Adding Rigor to Biomarker Evaluations - EDRN Experience.

The cancer early detection biomarker field was, compared to the therapeutic arena, in its infancy when the Early Detection Research Network (EDRN) was initiated in 2000. The EDRN has played a crucial role in changing the culture and the ways people do biomarker studies.The EDRN proposed biomarker developmental guidelines and biomarker pivotal trial study design standards, created biomarker reference sets and functioned as a unbiased broker for the field, implemented the most rigorous blinding policy in biomarker field, developed an array of statistical and computational tools for early detection biomarker evaluations, and developed a multi-disciplinary team-science approach. We reviewed these contributions made by the EDRN and their impacts in bringing the field to more maturity. Challenges and opportunities on the future of cancer early detection biomarker translational research are discussed, particularly in strengthening biomarker discovery pipeline and conducting more efficient biomarker validation studies. EDRN9s approach and success changed how the biomarker field does biomarker studies.