Risk-Based Monitoring is becoming somewhat of a standard in the clinical trials industry as Sponsors look to increase efficiency and cut costs. The ICH GCP E6 guidelines recently put the (R2) addendum into effect which looks to “provide increased clarity and encourge implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting”.
Therefore, a need has developed among Sponsors for a cost-effective methdology for implementing a risk-bsaed approach to study monitoring that uses structured data review processes for maintaining and improving the integrity of trial data.
Centralized Statistical Intelligence was developed to enhance RBM activities and centralize QC of data from all trial sites, flagging those that need investigation.
CSI is an important analytical and business tool for facilitating RBM.
CSI Analytical Model
- Analysis of actual clinical data; all patient-related variables and endpoints
- Compares distribution of all variables in each site with other sites
- Identifies issues such as lack of variability
- Detects data fraud or unusual data patterns
- Assigns a “risk score” to each site using Principal Component Analysis
- Relies on calculated assumptions rather than subjective thresholds
- Drill-down and export data and graphs
- Accessible in real-time, anywhere
CSI Business Model
- Facilitates decision-making on whether a site visit should happen
- Helps monitors limit visits
- Avoids issues that put a trial or regulatory submission at risk
- Facilitate cost savings through reduced monitoring, cleaner data, reduced study duration
Centralized Statistical Intelligence is part of CROScheck™ – a clinical analytics platform for Risk-Based Monitoring.