.

The Future

Risk based monitoring is the only solution to rising costs of clinical research. By deploying 100% SDV, it is possible to shift costs, limit budget and resources, and ensure quality of data. While it is challenging to move towards an alternative approach, the future of RBM still looks bright.

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