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A targeted approach to medical and safety reviews PhUSE Annual - - PowerPoint PPT Presentation
A targeted approach to medical and safety reviews PhUSE Annual - - PowerPoint PPT Presentation
A targeted approach to medical and safety reviews PhUSE Annual Conference Edinburgh, UK October 9, 2017 Erik Doffagne Product Manager Introduc*on Principles of a stat approach Guiding Safety Review AGENDA Demo Conclusion Introduc*on
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AGENDA
Introduc*on Principles of a stat approach Guiding Safety Review Demo Conclusion
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CluePoints Value Chain
Clinical Data Quality Oversight Risk-Based Monitoring M&A Due Diligence Inspection Readiness The value of CluePoints lies in its ability to identify anomalous data and site
- perational issues enabling pro-active and efficient management in clinical data
quality & patient safety, optimization of on-site monitoring and a significant reduction in overall regulatory submission risk.
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CSM: More than Just Fraud Detection in Clinical Research
- Assessment of Clinical and Operational Data Quality
- Detection of:
- Staff Training issues
- Misunderstanding/complexity of the protocol
- Faulty Measuring Devices
- Sloppiness/Laziness
- Support Monitoring Activities
- Focused SDV (Costs Reduction)
- Data 100% verified through Central Statistical Monitoring (Quality Stamp)
Error Sloppiness Tampering Fraud
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Quality Issue Example: Mis-Calibrated Equipment
Phase 3 Study – Vaccination 200 Sites, 16000 Patients Temperatures for all sites in Spain consistently in a lower range. Investigation revealed mis-calibrated thermometers shipped to all sites in Spain.
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Quality Issue Example: Patient ePRO Diary Fraud
Phase 3 Study – Chronic Disease Site with 15 patients – all ePRO diary entries done by site: Same time of day, same day for all patients. Sponsor removed all 15 patients from analysis.
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AGENDA
Introduc*on Principles of a stat approach Guiding Safety Review Demo Conclusion
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Statistical methods can help to detect areas at risk and improve data quality
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What patterns can be detected?
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What patterns can be detected? Shift in mean
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What patterns can be detected?
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What patterns can be detected? Too similar patients
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What patterns can be detected?
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What patterns can be detected? Carry over visits after visits
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Principles of the approach
- Compare centers against each other centers
- Use statistical models to assess significance
- Automated detection of outliers and atypical patterns
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Overall Data Quality Assessment
- Perform many tests on all variables, regardless of the meaning or
importance of data.
- These scores form a very large matrix with as many rows as
centers and as many columns as individual tests
- Compute a single Data Inconsistency Score for each site
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AGENDA
Introduc*on Principles of a stat approach Guiding Safety Review Demo Conclusion
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Identify patients at risk Center Scoring Center Profile Patient Level Data
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Review patients at risk
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Review patients at risk
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Track signals identified during patient reviews
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AGENDA
Introduc*on Principles of a stat approach Guiding Safety Review Demo Conclusion
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AGENDA
Introduc*on Principles of a stat approach Guiding Safety Review Demo Conclusion
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Conclusion
- The combination of interactive visualization and advanced
statistical methods allows medical reviewers to focus effort where it matters the most.
- Traceability is key to ensure that every action and decision are
documented.
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