The early detection research network: 10-year outlook.

Area of Science:

• Biomarker Discovery and Validation
• Cancer Research
• Genomics and Proteomics

Background:

• The National Cancer Institute's Early Detection Research Network (EDRN) has significantly progressed in biomarker discovery and validation.
• Established over 10 years, EDRN evolved from concept to operational success, building crucial resources and demonstrating platform capabilities.

Purpose of the Study:

• To outline the EDRN's structured approach to biomarker development and validation.
• To highlight the network's achievements in identifying and validating cancer biomarkers.

Main Methods:

• Established clear "go" or "no go" milestones based on statistical criteria and clinical utility.
• Prioritized over 300 candidate biomarkers and completed more than 10 validation studies.
• Implemented a rigorous peer-review system involving internal, external, and NCI staff review.

Main Results:

• More than 300 biomarkers were stopped from further development through stringent evaluation.
• Successfully prioritized over 300 biomarkers for further investigation.
• Achieved US Food and Drug Administration clearance for 5 biomarkers for clinical endpoints.

Conclusions:

• The EDRN integrates multidisciplinary projects with robust national infrastructure.
• A rigorous peer-review process ensures high-quality analytical, clinical, and quantitative data.
• The EDRN provides a validated pathway for biomarker development, resulting in high-quality trials.