The Early Detection Research Network: 10-Year Outlook

Abstract

BACKGROUND The National Cancer Institute's Early Detection Research Network (EDRN) has made significant progress in developing an organized effort for discovering and validating biomarkers, building resources to support this effort, demonstrating the capabilities of several genomic and proteomic platforms, identifying candidate biomarkers, and undertaking multicenter validation studies. In its first 10 years, the EDRN went from a groundbreaking concept to an operational success. CONTENTS The EDRN has established clear milestones for reaching a decision of “go” or “no go” during the biomarker development process. Milestones are established on the basis of statistical criteria, performance characteristics of biomarkers, and anticipated clinical use. More than 300 biomarkers have been stopped from further development. To date, the EDRN has prioritized more than 300 biomarkers and has completed more than 10 validation studies. The US Food and Drug Administration has now cleared 5 biomarkers for various clinical endpoints. SUMMARY The EDRN today combines numerous collaborative and multidisciplinary investigator-initiated projects with a strong national administrative and data infrastructure. The EDRN has created a rigorous peer-review system that ensures that preliminary data—analytical, clinical, and quantitative—are of excellent quality. The process begins with an internal review with clinical, biostatistical, and analytical expertise. The project then receives external peer review and, finally, National Cancer Institute program staff review, resulting in an exceptionally robust and high-quality validation trial.

Developments in the Identification of Glycan Biomarkers for the Detection of Cancer

“…Furthermore, in most cases, no cut-off values were determined that would be used in later validation studies. In order to further evaluate the potential of glycan-based biomarkers for the detection of cancer, such studies, as well as further validation studies assessing the specificity and sensitivity in less well-defined datasets, will have to be performed according to study design strategies proposed by the National Institutes of Health Early Detection Research Network (68). …”

Glycans and Cancer

“…Several attempts have been conducted to detect specific glycosylation changes in glycoproteins for the early diagnosis of cancer patients. So far, only one antibody has been approved by FDA for the early detection of a cancer biomarker (Srivastava, 2013).…”

Therapeutic target database update 2014: a resource for targeted therapeutics

“…First, we added information and search tools based on the ICD codes (22,23) for searching the targets, biomarkers, drugs and other TTD data related to various disease conditions. For more extensive coverage of potential biomarkers and for enabling their convenient access by the ICD codes, we added a significantly higher number (1755) of literature-reported biomarkers for more variety of disease conditions (365) than those in the existing biomarker databases that primarily focus on molecular biomarkers of specific disease classes (17,19) or clinically prioritized sets (18). We also added information and enabled the search of TTD data via drug scaffold names (227 scaffolds for 736 drugs and leads) for facilitating the search of the drugs, targets and diseases related to specific molecular scaffolds.…”