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



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