CHALLENGE:
To monitor the safety of a new CAR-T treatment, specifically the incidence and grade of CRS – a serious side effect of treatment – in a hematologic malignancies trial.
SOLUTION:
Real-world data, coupled with deep and innovative analysis using Phesi’s Trial Accelerator™ platform, was used to improve decision making and ensure patient safety throughout the trial.
- Phesi created a digital patient profile to establish baseline characteristics.
- 5,335 patients from 63 cohorts matched the characteristics and treatment profile.
- 650 patients were identified as having complete grade detail related to CRS toxicity.
- Phesi used patient-centric data to construct a digital twin to monitor CRS toxicity.
- Phesi analysis determined CRS toxicity of the CAR-T treatment did not increase the safety risk for patients and instead was trending towards lower NCI toxicity grades.
THE DATA:
IMPACT:
Phesi’s approach supported internal decision making and was used to guide discussions on reducing patient and investigator site burden, cost and trial duration.
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