Table 2.
Issue | Potential hazards | Solutions |
---|---|---|
| ||
Test performance for early-stage HCC detection | • Inferior sensitivity to imaging-based screening | • Non-inferiority design with acceptable margin • Pragmatic trial design to incorporate the impact of adherence |
False positive management | • Lack of care pathways for false positives results • Implications of a false positive result on future cancer risk |
• Longitudinal trial design to understand and delineate the optimal care pathway for false positives and the associated future cancer risk |
Costs | • Lack of payor coverage • Low HCC incidence will result in high numbers needed to screen for cancer detection |
• Rational price setting based on cost-effectiveness analyses with contemporary inputs • Calibrate intensity of screening based on patient risk |
Blood processing | • For central processing, errors in local blood collection and shipping • Lack of standardisation of results across centres for markers that are processed onsite |
• Quality control for central shipping of blood samples with adequate site training • Calibration of local labs to ensure consistency of results across centres |
Test reporting | • Linkage of test result back to ordering provider/patient • Providing a dichotomous or continuous test result |
• Develop reporting pathways for test results • Providing continuous test results depending on assay characteristics with interpretation (positive/negative) |
HCC, hepatocellular carcinoma.