Despite significant investments in basic science by the US National Institutes of
Health, there is a concern that the return on this investment has been limited in
terms of clinical utility. In the field of biomarkers, translational research is used
to bridge the gap between the results of basic research that identify biomolecules
involved in or the consequence of carcinogenesis and their incorporation into medical
application. The cultural separation between different scientific disciplines often
makes it difficult to establish the multidisciplinary and multi-skilled teams that
are necessary for successful translational research. The field of biomarker research
requires extensive interactions between academic researchers and industrial developers,
and clinicians are needed to help shape the research direction that can be addressed
only by a multidisciplinary, multi-institutional approach. In this article, we provide
our perspective on the relatively slow pace of cancer biomarker translation, especially
those for early detection and screening.
Abbreviations:
AFP (alpha-fetoprotein), BDL (Biomarker Developmental Laboratory), BRL (Biomarker Reference Laboratory), CVC (Clinical Validation Center), DMCC (Data Management and Coordinating Center), EDRN (Early Detection Research Network), FDA (Food and Drug Administration), NCI (National Cancer Institute), NIH (National Institutes of Health), PPV (positive predictive value), PSA (prostate-specific antigen)To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Translational ResearchAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Biomarkers and surrogate endpoints: preferred definitions and conceptual framework.Clin Pharmacol Ther. 2001; 69: 89-95
- Cancer biomarkers: can we turn recent failures into success?.Natl Cancer Inst. 2010; 102: 1462-1467
- A framework for evaluating biomarkers for early detection: validation of biomarker panels for ovarian cancer.Cancer Prev Res. 2011; 4: 375-383
- Why have protein biomarkers not reached the clinic?.Genome Med. 2011; 3: 66-67
- Phases of biomarker development for early detection of cancer.J Natl Cancer Inst. 2001; 93: 1054-1061
- Translational Research Working Group developmental pathway for biospecimen-based assessment modalities.Clin Cancer Res. 2008; 14: 5672-5677
- Evaluating markers for the early detection of cancer: overview of study designs and methods.Clin Trials. 2006; 3: 43-56
- How to improve reliability and efficiency of research about molecular markers: roles of phases, guidelines, and study design.J Clin Epidemiol. 2007; 60: 1205-1219
- Biomarkers for cancer risk, early detection, and prognosis: the validation conundrum.Cancer Epidemiol Biomarkers Prev. 2007; 16: 1918-1920
- Improving the biomarker pipeline to develop and evaluate cancer screening tests.J Natl Cancer Inst. 2009; 101: 1116-1119
- Molecular markers for early detection.Semin Oncol. 2010; 37: 224-242
- Sources of bias in specimens for research about molecular markers for cancer.J Clin Oncol. 2010; 28: 698-704
- Biospecimen Reporting for Improved Study Quality (BRISQ).J Proteome Res. 2011; 10: 3429-3438
- Reporting recommendations for tumor marker prognostic studies (REMARK).J Natl Cancer Inst. 2005; 97: 1180-1184
- Pivotal evaluation of the accuracy of a biomarker used for classification or prediction: standards for study design.J Natl Cancer Inst. 2008; 100: 1432-1438
- Alpha-fetoprotein, des-gamma carboxyprothrombin, and lectin-bound alpha-fetoprotein in early hepatocellular carcinoma.Gastroenterology. 2009; 37: 110-118
- Ovarian cancer biomarker performance in prostate, lung, colorectal, and ovarian cancer screening trial specimens.Cancer Prev Res. 2011; 4: 365-374
- The road from discovery to clinical diagnostics: lessons learned from the first FDA-cleared in vitro diagnostic multivariate index assay of proteomic biomarkers.Cancer Epidemiol Biomarkers Prev. 2010; 9: 2995-2999
Article info
Publication history
Published online: February 10, 2012
Accepted:
January 13,
2012
Received in revised form:
January 9,
2012
Received:
December 4,
2011
Identification
Copyright
Published by Elsevier Inc.
