Key risk indicators
Key Risk Indicators to Reduce Your Clinical Trial Costs and Timelines
Defining Key Risk Indicators (KRI’s) helps the sponsor and the CRO to reduce clinical trial costs and timelines, and establishes relevant quantitative thresholds for Risk-Based Monitoring.
Key Risk Indicators, or KRIs, predefined by the sponsor, are a summary of results that potentially reveal, amongst other things, protocol deviations in the clinical trial conduct across certain investigational sites. Predefined metrics are computed for each site. On-site monitoring frequency can be adapted based on site performance.
Thanks to our strong statistical know-how, IDDI is well positioned to determine statistically-driven KRIs for your clinical trials. IDDI delivers statistical quality control for your trial based on proven programs which will assess the study-specific KRIs.
KRIs can be defined for different areas:
- Study conduct: accrual rate, screening success, protocol deviations, drop-outs;
- Safety: adverse event (AE) rates, serious adverse event (SAE) rates;
- Treatment compliance: dose reduction, dose delays;
- Clinical data management: overdue forms, query rates.
IDDI has developed specific programs to calculate and extract the KRIs in a specific format that allows pooling of KRIs issued by the sponsor.
IDDI provides the reporting of the KRIs:
• Summary tables
The analyses based on Key Risk Indicators and other automated statistical analyses of the data can be produced at predefined frequencies.
Example of KRI:
Scatter plot of AE rate. Each dot corresponds to a site. Sites that are inside the red windows have the KRI signal ‘ON’ for low reporting of adverse events.