1. 2. Id.
2. 11. “Clinical Laboratory Improvement Amendments (CLIA),” Centers for Medicare & Medicaid Services (CMS), available at (last visited July 22, 2019).
3. 5. “Biomarkers Consortium — Workshop: Defining an Evidentiary Criteria Framework for Surrogate Endpoint Qualification,” Foundation for the National Institutes of Health, available at (last visited July 22, 2019).
4. Challenges and Opportunities for Biomarker Validation
5. Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK)