Table 1 Sub-category of attributes associated with a clinically useful biomarker
Analytical Validity | Clinical Utility |
1) Analytical Modelling 2) Specimen Anatomical or Collection Site 3) Assay Validation/Precision/ Reproducibility/Accuracy 4) Quality Assurance of Reagents 5) Study specifies the assay method used 6) Study states whether Assay is Validated/Standardised/Optimised 7) Bio-specimen Matrix/Type 8) Biospecimen Collection 9) Biospecimen Inclusion/Exclusion Criteria 10) Biospecimen Quality 11) Cell Culture 12) Experimental Animal Details 13) Experimental Procedure Description 14) Mechanism of Stabilization 15) Sample Pre-processing 16) Storage/Shipping Transport 17) Time between Diagnosis and Sampling | 34) Authority/Guideline Approval 35) Decisional Analysis 36) Cost-effectiveness 37) Ethics 38) Feasibility/BM Implementation 39) Funding 40) Harms and Toxicology 41) Invasiveness 42) Human Factor 43) Biomarker Usefulness 44) Study Type |
Clinical Validity | Rationale |
18) Adverse Events 19) Vital state of Biospecimen 20) Analytical Modelling 21) Blinding 22) Experimental Outcomes 23) Intervention 24) Missing Data 25) Methodology Details 26) Patient Eligibility 27) Reported Pre-specified Hypothesis 28) Randomisation 29) Reference Standard 30) Sample size Calculation 31) Sensitivity/ Specificity 32) Statistical Modelling 33) Trial Design Description | 45) Identify the unmet clinical need for specific disease 46) Verify biomarker unmet need - is there an existing solution? 47) Pre-specified hypothesis/Exploratory discovery 48) Unmet need for the specified BM type |