The NextGen CRA
December 2nd, 2015
By Bruno Gagnon, Faculty Member of SF State University and Nadia Bracken, Founder of the ClinOps Toolkit
NextGen CRAs utilize relevant metrics for early issue identification
Meet a new breed of site monitors: the Next Generation (NextGen) CRAs. These creative thinkers question everything to increase the probability of a successful trial. They embrace the use of Study Quality Metrics as a strategic tool for clinical trial oversight. NextGen CRAs are agile in centralized monitoring, coolly managing daily priorities, and proactively mitigate risk.
The monitoring challenge: Too many unexpected surprises at the sites
This case study illustrates a NextGen clinical operations team overcoming significant challenges during a complex clinical trial of infectious disease. The sponsor used a full-service Clinical Research Organization (CRO) and allocated only three in-house CRAs to provide CRO oversight and project management for 120 global trial sites.
At the onset, the trial faced multiple challenges including limited resources, competing priorities, and confusion of roles between the CRO and the Sponsor. Further, the team encountered protocol deviation levels as high as 25%.
At the start of the study, the CRO sent periodic monitoring and site performance reports to the in-house CRAs. The reports indicated that sites were missing critical patient screening procedures, lab results were invalid due to poor quality samples, and some sites had even missed their IRB submission deadlines. The in-house CRAs were relying on the CRO to notify them when an issue arose as opposed to planning and preventing issues from occurring.
80% reactive to 80% proactive: Optimizing issue management
Alongside the Clinical Operations management team, the CRAs and Clinical Trial Managers reviewed the obstacles they faced and took a step back to “look at the big picture”. This led to piloting a Continuous Quality Management solution on a handful of studies. The goal was to shift from 8 daily hours of reactive work and firefighting to an effective daily plan and proactive review for indicators of poor study site performance.
Adopting a real-time awareness of new issues as they occur through centralized monitoring
Traditionally, the CRAs had been very reactive to EDC data. The sites with the highest number of outstanding queries received the most attention. However, there was a delay between the time the query data was analyzed in spreadsheets and when it was resolved. Initially, our CRAs would attempt to solve an issue based on dated reports and find it had already been resolved; an inefficient use of resources.
Once the Continuous Quality Management solution was in place, the NextGen CRAs were able to access meaningful visualizations of their data to inform decision making. One of the CRA’s most useful charts illustrated queries and enrolled subjects. Query rates were normalized by number of subjects. Sites with high query rates were easily identifiable as those falling above the regression line. The CRAs and CRO partners were alerted to troubling trends that quickly escalated. Sites registering above the regression lines could be prioritized and contacted first.
The CRO and the study coordinator would meet regularly to determine the cause of high query levels and decide on the best way to address the underlying issues. This proactive approach enabled by analytics and visualization tools avoided tens, if not hundreds of queries over the course of the study.
Manage daily priorities
At the beginning of the study the CRAs spent an equal amount of time monitoring sites and dealing with each issue as it arose. The shift to proactively managing tasks, meant that CRAs were freed from constantly triaging their inbox and had a great ability to plan activities on a daily and weekly basis. By implementing a Continuous Quality dashboard, the NextGen CRAs were less reliant on incoming emails to manage their daily activities. Instead, they were able to assign and manage tasks using the cloud based software solution to plan ahead of time.
Adopting a cloud based Continuous Quality Management solution changed the process of identifying, managing and responding to site issues. Due to an increased site performance visibility, CRAs realized that each site did not need equal monitoring. Instead, they adapted their strategy focusing on the 20% of problematic sites with the highest number of unresolved queries. They were able to focus their monitoring visits on these sites and direct additional support from the CRO there when needed.
The NextGen CRAs could refer to the heat map below to understand the time taken by the sites to resolve issues compared to the study mean. They spent less time worrying about the ‘blue sites’ and focused more of their time on the 20% of problematic red and yellow sites.
Further investigation of high query rates and associated sites revealed common challenges. As an example, translation of patient forms to different languages and regional differences in patient care practices were identified as a common root cause of queries. The NextGen CRAs recommended refining forms and instructions to reduce query rates.
Make smart decisions crazy fast
Through automation and analytics, the CRAs were able to see trends, quickly identify the cause of issues and make informed decisions faster. They mobilized resources to the problematic sites and reduced outstanding queries by more than 50%.
By adopting a continuous proactive review of Quality Metrics as the cornerstone of site management, these NextGen CRAs improved site performance and reduced protocol deviations by 50%. The CRAs were able to take control of their day by focusing on daily priorities and benefit from a more effective risk-management approach to their work.