Breaking a Vicious Cycle

被引：97

作者：

Hayes, Daniel F. ^{[1
]}

Allen, Jef ^{[2
]}

Compton, Carolyn ^{[3
]}

Gustavsen, Gary ^{[4
]}

Leonard, Debra G. B. ^{[5
]}

McCormack, Robert ^{[6
]}

Newcomer, Lee ^{[7
]}

Pothier, Kristin ^{[4
]}

Ransohof, David ^{[8
]}

Schilsky, Richard L. ^{[9
]}

Sigal, Ellen ^{[2
]}

Taube, Sheila E. ^{[10
]}

Tunis, Sean R. ^{[11
]}

机构：

[1] Univ Michigan, Ctr Comprehens Canc, Ann Arbor, MI 48109 USA

[2] Friends Canc Res, Washington, DC 20036 USA

[3] Crit Path Inst, Tucson, AZ 85257 USA

[4] Hlth Adv, Weston, MA 02090 USA

[5] Univ Vermont, Coll Med, Dept Pathol & Lab Med, Burlington, VT 05405 USA

[6] Veridex, Raritan, NJ 08869 USA

[7] UnitedHealthCare, Minnetonka, MN 55343 USA

[8] Univ N Carolina, Sch Med, Dept Med, Chapel Hill, NC 27599 USA

[9] Amer Soc Clin Oncol, Alexandria, VA 22314 USA

[10] ST Consulting, Bethesda, MD 20817 USA

[11] Ctr Med Technol Policy, Baltimore, MD 21202 USA

来源：

SCIENCE TRANSLATIONAL MEDICINE | 2013年 / 5卷 / 196期

关键词：

TUMOR-MARKERS; AMERICAN SOCIETY; CLINICAL UTILITY; CANCER; BIOMARKERS; INDUSTRY; TRIALS; DESIGN; ASSAY;

D O I：

10.1126/scitranslmed.3005950

中图分类号：

Q2 [细胞生物学];

学科分类号：

071009 ; 090102 ;

摘要：

Despite prodigious advances in tumor biology research, few tumor-biomarker tests have been adopted as standard clinical practice. This lack of reliable tests stems from a vicious cycle of undervaluation, resulting from inconsistent regulatory standards and reimbursement, as well as insufficient investment in research and development, scrutiny of biomarker publications by journals, and evidence of analytical validity and clinical utility. We of er recommendations designed to serve as a roadmap to break this vicious cycle and call for a national dialogue, as changes in regulation, reimbursement, investment, peer review, and guidelines development require the participation of all stakeholders.

引用

页数：7

共 31 条

[1] American Society of Clinical Oncology Provisional Clinical Opinion: Testing for KRAS Gene Mutations in Patients With Metastatic Colorectal Carcinoma to Predict Response to Anti-Epidermal Growth Factor Receptor Monoclonal Antibody Therapy [J].

Allegra, Carmen J. ;

Jessup, J. Milburn ;

Somerfield, Mark R. ;

Hamilton, Stanley R. ;

Hammond, Elizabeth H. ;

Hayes, Daniel F. ;

McAllister, Pamela K. ;

Morton, Roscoe F. ;

Schilsky, Richard L. .

JOURNAL OF CLINICAL ONCOLOGY, 2009, 27 (12) :2091-2096

[2] Biomarker studies: a call for a comprehensive biomarker study registry [J].

Andre, Fabrice ;

McShane, Lisa M. ;

Michiels, Stefan ;

Ransohoff, David F. ;

Altman, Douglas G. ;

Reis-Filho, Jorge S. ;

Hayes, Daniel F. ;

Pusztai, Lajos .

NATURE REVIEWS CLINICAL ONCOLOGY, 2011, 8 (03) :171-176

[3] The pharmaceutical industry - to whom is it accountable? [J].

Angell, M .

NEW ENGLAND JOURNAL OF MEDICINE, 2000, 342 (25) :1902-1904

[4] Excess in the pharmaceutical industry [J].

Angell, M .

CANADIAN MEDICAL ASSOCIATION JOURNAL, 2004, 171 (12) :1451-1453

[5]

[Anonymous], 2012, EVOLUTION TRANSLATIO

[6] NCCN Task Force Report: Evaluating the Clinical Utility of Tumor Markers in Oncology [J].

Febbo, Phillip G. ;

Ladanyi, Marc ;

Aldape, Kenneth D. ;

De Marzo, Angelo M. ;

Hammond, M. Elizabeth ;

Hayes, Daniel F. ;

Iafrate, A. John ;

Kelley, R. Kate ;

Marcucci, Guido ;

Ogino, Shuji ;

Pao, William ;

Sgroi, Dennis C. ;

Birkeland, Marian L. .

JOURNAL OF THE NATIONAL COMPREHENSIVE CANCER NETWORK, 2011, 9 :S1-S32

[7] Randomized Clinical Trials With Biomarkers: Design Issues [J].

Freidlin, Boris ;

McShane, Lisa M. ;

Korn, Edward L. .

JOURNAL OF THE NATIONAL CANCER INSTITUTE, 2010, 102 (03) :152-160

[8]

Gustavsen G, 2010, REIMBURSEMENT LANDSC

[9] American society of clinical oncology 2007 update of recommendations for the use of tumor markers in breast cancer [J].

Harris, Lyndsay ;

Fritsche, Herbert ;

Mennel, Robert ;

Norton, Larry ;

Ravdin, Peter ;

Taube, Sheila ;

Somerfield, Mark R. ;

Hayes, Daniel F. ;

Bast, Robert C., Jr. .

JOURNAL OF CLINICAL ONCOLOGY, 2007, 25 (33) :5287-5312

[10] Is there a role for circulating tumor cells in the management of breast cancer? [J].

Hayes, Daniel F. ;

Smerage, Jeffrey .

CLINICAL CANCER RESEARCH, 2008, 14 (12) :3646-3650

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