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Benefits of centralized monitoring in clinical trials

Benefits of centralized monitoring in clinical trials

With the SCOPE Summit for clinical operations executives approaching in Orlando, Florida, the industry is gearing up for a variety of engaging discussions, presentations and events. A key element of this conference is the risk-based monitoring (RBM) track, where speakers help address how this evolving discipline is revolutionizing our industry. As a panel participant and speaker in this track, Nicole Stansbury, executive director, adaptive and intelligent monitoring, clinical development services, provides a preview of the key topics she will address at SCOPE.

Centralized monitoring in clinical trials is growing increasingly popular in the industry, what separates PPD’s strategy apart from others?

PPD’s centralized monitoring solution is cross-functional and uses enhancements in existing systems and processes, as opposed to expensive investments in new technologies that don’t connect with the systems our teams use daily. Our RBM approach blends on-site and centralized monitoring, integrating seamlessly into the core of our monitoring through people, process and technology. This integration helps quality without reducing costs.

How has recent regulatory guidance shaped this strategy?

PPD has been developing our RBM strategy since 2008.  Recent regulatory guidance provided by International Council on Harmonization (ICH), specifically ICH E6 R2, confirmed PPD’s approach was aligned with regulatory expectations. As a result, PPD could formalize our process into three core standard operating procedures (SOPs) that govern our RBM strategy. These SOPs were supplemented by new elements developed specifically to address components of ICH E6 R2, including a centralized monitoring plan template and reporting of centralized monitoring finding trends in a monthly status report to our clients.

What role are clinical research associates playing in this industry shift?

PPD believes clinical research associates (CRAs) play a critical role in this shift. Their focus changes from being a primary party responsible for finding issues in the data and identification of protocol deviations to relying on centralized monitoring to find and identify those issues. By relying on centralized monitoring to find these issues, CRAs roles evolve to being able to specifically target these anomalies during on-site and remote interim monitoring visits (IMVs). CRAs can investigate the root cause of those anomalies and work with the sites on process improvement.

What are the benefits of centralized monitoring?

Centralized monitoring helps to distinguish reliable data from unreliable data:

  • Rapid review of data within hours or days of entry into electronic data capture (EDC) to identify anomalies and/or protocol deviations. This rapid review allows for prompt intervention with sites to prevent reoccurrence or repeated errors across patients. PPD has seen a 22 percent decrease in the time to review baseline data, compared to traditionally monitored trials, and 17 percent better detection of significant deviations.
  • Identification of trends across subjects, sites, countries, regions, protocols or programs that cannot be identified by CRAs who look at small pieces of data across a sampling of sites and subjects even if performing 100 percent source data review (SDR) and source data verification (SDV).
  • Increase cost-effectiveness by reducing the extent and/or frequency of on-site IMVs. PPD has been able to reduce on-site IMVs by over 20 percent, in some studies. This reduction has provided clients between a 12 to 25 percent reduction in clinical monitoring costs and a six to 15 percent total cost savings. 

These benefits are just the beginning and are expected to improve as our clients increase their confidence in RBM and become more willing to adopt RBM in totality.

Nicole Stansbury is an executive director, adaptive and intelligent monitoring, clinical development services.

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