As any drug developer knows, clinical trials generate a lot of raw and electronic data from multiple sources. Yet tracking progress and reviewing results from each separate database can be cumbersome in traditional environments. This "rear-view" mirror approach to monitoring doesn't support preventative planning to mitigate future risks and can account for 20-30% of a trial's costs.
Recognizing the opportunity increase efficiency and deliver information faster, Covance created Xcellerate® Monitoring, a platform that integrates clinical trial data to help sponsors proactively decrease the inherent risks associated with clinical trials.
At a recent clinical seminar in China, Dimitris Agrafiotis, PhD, Vice President, Chief Data Officer discussed how Xcellerate Monitoring tracks quality, patient safety and protocol compliance in clinical trials.
"Many sponsors, both in and outside of China, don't have access to near real-time data," said Agrafiotis. "They rely on a lot of reports and jump from tool to tool to get the job done. With Xcellerate Monitoring, we offer a very inviting user experience that supports embedded workflows so users can gain insights from analytic visualizations and take action."
By looking at data both individually and collectively, Agrafiotis showed the audience in China how sponsors could better monitor risk areas by looking at both individual and collective data from operational, medical and statistical contexts.
"Pre-programmed error checks allow data managers to discern missing, erroneous or inconsistent data," said Agrafiotis, "while risk monitoring allows clinical trial managers to assess and mitigate operational risks, such as issues with patient screening, enrollment or drop-out as well as protocol deviation or audit findings."
From the medical perspective, physicians can view up-to-date results to better assess patient safety and other clinical issues that could compromise a trial's integrity. Statisticians are also involved by checking for non-random anomalies in the data that could highlight issues with equipment, processes or quality.
Working with Xcellerate Monitoring is more than just running a platform. It involves building quality into the process itself. "We start with quality by design to engineer in quality and design out risk in the study," explained Agrafiotis.
This process involves calculating risk levels at the study, site and operational level, considering the complexity of the study and reviewing previous site quality and prior performance. By evaluating risk in this phase, a sponsor's strategy is better informed to determine the amount and frequency of source data verification (SDV) and source data review (SDR) required during the study.
Through a combination of remote and on-site monitoring, issues are identified and critical data processes are highlighted based on the levels of observed risk. "This allows central monitoring staff to efficiently direct site monitors to the right locations with the most optimal frequency to assure patient safety and data quality with greater speed and efficiency," said Agrafiotis. Along with alerts and embedded notifications, sponsors are empowered to recognize issues and take action, faster.
With faster interventions and more intelligent monitoring, sponsors can expect several gains in quality and cost saving. In a recent study, Covance observed:
These promising metrics show both the quality and the value that Xcellerate Monitoring can bring to any study by leveraging clinical trial data. As the technology continues to make a difference in trials, China and the rest of the global market can expect to make more data-driven decisions when monitoring and managing risk.
Whether running a trial with Covance or another provider, Xcellerate Monitoring SaaS (software as a service) is available to sponsors in and outside of China or can be run or as part of larger set of solutions with the Xcellerate Clinical Trial Optimization® suite. Learn more.