2.00
Hdl Handle:
http://hdl.handle.net/10541/55039
Title:
Biomarker method validation in anticancer drug development.
Authors:
Cummings, Jeffrey; Ward, Timothy H; Greystoke, Alastair; Ranson, Malcolm R; Dive, Caroline ( 0000-0002-1726-8850 )
Abstract:
Over recent years the role of biomarkers in anticancer drug development has expanded across a spectrum of applications ranging from research tool during early discovery to surrogate endpoint in the clinic. However, in Europe when biomarker measurements are performed on samples collected from subjects entered into clinical trials of new investigational agents, laboratories conducting these analyses become subject to the Clinical Trials Regulations. While these regulations are not specific in their requirements of research laboratories, quality assurance and in particular assay validation are essential. This review, therefore, focuses on a discussion of current thinking in biomarker assay validation. Five categories define the majority of biomarker assays from 'absolute quantitation' to 'categorical'. Validation must therefore take account of both the position of the biomarker in the spectrum towards clinical end point and the level of quantitation inherent in the methodology. Biomarker assay validation should be performed ideally in stages on 'a fit for purpose' basis avoiding unnecessarily dogmatic adherence to rigid guidelines but with careful monitoring of progress at the end of each stage. These principles are illustrated with two specific examples: (a) absolute quantitation of protein biomarkers by mass spectrometry and (b) the M30 and M65 ELISA assays as surrogate end points of cell death.
Affiliation:
Clinical and Experimental Pharmacology, Paterson Institute for Cancer Research, University of Manchester, Manchester, UK. jcummings@picr.man.ac.uk
Citation:
Biomarker method validation in anticancer drug development. 2008, 153 (4):646-56 Br. J. Pharmacol.
Journal:
British Journal of Pharmacology
Issue Date:
Feb-2008
URI:
http://hdl.handle.net/10541/55039
DOI:
10.1038/sj.bjp.0707441
PubMed ID:
17876307
Type:
Article
Language:
en
ISSN:
0007-1188
Appears in Collections:
All Paterson Institute for Cancer Research; Clinical and Experimental Pharmacology Group; Medical Oncology

Full metadata record

DC FieldValue Language
dc.contributor.authorCummings, Jeffrey-
dc.contributor.authorWard, Timothy H-
dc.contributor.authorGreystoke, Alastair-
dc.contributor.authorRanson, Malcolm R-
dc.contributor.authorDive, Caroline-
dc.date.accessioned2009-03-12T17:16:37Z-
dc.date.available2009-03-12T17:16:37Z-
dc.date.issued2008-02-
dc.identifier.citationBiomarker method validation in anticancer drug development. 2008, 153 (4):646-56 Br. J. Pharmacol.en
dc.identifier.issn0007-1188-
dc.identifier.pmid17876307-
dc.identifier.doi10.1038/sj.bjp.0707441-
dc.identifier.urihttp://hdl.handle.net/10541/55039-
dc.description.abstractOver recent years the role of biomarkers in anticancer drug development has expanded across a spectrum of applications ranging from research tool during early discovery to surrogate endpoint in the clinic. However, in Europe when biomarker measurements are performed on samples collected from subjects entered into clinical trials of new investigational agents, laboratories conducting these analyses become subject to the Clinical Trials Regulations. While these regulations are not specific in their requirements of research laboratories, quality assurance and in particular assay validation are essential. This review, therefore, focuses on a discussion of current thinking in biomarker assay validation. Five categories define the majority of biomarker assays from 'absolute quantitation' to 'categorical'. Validation must therefore take account of both the position of the biomarker in the spectrum towards clinical end point and the level of quantitation inherent in the methodology. Biomarker assay validation should be performed ideally in stages on 'a fit for purpose' basis avoiding unnecessarily dogmatic adherence to rigid guidelines but with careful monitoring of progress at the end of each stage. These principles are illustrated with two specific examples: (a) absolute quantitation of protein biomarkers by mass spectrometry and (b) the M30 and M65 ELISA assays as surrogate end points of cell death.en
dc.language.isoenen
dc.subjectMethod Validationen
dc.subjectAnticancer Drugsen
dc.subjectMass Spectrometryen
dc.subject.meshAnimals-
dc.subject.meshAntineoplastic Agents-
dc.subject.meshBiomarkers, Pharmacological-
dc.subject.meshCell Death-
dc.subject.meshClinical Trials as Topic-
dc.subject.meshDrug Evaluation, Preclinical-
dc.subject.meshEnzyme-Linked Immunosorbent Assay-
dc.subject.meshGuideline Adherence-
dc.subject.meshGuidelines as Topic-
dc.subject.meshHumans-
dc.subject.meshKeratin-18-
dc.subject.meshLaboratories-
dc.subject.meshMass Spectrometry-
dc.subject.meshProteins-
dc.subject.meshQuality Control-
dc.subject.meshReproducibility of Results-
dc.subject.meshTerminology as Topic-
dc.titleBiomarker method validation in anticancer drug development.en
dc.typeArticleen
dc.contributor.departmentClinical and Experimental Pharmacology, Paterson Institute for Cancer Research, University of Manchester, Manchester, UK. jcummings@picr.man.ac.uken
dc.identifier.journalBritish Journal of Pharmacologyen

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