Measuring Soluble Biomarkers in Clinical Trials: Do Tiered Approaches to The Analysis and Validation of Assays Provide an Answer to The Fit-For-Purpose Challenge?

Abstract

BioanalysisVol. 6, No. 5 Mini Focus Issue: Tiered approach to bioanalysis - CommentaryMeasuring soluble biomarkers in clinical trials: do tiered approaches to the analysis and validation of assays provide an answer to the fit-for-purpose challenge?Richard Hucker, Carl Watson, Ian James, Scott Vincent & David MuirheadRichard Hucker* Author for correspondenceA4P Consulting Limited, Innovation House, Discovery Park, Sandwich, Kent, CT13 9NJ, UK. Search for more papers by this authorEmail the corresponding author at richard.hucker@a4pbio.com, Carl WatsonA4P Consulting Limited, Innovation House, Discovery Park, Sandwich, Kent, CT13 9NJ, UKSearch for more papers by this author, Ian JamesA4P Consulting Limited, Innovation House, Discovery Park, Sandwich, Kent, CT13 9NJ, UKSearch for more papers by this author, Scott VincentA4P Consulting Limited, Innovation House, Discovery Park, Sandwich, Kent, CT13 9NJ, UKSearch for more papers by this author & David MuirheadA4P Consulting Limited, Innovation House, Discovery Park, Sandwich, Kent, CT13 9NJ, UKSearch for more papers by this authorPublished Online:12 Mar 2014https://doi.org/10.4155/bio.14.11AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail View articleKeywords: biomarkersclinicalfit-for-purposetiered approachvalidationReferences1 Boulton M, Dally J. Biomarkers in oncology drug development. Regulatory Rapporteur7(4), (2010).Google Scholar2 Katz R. Biomarkers and surrogate markers: an FDA perspective. NeuroRx1,189–195 (2004).Crossref, Medline, Google Scholar3 Lesko L, Atkinson A. Use of biomarkers and surrogate end points in drug development and regulatory decision making. Ann. Rev. Pharmacol. Toxicol.41,347–366 (2001).Crossref, Medline, CAS, Google Scholar4 Paul SM, Mytelka DS, Dunwiddie CT et al. How to improve R&D productivity: the pharmaceutical industry’s grand challenge. Nat. Rev. Drug Discov.9,203–214 (2010).Crossref, Medline, CAS, Google Scholar5 BoothB. When do you need a validated assay? Bioanalysis3(24),2729–2730 (2011).Link, CAS, Google Scholar6 Lee JW, Devanarayan V, Barrett YC et al. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm. Res.23(2),312–328 (2006).Crossref, Medline, CAS, Google Scholar7 FDA Guidance for industry: bioanalytical method validation draft guidance September 2013.Google Scholar8 Timmerman P, Herling C, Stoellner D et al. European Bioanalysis Forum recommendations on method establishment and bioanalysis of biomarkers in support of drug development. Bioanalysis4(15),1883–1894 (2012).Link, CAS, Google Scholar9 EMA GCP Inspectors Working Group. Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples. EMA/INS/GCP/532137/2010 28 February 2012.Google Scholar10 Timmerman P, Anders L, Kall M, Gordon B, Laakso S, Freisleben A, Hucker R. Best practices in a tiered approach to metabolite quantification: views and recommendations of the European Bioanalysis Forum. Bioanalysis2(7),1185–1194 (2010).Link, Google Scholar11 Watson CJ et al. Fit for purpose biomarker validation. Presented at: 8th Annual Biomarkers Conference. Manchester, UK, 19–20 February 2013.Google ScholarFiguresReferencesRelatedDetailsCited ByEnsuring quality and compliance in outsourcing of bioanalysis of clinical biomarkersTianke Wang & Arkady I Gusev16 March 2017 | Bioanalysis, Vol. 9, No. 7Surrogate matrix: opportunities and challenges for tissue sample analysisStacy Ho & Hong Gao23 September 2015 | Bioanalysis, Vol. 7, No. 18Scientific or regulated validation: a tiered approach? Meeting report from a joint EBF/DVDMDG workshopPhilip Timmerman, Steve Lowes, Stuart McDougall, Irina Colligon, Joy Miksic, Swapan Chowdhury, Steve White, Anne-Françoise Aubry, Rand Jenkins & Christopher Kemper13 August 2015 | Bioanalysis, Vol. 7, No. 14Tiered approach to metabolite quantification: regional practices reviewed by Japan Bioanalysis Forum discussion groupMakoto Niwa, Takahide Uchimura, Nozomu Koseki, Masahiro Satsukawa, Yoshitaka Hashimoto, Tsuyoshi Mayumi, Yutaka Yasuda & Hiroyuki Yokoi12 May 2015 | Bioanalysis, Vol. 7, No. 8 Vol. 6, No. 5 Follow us on social media for the latest updates Metrics Downloaded 274 times History Published online 12 March 2014 Published in print March 2014 Information© Future Science LtdKeywordsbiomarkersclinicalfit-for-purposetiered approachvalidationFinancial & competing interests disclosureThe authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.No writing assistance was utilized in the production of this manuscript.PDF download