An Alternative to Risk-Based Monitoring May Prove to be Beneficial


Applied Clinical Trials

That's because the discussion shifted away from one focused on changing monitoring methods and doing reduced source document verification (SDV) to 'intelligent monitoring.'

When I speak on the topic of risk-based monitoring (RBM) at industry events, someone invariably comes up afterward to say how nice it is we finally stopped talking about risk-based monitoring!

That's because the discussion shifted away from one focused on changing monitoring methods and doing reduced source document verification (SDV) to 'intelligent monitoring.' This is a term that describes a unique approach to RBM used by our Compass team. It's a concept that resonates strongly with clinical trial professionals as noted in an earlier Trial Blazer blog.

Let's take a closer look at what I mean by intelligent monitoring and why it's smarter than risk-based monitoring alone.

Monitor What Matters

There are thousands of data points in a trial. Are you focusing on the right ones, or will you be in for a surprise when your trial ends?

Sad but true, pouring over audit inspections and findings has become a hobby of mine. In 15+ years of managing clinical trials and monitoring teams, I've been able to narrow in on what regulators care about most in determining trial performance. My research shows regulatory bodies prioritize five key areas when they review clinical trials:

  • Patient Safety

  • Regulatory Compliance

  • Data Quality

  • Site Engagement

  • Protocol Integrity

The challenge then becomes: How do you get an accurate view of performance across all of these areas? I've seen first-hand too many examples where over-reliance on clinical data falls short. Even today when RBM is taking a foothold, many sponsors' strategies include objective clinical trial data as their sole source to inform them on trial performance.

While clinical trial data can indeed give some insight into safety and data quality, clinical trial data alone may miss certain issues. This is especially true with key indicators of site performance such as regulatory compliance and site engagement. All too often trial teams are caught off-guard by a site monitor's findings − when in fact − the issues could have been predicted using the right data analytics!

Intelligent monitoring is specifically designed to account for those five factors the FDA is looking at most closely. A combination of three sources of data is required to get a complete picture of site performance: operational metrics, clinical outcomes, and qualitative feedback from the sites.

Keeping the Monitor in Risk-Based Monitoring

Relying on statistical analysis (e.g.; data anomalies, outliers, etc.) is not enough as shown by numerous examples of informed consent fraud, patient screening issues, absent Investigators, and other difficult-to-catch issues. What commonly ends such a problem is the "gut" feeling of an experienced monitor. His or her eagle-eye and perspective sharpened on hundreds of sites, is capable of seeing poor quality or misleading data that can be traced back to poor site engagement and site performance in the study.

Because the input of skilled site monitors is so invaluable, their qualitative feedback continues to be an important part of monitoring. These clinical trial professionals capture the softer site performance measures surrounding investigator engagement, staff knowledge, site resources, patient recruitment efforts, and other areas.

Regular feedback from site monitors is essential and can be a key component of analytics used by trial managers to predict performance issues. Likewise, well-planned feedback gathered from site staff can provide valuable data to complete the site performance picture.

View Meaningful Performance

Rather than zeroing in on a singular data point in time, intelligent monitoring looks at data in new and meaningful ways. This smarter approach lets sponsors know how a trial is performing over the short-, mid- and long-range.

  • Short-term – You have the assurance of knowing what is happening at sites, whether physically located there or off-site.

  • Mid-term −You are able to pinpoint exactly where a site performance problem is. This enables an emerging trend to be identified and addressed before it becomes a long-term performance issue.

  • Long-term – You are able to understand how sites are performing relative to one another over the course of the study.

Equipped with this intelligence in a digestible format, sponsors are able to consistently take the right action. Monitoring this way can go a long way to assure regulators you are in control of your trial and those five critical areas (Patient Safety; Regulatory Compliance; Data Quality; Site Engagement; and Protocol Integrity).

Intelligent monitoring also establishes consistency among site monitors and helps ensure that any compliance and performance issues are handled the right way. These are just a few of the ways intelligent monitoring helps sponsors improve quality management in clinical trials.

While a technology-enabling tool like Compass can speed RBM implementation and help with adjusting monitoring, more importantly, such a tool enables decisions for management of a clinical trial in the most intelligent and quality way possible. With these benefits, more and more people are gravitating toward the intelligent monitoring concept.




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