Validation of new cancer biomarkers: a position statement from the European group on tumor markers
Biomarkers are playing increasingly important roles in the detection and management of patients with cancer. Despite an enormous number of publications on cancer biomarkers, few of these biomarkers are in widespread clinical use. In this review, we discuss the key steps in advancing a newly discover...
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| Veröffentlicht in: | Clinical chemistry (Baltimore, Md.) Md.), 2015-06, Vol.61 (6), p.809-820 |
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| container_title | Clinical chemistry (Baltimore, Md.) |
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| creator | Duffy, Michael J Sturgeon, Catharine M Sölétormos, György Barak, Vivian Molina, Rafael Hayes, Daniel F Diamandis, Eleftherios P Bossuyt, Patrick M M |
| description | Biomarkers are playing increasingly important roles in the detection and management of patients with cancer. Despite an enormous number of publications on cancer biomarkers, few of these biomarkers are in widespread clinical use.
In this review, we discuss the key steps in advancing a newly discovered cancer candidate biomarker from pilot studies to clinical application. Four main steps are necessary for a biomarker to reach the clinic: analytical validation of the biomarker assay, clinical validation of the biomarker test, demonstration of clinical value from performance of the biomarker test, and regulatory approval. In addition to these 4 steps, all biomarker studies should be reported in a detailed and transparent manner, using previously published checklists and guidelines. Finally, all biomarker studies relating to demonstration of clinical value should be registered before initiation of the study.
Application of the methodology outlined above should result in a more efficient and effective approach to the development of cancer biomarkers as well as the reporting of cancer biomarker studies. With rigorous application, all stakeholders, and especially patients, would be expected to benefit. |
| doi_str_mv | 10.1373/clinchem.2015.239863 |
| format | Article |
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In this review, we discuss the key steps in advancing a newly discovered cancer candidate biomarker from pilot studies to clinical application. Four main steps are necessary for a biomarker to reach the clinic: analytical validation of the biomarker assay, clinical validation of the biomarker test, demonstration of clinical value from performance of the biomarker test, and regulatory approval. In addition to these 4 steps, all biomarker studies should be reported in a detailed and transparent manner, using previously published checklists and guidelines. Finally, all biomarker studies relating to demonstration of clinical value should be registered before initiation of the study.
Application of the methodology outlined above should result in a more efficient and effective approach to the development of cancer biomarkers as well as the reporting of cancer biomarker studies. With rigorous application, all stakeholders, and especially patients, would be expected to benefit.</description><identifier>ISSN: 0009-9147</identifier><identifier>EISSN: 1530-8561</identifier><identifier>DOI: 10.1373/clinchem.2015.239863</identifier><identifier>PMID: 25882892</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Anticoagulants ; Biomarkers ; Biomarkers, Tumor - analysis ; Cancer ; Cancer therapies ; Clinical Chemistry Tests ; Disease ; Europe ; Health Care Sector ; Humans ; Inventors ; Laboratories ; Medical research ; Neoplasms - diagnosis ; Pilot Projects ; Plasma ; Proteins ; Regulatory approval ; Reproducibility of Results ; Specimen Handling - methods ; Studies</subject><ispartof>Clinical chemistry (Baltimore, Md.), 2015-06, Vol.61 (6), p.809-820</ispartof><rights>2015 American Association for Clinical Chemistry.</rights><rights>Copyright American Association for Clinical Chemistry Jun 2015</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c447t-47652180a21417acab508a6389c914acbea5d639c4ea07af2707fb89145503613</citedby><cites>FETCH-LOGICAL-c447t-47652180a21417acab508a6389c914acbea5d639c4ea07af2707fb89145503613</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25882892$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Duffy, Michael J</creatorcontrib><creatorcontrib>Sturgeon, Catharine M</creatorcontrib><creatorcontrib>Sölétormos, György</creatorcontrib><creatorcontrib>Barak, Vivian</creatorcontrib><creatorcontrib>Molina, Rafael</creatorcontrib><creatorcontrib>Hayes, Daniel F</creatorcontrib><creatorcontrib>Diamandis, Eleftherios P</creatorcontrib><creatorcontrib>Bossuyt, Patrick M M</creatorcontrib><title>Validation of new cancer biomarkers: a position statement from the European group on tumor markers</title><title>Clinical chemistry (Baltimore, Md.)</title><addtitle>Clin Chem</addtitle><description>Biomarkers are playing increasingly important roles in the detection and management of patients with cancer. Despite an enormous number of publications on cancer biomarkers, few of these biomarkers are in widespread clinical use.
In this review, we discuss the key steps in advancing a newly discovered cancer candidate biomarker from pilot studies to clinical application. Four main steps are necessary for a biomarker to reach the clinic: analytical validation of the biomarker assay, clinical validation of the biomarker test, demonstration of clinical value from performance of the biomarker test, and regulatory approval. In addition to these 4 steps, all biomarker studies should be reported in a detailed and transparent manner, using previously published checklists and guidelines. Finally, all biomarker studies relating to demonstration of clinical value should be registered before initiation of the study.
Application of the methodology outlined above should result in a more efficient and effective approach to the development of cancer biomarkers as well as the reporting of cancer biomarker studies. 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Academic</collection><jtitle>Clinical chemistry (Baltimore, Md.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Duffy, Michael J</au><au>Sturgeon, Catharine M</au><au>Sölétormos, György</au><au>Barak, Vivian</au><au>Molina, Rafael</au><au>Hayes, Daniel F</au><au>Diamandis, Eleftherios P</au><au>Bossuyt, Patrick M M</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Validation of new cancer biomarkers: a position statement from the European group on tumor markers</atitle><jtitle>Clinical chemistry (Baltimore, Md.)</jtitle><addtitle>Clin Chem</addtitle><date>2015-06</date><risdate>2015</risdate><volume>61</volume><issue>6</issue><spage>809</spage><epage>820</epage><pages>809-820</pages><issn>0009-9147</issn><eissn>1530-8561</eissn><abstract>Biomarkers are playing increasingly important roles in the detection and management of patients with cancer. Despite an enormous number of publications on cancer biomarkers, few of these biomarkers are in widespread clinical use.
In this review, we discuss the key steps in advancing a newly discovered cancer candidate biomarker from pilot studies to clinical application. Four main steps are necessary for a biomarker to reach the clinic: analytical validation of the biomarker assay, clinical validation of the biomarker test, demonstration of clinical value from performance of the biomarker test, and regulatory approval. In addition to these 4 steps, all biomarker studies should be reported in a detailed and transparent manner, using previously published checklists and guidelines. Finally, all biomarker studies relating to demonstration of clinical value should be registered before initiation of the study.
Application of the methodology outlined above should result in a more efficient and effective approach to the development of cancer biomarkers as well as the reporting of cancer biomarker studies. With rigorous application, all stakeholders, and especially patients, would be expected to benefit.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>25882892</pmid><doi>10.1373/clinchem.2015.239863</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Clinical chemistry (Baltimore, Md.), 2015-06, Vol.61 (6), p.809-820 |
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| source | Oxford University Press Journals All Titles (1996-Current); MEDLINE |
| subjects | Anticoagulants Biomarkers Biomarkers, Tumor - analysis Cancer Cancer therapies Clinical Chemistry Tests Disease Europe Health Care Sector Humans Inventors Laboratories Medical research Neoplasms - diagnosis Pilot Projects Plasma Proteins Regulatory approval Reproducibility of Results Specimen Handling - methods Studies |
| title | Validation of new cancer biomarkers: a position statement from the European group on tumor markers |
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