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ENSURING RISK-BASED MONITORING SUCCESS – KEEP IT SIMPLE!

Posted by Roberta Alexander, Ph.D. on May 28, 2015 5:22:00 PM

San Diego Clinical Research Network (SDCRN) organized another great event on May 21, 2015 to address Risk Based Monitoring (RBM) in clinical trials. This event was co-organized with OmniComm, an Electronic Data Capture and eClinical Solutions company, and ResearchPoint Global, a full-service CRO with 22 global offices and clinical coverage in more than 60 countries.

The event was also hosted by OmniComm and ResearchPoint Global, and was held on the patio of Wine Steals Seaside Grotto in Cardiff-by-the-Sea. Delicious pizza, trays of cold cuts and cheese, and wine made the event especially enjoyable!

Mark Rice from OmniComm introduced the speakers for the evening: Steve Young, Director of Transformation Services at OmniComm, and Becky Carpenter, Vice President of Operations at ResearchPoint Global (RPG). Teresa also spoke about the activities of SDCRN, including the launch of a weekly newsletter and of the SDCRN website (SDCRN.net). She also announced a new event on personalized medicine planned for early July 2015; stay tuned!

Risk-based monitoring means that the sponsor of a trial targets its monitoring activities and focuses on those activities that are going to deliver the greatest benefit to the study. The sponsor analyzes the risks in terms of sites and data, and decides where monitoring efforts would be best used. RBM is a formal system to establish how the sponsor is going to monitor a study: put more effort where the risk is higher, and put less effort where there aren’t significant risks. Less complex studies, or sites that are performing well, or less critical data, may require less monitoring than complex studies with new technologies, or sites that have a low enrollment rate and are not performing well, or data that is critical for the success of the study. RBM is putting your efforts where they are needed the most.

Steve Young from OmniComm has been a proponent of RBM for many years, and pointed out in his talk that RBM is gaining more and more support by sponsors as well as regulatory agencies. TransCelerate, the non-profit formed by leading pharmaceutical companies to improve efficiency in drug development, is in favor of RBM, and issued a position paper in 2013 indicating that source data verification (SDV) has a small impact on data quality. In addition, both the FDA and the European Medicines Agency (EMA) have issued guidances which portray RBM as a monitoring system superior to traditional SDV monitoring.

SDV requires lots of resources and high costs, with little return on investment. Steve presented figures showing that most data is actually entered correctly by the site staff, and only a small percentage is corrected after it is entered… so why check all data, if the vast majority is just fine? RBM leads to a reduction of SDV and to a more targeted SDV, by focusing on the most critical data. Thus, RBM drives resource efficiency, improves quality, and reduces costs, compared to SDV.

Implementation of an RBM system should be kept simple: assess the key operational risks of your protocol and make a plan to reduce the risks, with the goal to detect and address problems early on. Companies like OmniComm and ResearchPoint Global can provide consulting services to help sponsors implement an RBM system that is simple and efficient.

Becky Carpenter from ResearchPoint Global stated that they prefer to use the term “targeted monitoring” instead of “risk based monitoring.” However, she too stressed the efficiency and cost savings of RBM. Becky presented some case studies, and introduced RPG’s tool, called statistical tool for optimizing risk management (STORM), to aid RBM. She also stressed the importance of site performance assessment (SPA) as part of RBM. How are the different sites performing from month to month? How is the enrollment rate in each of them?

After the initial period, is there a site that stands out from the average of the other sites? Why? That site may need more monitoring, more training, and overall more attention than the other sites that are closer to the average. SPA, which can be done remotely and relatively inexpensively, can identify issues early in the trial and direct resources where they are more needed.

The event on May 21st was another successful get together organized by SDCRN, in partnership with OmniComm and ResearchPoint Global, and the whole clinical research community in San Diego looks forward to the next!

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Tags: Risk-Based Monitoring