Risk-based quality management methodologies address risk control and management during execution of a clinical trial. RBQM adoption has generated valuable benefits for project management and clinical operations, changing the way trial monitoring is done. However, data management activities are ideally suited for an RBQM approach as well. Today, we explore five benefits data managers can gain from implementing a risk-based quality management approach and the enabling applications.
- Enhanced Data Quality
- Streamlined Data Management
- Problem Prevention
- Elimination of Silo Mentality
- Study Risk Control
- Enhanced Data Quality – An RBQM approach starts with risk identification and management activities before a clinical trial goes live. The study team completes a comprehensive risk assessment and categorization using a guided tool to identify significant study risks and to define preventive, mitigating and monitoring measures throughout the life of the study. The data management team participates in the assessment providing input and sharing expertise about data management risks while learning from other functional representatives about other potential study risks. Based on the risk assessment, the team can choose to implement preventive and monitoring measures that ensure quality of critical study data including EDC form design changes, targeted edit checks, vendor management and interim analysis.
- Streamlined Data Management – Applying the RBQM process includes setting up critical data definitions, key risk indicators (KRIs) and key performance indicators (KPIs) for ongoing data surveillance. A comprehensive set of KRIs and performance metrics should include data quality and flow parameters to ensure data collection and quality are continuously monitored and any issues are detected and addressed as soon as possible. Modern RBQM tools like Xcellerate® are web based with automated data flows and visual analytics that eliminate the problems and management overhead associated with Excel trackers. These tools allow data management teams to have a near-real-time view on data collection and quality issues across the entire study, or even portfolio of studies, rather than a single patient form at a time. It also allows the team to focus on critical data, patient safety and data integrity while the non-value-added work of updating trackers and managing spreadsheets goes away.
- Problem Prevention – With the RBQM approach, the data management team establishes and monitors standard and study-specific key performance indicators and critical to quality data to continuously assess study performance on both clinical and operational levels. Using the tracking dashboards such as Xcellerate Data Review, study teams can focus on the few sites causing the most issues as well as analyze which EDC pages generate the most queries. This approach allows the study team to see the source of common issues and take actions to prevent it from becoming a problem. Using RBQM to focus on sites with the largest percentage of queries – and then coaching these sites – can address 80% of study queries, based on our experience. For example, there may be three or four sites with significant open queries; this raises a “red flag” for data management and suggests the need to shift focus to these problem sites to ensure study data quality. Using targeted measures, we can identify the sites with the most queries, highest numbers of queries per subject, or sites with the most aging queries. These all might be signs that a site is struggling. The study team can then coach or retrain the site and avoid further issues. These insights, with the associated risks and resolutions, become “lessons learned” for the next trial.
- Elimination of Silo Mentality – Adopting the RBQM approach facilitates close coordination between clinical operations, data management and other functional groups. The teams work together to assess study risks, define key study performance indicators, and monitor and resolve ongoing issues. Each group holds a different piece of the puzzle for a successful trial execution, and RBQM helps connect the pieces to see the entire picture. It takes the entire study team to ensure that the trial’s database lock is on time or ahead of schedule. With the RBQM approach, all teams get access to a cross-functional risk assessment, leverage each other’s knowledge to ensure data quality, rely on advanced analytics to monitor study performance, and generate actionable insights. The result is better trial outcomes with shorter timelines, increased efficiencies and controlled costs.
- Study Risk Control – The bottom line for clinical teams is risk control and management within clinical trials to deliver desired study outcomes. Proven benefits of RBQM include data-driven study management, increased operational performance, fewer deviations and fewer discontinuations. An added benefit of RBQM is increased transparency of CRO operations and higher confidence for clinical trial sponsors.
RBQM Client Application
A client came to Covance requiring monitoring and fast reporting of specific data types and targeted endpoints for a clinical trial. The protocol included the need for data at the subject level and aggregate level.
Using Xcellerate®, the Covance team defined risk and set the methodology for tracking and reporting key indicators during the trial. The team identified study data, defined how it would be measured, set thresholds, then measured the data on a daily basis and provided details to the sponsor, with nearly real-time access to reports through our portal.
This RBQM approach provided the sponsor with clear, reliable insights and allowed its team to make informed decisions and corrective actions during the trial.
To learn more about how RBQM has proven beneficial to achieving efficiencies in effective quality management, watch the webinar, Measuring Success of a Quality Risk Management Approach.