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Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease
TABLE 4-1 Brief Summary of the Results of the Case Studies
Biomarker
Analytical Validity
Qualification
Utilization: Possible Uses
Utilization: Surrogate Endpoint Use
Tumor Size
No
Numerous trials exist with inconsistent findings on tumor shrinkage and clinical benefit
Data needed to improve analytical validity of one or more test
Current data do not support use as a surrogate endpoint
CRP
High-sensitivity tests available
RCTs and observational studies available; limited data on CRP’s biological role in disease progression
Risk prediction; potential expansion of statin treatment to specific populations
Current data does not support use as a surrogate endpoint
Troponin
Validated tests are available for many uses. More sensitive tests are also being developed
Extensive data for acute troponin, limited data on chronic troponin; data collection is ongoing
Safety uses
Current data does not support use as a surrogate endpoint
