Implementation of proteomic biomarkers: making it work

被引：131

作者：

Mischak, Harald ^{[1
,2
]}

Ioannidis, John P. A. ^{[3
,4
,5
,6
]}

Argiles, Angel ^{[7
]}

Attwood, Teresa K. ^{[8
,9
]}

Bongcam-Rudloff, Erik ^{[10
,11
]}

Broenstrup, Mark ^{[12
]}

Charonis, Aristidis ^{[13
,38
]}

Chrousos, George P. ^{[14
]}

Delles, Christian ^{[1
]}

Dominiczak, Anna ^{[1
]}

Dylag, Tomasz ^{[15
]}

Ehrich, Jochen ^{[16
]}

Egido, Jesus ^{[17
]}

Findeisen, Peter ^{[18
]}

Jankowski, Joachim ^{[19
]}

Johnson, Robert W. ^{[20
]}

Julien, Bruce A. ^{[21
]}

Lankisch, Tim ^{[22
]}

Leung, Hing Y. ^{[23
]}

Maahs, David ^{[24
]}

Magni, Fulvio ^{[25
]}

Manns, Michael P. ^{[22
]}

Manolis, Efthymios ^{[26
]}

Mayer, Gert ^{[27
]}

Navis, Gerjan ^{[28
]}

Novak, Jan ^{[29
]}

Ortiz, Alberto ^{[17
]}

Persson, Frederik ^{[30
]}

Peter, Karlheinz ^{[31
]}

Riese, Hans H. ^{[32
]}

Rossing, Peter ^{[30
]}

Sattar, Naveed ^{[1
]}

Spasovski, Goce ^{[33
]}

Thongboonkerd, Visith ^{[34
]}

Vanholder, Raymond ^{[35
]}

Schanstra, Joost P. ^{[36
,37
]}

Vlahou, Antonia ^{[38
]}

机构：

[1] Univ Glasgow, Coll Med Vet & Life Sci, Inst Cardiovasc & Med Sci, BHF Glasgow Cardiovasc Res Ctr, Glasgow G12 8TA, Lanark, Scotland

[2] Mosaiques Diagnost, D-30625 Hannover, Germany

[3] Univ Ioannina, Sch Med, Dept Hyg & Epidemiol, Clin & Mol Epidemiol Unit, GR-45110 Ioannina, Greece

[4] Stanford Univ, Stanford Prevent Res Ctr, Dept Med, Sch Med, Stanford, CA 94305 USA

[5] Stanford Univ, Dept Hlth Res & Policy, Sch Med, Stanford, CA 94305 USA

[6] Stanford Univ, Dept Stat, Sch Humanities & Sci, Stanford, CA 94305 USA

[7] RD Nephrol, F-34090 Montpellier, France

[8] Univ Manchester, Fac Life Sci, Manchester M13 9PL, Lancs, England

[9] Univ Manchester, Sch Comp Sci, Manchester M13 9PL, Lancs, England

[10] Uppsala Univ, Dept Immunol Genet & Pathol, SE-75124 Uppsala, Sweden

[11] Swedish Univ Agr Sci, Dept Anim Breeding & Genet, SE-75124 Uppsala, Sweden

[12] Sanofi Aventis Deutschland GmbH, D-65926 Frankfurt, Germany

[13] Acad Athens, Biomed Res Fdn, Div Histol, Athens 11527, Greece

[14] Univ Athens, Sch Med, Dept Pediat 1, Aghia Sophia Childrens Hosp, GR-11527 Athens, Greece

[15] Commiss European Communities, Directorate Gen Res & Innovat, Unit Personalised Med F5, B-1049 Brussels, Belgium

[16] Hannover Med Sch, Dept Pediat, D-30625 Hannover, Germany

[17] Univ Autonoma Madrid, IIS Fdn Jimenez Diaz, Madrid, Spain

[18] Univ Klinikum Mannheim, Inst Clin Chem C, D-68167 Mannheim, Germany

[19] Charite CBF, Med Klin 4, D-12200 Berlin, Germany

[20] Abbott Labs, Abbott Pk, IL 60064 USA

[21] Univ Alabama Birmingham, Dept Med, Birmingham, AL 35294 USA

[22] Hannover Med Sch, Dept Gastroenterol Hepatol & Endocrinol, D-30625 Hannover, Germany

[23] Beatson Inst Canc Res, Glasgow G61 1BD, Lanark, Scotland

[24] Univ Colorado Denver, Barbara Davis Ctr Childhood Diabet, Aurora, CO USA

[25] Univ Milano Bicocca, Dept Expt Med, Monza, Italy

[26] European Med Agcy, London, England

[27] Med Univ Innsbruck, Dept Internal Med 4, A-6020 Innsbruck, Austria

[28] Univ Groningen, Univ Med Ctr Groningen, Div Nephrol, Dept Internal Med, Groningen, Netherlands

[29] Univ Alabama Birmingham, Dept Microbiol, Birmingham, AL 35294 USA

[30] Steno Diabet Ctr, DK-2820 Gentofte, Denmark

[31] Baker Heart Res Inst, Melbourne, Vic 8008, Australia

[32] Inst Hlth Carlos III, European Projects Off, Madrid, Spain

[33] Univ Skopje, Fac Med, Dept Nephrol, Skopje 1000, Macedonia

[34] Mahidol Univ, Fac Med, Siriraj Hosp, Bangkok 10700, Thailand

[35] Ghent Univ Hosp, Dept Nephrol, B-9000 Ghent, Belgium

[36] Fac Med Toulouse, INSERM, U1048, Inst Cardiovasc & Metab Dis, F-31073 Toulouse, France

[37] Univ Toulouse 3, F-31062 Toulouse, France

[38] Acad Athens, Biomed Res Fdn, Div Biotechnol, Athens 11527, Greece

来源：

EUROPEAN JOURNAL OF CLINICAL INVESTIGATION | 2012年 / 42卷 / 09期

关键词：

Biomarker; biomarker implementation; clinical proteomics; clinical studies; expert panel; proteomics; CHRONIC KIDNEY-DISEASE; MASS-SPECTROMETRY; CLINICAL PROTEOMICS; CANCER BIOMARKERS; DRUG DEVELOPMENT; EUROPEAN BIOBANKS; CONTROLLED-TRIAL; MICROALBUMINURIA; VALIDATION; CANDESARTAN;

D O I：

10.1111/j.1365-2362.2012.02674.x

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Eur J Clin Invest 2012; 42 (9): 10271036 Abstract While large numbers of proteomic biomarkers have been described, they are generally not implemented in medical practice. We have investigated the reasons for this shortcoming, focusing on hurdles downstream of biomarker verification, and describe major obstacles and possible solutions to ease valid biomarker implementation. Some of the problems lie in suboptimal biomarker discovery and validation, especially lack of validated platforms with well-described performance characteristics to support biomarker qualification. These issues have been acknowledged and are being addressed, raising the hope that valid biomarkers may start accumulating in the foreseeable future. However, successful biomarker discovery and qualification alone does not suffice for successful implementation. Additional challenges include, among others, limited access to appropriate specimens and insufficient funding, the need to validate new biomarker utility in interventional trials, and large communication gaps between the parties involved in implementation. To address this problem, we propose an implementation roadmap. The implementation effort needs to involve a wide variety of stakeholders (clinicians, statisticians, health economists, and representatives of patient groups, health insurance, pharmaceutical companies, biobanks, and regulatory agencies). Knowledgeable panels with adequate representation of all these stakeholders may facilitate biomarker evaluation and guide implementation for the specific context of use. This approach may avoid unwarranted delays or failure to implement potentially useful biomarkers, and may expedite meaningful contributions of the biomarker community to healthcare.

引用

页码：1027 / 1036

页数：10

共 45 条

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