Background

A Korean Biotech company had designed a protocol that focused on the treatment of myopia. The trial was a double-blind phase 2, recruiting 450 patients across 10 sites. The measure of disease progression (or lack off) required a lot of tests at site to make sure it was assessed accurately.

The trial team were particularly concerned by the sites’ adherence with those stringent tests: if sites were not compliant with the protocol design, they would not be able to determine treatment efficacy.

The sponsor turned towards CRScube to implement cubeCDMS and cubeRBQM, aiming to achieve the right level of monitoring granularity.

As the trial progressed, the monitoring team identified areas of concerns related to the recording of adverse events (AE). They noticed discrepancies in reporting rates, differences in data quality, and site-specific issues, making it difficult to maintain consistent safety standards across recruiting sites.

Solution: cubeRBQM

The client leveraged the following features of cubeRBQM:

Adverse events analysis

cubeRBQM allowed the clinical operations team to monitor adverse event trends by site effortlessly. The system helped them focus on the number of AE incidences, incidence rate and frequency of occurrence between treatment groups. The dashboards were customizable, enabling the team to filter data by specific criteria such as patient demographics.

The visual representation of data, including heatmaps and trend graphs, made it easy to identify sites with unusually high or low AE rates. This allowed the team to quickly focus on sites that required further investigation.

Data points granularity

The monitoring team particularly appreciated the ability to drill down into specific assessments in cubeRBQM, allowing them to identify discrepancies between sites around assessment practices. They were able to identify data trends and use it to focus their monitoring efforts on sites that required additional training to improve data quality.

The system also flagged sites with inconsistent data entry patterns, such as missing or delayed tests and AE reports. These discrepancies were brought to the attention of site monitors, who could then follow up with site personnel to emphasize the importance of accurate and timely data reporting

Direct navigation from cubeRBQM to cubeCDMS

One of the standout features of cubeRBQM was its seamless integration with the EDC system cubeCDMS. When a potential issue was identified in the cubeRBQM dashboard, users could navigate directly to the relevant subject-specific data in cubeCDMS with a single click.

This integration significantly reduced the time and effort required to verify data and resolve issues. Monitors could easily cross-check AE data against source documents, ensuring that any discrepancies were resolved promptly and accurately.

The ability to drill down from site-level summaries to individual patient records without leaving the cubeRBQM interface improved efficiency and reduced the risk of errors associated with switching between systems.

Outcome

The implementation of cubeRBQM in this ophthalmology trial resulted in several positive outcomes:

The use of cubeRBQM in this phase 2 ophthalmology clinical trial demonstrated the system’s effectiveness in enhancing risk-based monitoring processes. By providing real-time insights into adverse event trends, identifying discrepancies between sites, and enabling seamless navigation to subject-specific data in cubeCDMS, cubeRBQM played a crucial role in ensuring the success of the trial.

This case study highlights the importance of adopting advanced RBM systems like cubeRBQM to manage complex clinical trials efficiently and effectively.