Case Study

Large PMA Study Of CRC Diagnostic

Source: Health Decisions Inc.
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This PMA study was being done to determine sensitivity and specificity using colonoscopy as the reference method, with lesions confirmed as malignant by histopathologic examination, quantitative molecular assays for KRAS mutations, aberrant NDRG4 and BMP3 methylation, and β-actin, plus a hemoglobin immunoassay. They were facing many challenges including ensuring that complex sample-management requirements were met; improving patient compliance with study obligations; monitoring data quality, including critical data on cancer staging; and ensuring adequate sample count and efficient sample collection with attention to distribution by age cohort. Continue reading to see what strategies for risk management and mitigation were among those that Health Decisions utilized in this study.