Table 1 Evaluation Criteria for Sources of Clinical Assay Performance Data
From: Considerations in the development of circulating tumor cell technology for clinical use
Qualitative Rankings of Data Sources and Study Designs | |
|---|---|
Most Reliable | Collaborative studies that use large panels of well characterized samples; summary data from well-designed external proficiency testing schemes; inter-laboratory comparison programs |
Reliable | Other data from proficiency testing schemes, well-designed peer-reviewed studies, and expert panel-reviewed FDA summaries |
Less Reliable | Less well designed peer-reviewed studies |
Least Reliable | Unpublished and/or non-peer reviewed research; clinical laboratory, or manufacturer data; studies on performance of the same basic methodology, but used to test for a different target |
Criteria for Assessing the Internal Validity of the Studies Used to Obtain Data | |
• Adequate descriptions of the assay platform and test procedures, including the reproducibility of test results, quality control measures, and comparison to a “gold standard” reference assay. | |
• Samples representative of the study population, blinded testing and interpretation. | |
• Data analysis including point estimates of sensitivity and specificity with 95% confidence intervals, and sample size/power calculations. | |
• Studies graded as convincing, adequate, or inadequate based on their ability to provide confident estimates of analytic sensitivity and specificity using intended sample types from representative populations. | |