Featured case studies
Background
A top 10 Korean pharma company initiated a global, multi-centre, double-blind, phase 3 clinical trial in hypertension. Their goal was to test the safety and efficacy of a new treatment to control blood pressure in patients who did not respond to existing therapies.
The study targeted the recruitment of over 800 patients across 60 sites. Given the complexity of managing patient enrolment and ensuring data quality across diverse regions, the trial team decided to implement cubeRBQM to streamline operations and enhance data oversight.
The trial’s global scope presented several challenges:
Enrolment tracking
Monitoring patient enrolment at the study, country, and site levels in real-time was critical to keep track of recruitment targets. The study team needed to ensure that the study population reflected the intended demographic distribution.
Data quality & integrity
The nature of the trial required meticulous attention to data integrity, as well as quality and timeliness of data capture. These parameters were identified as high-risk areas for the monitoring team.
Protocol compliance
Ensuring that enrolment into the trial was following protocol design, particularly in stratifying patients by demographic characteristics such as age, gender, and race, was paramount to the trial's success.
Solution: cubeRBQM
cubeRBQM was integrated into the trial’s operational framework to address these challenges.
The tool provided the following key functionalities:
Real-time enrolment tracking
cubeRBQM enabled the trial team to monitor enrolment status in real-time at the study, country, and site levels. This allowed for immediate identification of any discrepancies or delays in patient recruitment.
Risk-based monitoring
The tool's risk-based approach allowed the monitoring team to focus resources on sites with higher risks of non-compliance or data quality issues, optimizing monitoring efforts and reducing overall costs.
Stratification & demographics analysis
cubeRBQM provided advanced analytics to track demographic data by stratum, ensuring balanced representation of patient populations across different regions and sites.
Results
The implementation of cubeRBQM had several significant benefits:
Efficient resource allocation
By focusing monitoring efforts on high-risk sites identified through cubeRBQM, the trial team was able to allocate resources more efficiently. This led to a reduction in monitoring costs while maintaining data quality and regulatory compliance.
Improved data quality
The continuous monitoring of enrolment and demographic data with cubeRBQM ensured that data integrity was maintained throughout the trial. This was particularly important in a double-blind study, where any discrepancies could compromise the study’s validity.
Protocol compliance
During the enrolment phase, cubeRBQM was used to identify any imbalance in demographic data by stratum. Early identification of any underrepresentation of certain demographic groups by region was key to adapt recruitment strategies.
The real-time insights provided by cubeRBQM enabled the trial team to make informed decisions quickly. This agility was crucial in addressing potential issues before they could impact the trial’s outcomes.
Additional benefit
The data management team appreciated how easy and quick it was to setup cubeRBQM. The views, configured directly from the protocol, matched what the team needed to see. The configuration was seamless and done much faster than with other tools.
This top 10 Korean pharma reduced its monitoring costs through risk-based monitoring, while maintaining data quality and regulatory compliance.