Publications by authors named "Lisa M McShane"

100Publications

Bias in retrospective analyses of biomarker effect using data from an outcome-adaptive randomized trial.

Clin Trials 2019 12 3;16(6):599-609. Epub 2019 Oct 3.

Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.

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http://dx.doi.org/10.1177/1740774519875969DOI Listing
December 2019

Rejoinder.

Clin Trials 2019 12 3;16(6):613-615. Epub 2019 Oct 3.

Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.

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http://dx.doi.org/10.1177/1740774519875971DOI Listing
December 2019

Biomarker Validation: Context and Complexities.

Authors:
Lisa M McShane

J Law Med Ethics 2019 09;47(3):388-392

Lisa M. McShane, Ph.D., is with the Biometric Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute in Bethesda, MD.

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http://dx.doi.org/10.1177/1073110519876169DOI Listing
September 2019

Prospects for Minimal Residual Disease as a Surrogate Endpoint in Pediatric Acute Lymphoblastic Leukemia Clinical Trials.

JNCI Cancer Spectr 2018 Oct 19;2(4):pky070. Epub 2018 Dec 19.

Cancer Therapy Evaluation Program, Bethesda, MD.

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http://dx.doi.org/10.1093/jncics/pky070DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6649735PMC
October 2018

Biostatistical and Logistical Considerations in the Development of Basket and Umbrella Clinical Trials.

Cancer J 2019 Jul/Aug;25(4):254-263

From the Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.

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http://dx.doi.org/10.1097/PPO.0000000000000384DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6658126PMC
July 2020

In Reply.

Arch Pathol Lab Med 2019 04 3;143(4):413-414. Epub 2019 Jan 3.

6   The Royal Marsden NHS Foundation Trust, London, United Kingdom.

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http://dx.doi.org/10.5858/arpa.2018-0906-LEDOI Listing
April 2019

Reply to C. Murray et al and V. Martin et al.

J Clin Oncol 2018 Oct 22:JCO1801163. Epub 2018 Oct 22.

Antonio C. Wolff, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; M. Elizabeth Hale Hammond, Intermountain Healthcare and University of Utah School of Medicine, Salt Lake City, UT; Kimberly H. Allison, Stanford University School of Medicine, Stanford, CA; Brittany E. Harvey, American Society of Clinical Oncology, Alexandria, VA; Lisa M. McShane, National Cancer Institute, Bethesda, MD; and Mitchell Dowsett, The Royal Marsden NHS Foundation Trust, London, United Kingdom.

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http://dx.doi.org/10.1200/JCO.18.01163DOI Listing
October 2018

Biomarkers in early-phase trials: fundamental issues.

Bioanalysis 2018 Jun 20;10(12):933-944. Epub 2018 Jun 20.

Division of Cancer Treatment & Diagnosis, National Cancer Institute, National Institutes of Health, Rockville, MD, 20850, USA.

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http://dx.doi.org/10.4155/bio-2018-0006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6123886PMC
June 2018

HER2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update Summary.

J Oncol Pract 2018 07 19;14(7):437-441. Epub 2018 Jun 19.

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD; Intermountain Healthcare and University of Utah School of Medicine, Salt Lake City, UT; Stanford University School of Medicine, Stanford, CA; American Society of Clinical Oncology, Alexandria, VA; National Cancer Institute, Bethesda, MD; and The Royal Marsden NHS Foundation Trust, London, United Kingdom.

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http://dx.doi.org/10.1200/JOP.18.00206DOI Listing
July 2018

Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK): An Abridged Explanation and Elaboration.

J Natl Cancer Inst 2018 08;110(8):803-811

Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

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http://dx.doi.org/10.1093/jnci/djy088DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6093349PMC
August 2018

Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update.

J Clin Oncol 2018 07 30;36(20):2105-2122. Epub 2018 May 30.

Antonio C. Wolff, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore; Lisa M. McShane, National Cancer Institute, Bethesda, MD; M. Elizabeth Hale Hammond, Intermountain Healthcare and University of Utah School of Medicine, Salt Lake City, UT; Kimberly H. Allison, Stanford University School of Medicine, Stanford; Patrick Fitzgibbons, St Jude Medical Center, Fullerton; Michael F. Press, University of Southern California, Los Angeles, CA; Brittany E. Harvey and Pamela B. Mangu, American Society of Clinical Oncology, Alexandria, VA; John M.S. Bartlett, Ontario Institute for Cancer Research; Wedad Hanna, Sunnybrook Health Sciences Centre and Women's College Hospital, Toronto, Ontario, Canada; Michael Bilous, Western Sydney University and Australian Clinical Laboratories, Sydney, New South Wales, Australia; Ian O. Ellis, The University of Nottingham, Nottingham; Mitchell Dowsett, The Royal Marsden NHS Foundation Trust, London, United Kingdom; Robert B. Jenkins, Mayo Clinic, Rochester, MN; Patricia A. Spears, Cancer Information and Support Network, Raleigh, NC; Gail H. Vance, Indiana University School of Medicine, Indianapolis, IN; and Giuseppe Viale, University of Milan and Istituto Europeo di Oncologia, Milan, Italy.

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http://ascopubs.org/doi/10.1200/JCO.2018.77.8738
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http://dx.doi.org/10.1200/JCO.2018.77.8738DOI Listing
July 2018

Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update.

Arch Pathol Lab Med 2018 11 30;142(11):1364-1382. Epub 2018 May 30.

Antonio C. Wolff, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland; Lisa M. McShane, National Cancer Institute, Bethesda, Maryland; M. Elizabeth Hale Hammond, Intermountain Healthcare and University of Utah School of Medicine, Salt Lake City; Kimberly H. Allison, Stanford University School of Medicine, Stanford, California; Patrick Fitzgibbons, St Jude Medical Center, Fullerton, California; Michael F. Press, University of Southern California, Los Angeles; Brittany E. Harvey and Pamela B. Mangu, American Society of Clinical Oncology, Alexandria, Virginia; John M.S. Bartlett, Ontario Institute for Cancer Research, Toronto, Ontario, Canada; Wedad Hanna, Sunnybrook Health Sciences Centre and Women's College Hospital, Toronto, Ontario, Canada; Michael Bilous, Western Sydney University and Australian Clinical Laboratories, Sydney, Australia; Ian O. Ellis, The University of Nottingham, Nottingham, United Kingdom; Mitchell Dowsett, The Royal Marsden NHS Foundation Trust, London, United Kingdom; Robert B. Jenkins, Mayo Clinic, Rochester, Minnesota; Patricia A. Spears, Cancer Information and Support Network, Raleigh, North Carolina; Gail H. Vance, Indiana University School of Medicine, Indianapolis; and Giuseppe Viale, University of Milan and Istituto Europeo di Oncologia, Milan, Italy.

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http://www.archivesofpathology.org/doi/10.5858/arpa.2018-090
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http://dx.doi.org/10.5858/arpa.2018-0902-SADOI Listing
November 2018

Imaging biomarkers exist and they underpin clinical decision-making.

Nat Rev Clin Oncol 2017 11 17;14(11):694. Epub 2017 Oct 17.

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http://dx.doi.org/10.1038/nrclinonc.2017.167DOI Listing
November 2017

Imaging biomarkers exist and they underpin clinical decision-making.

Nat Rev Clin Oncol 2017 07 13;14(7):452. Epub 2017 Jun 13.

Division of Cancer Sciences, University of Manchester, Wilmslow Road, Manchester M20 4BX, UK.

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http://dx.doi.org/10.1038/nrclinonc.2017.84DOI Listing
July 2017

Myeloma Minimal Residual Disease and Surrogacy.

JAMA Oncol 2017 08;3(8):1136

Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Rockville, Maryland.

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http://dx.doi.org/10.1001/jamaoncol.2016.5660DOI Listing
August 2017

Importance of the distinction between quality of methodology and quality of reporting.

HPB (Oxford) 2017 07 21;19(7):649-650. Epub 2017 Apr 21.

National Institutes of Health, National Cancer Institute, 9609 Medical Center Drive, MSC 9735, Bethesda, MD 20892-97, USA.

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http://dx.doi.org/10.1016/j.hpb.2017.02.444DOI Listing
July 2017

Measure for measure: minimal residual disease in CLL.

Blood 2016 12;128(24):2747-2748

NATIONAL INSTITUTES OF HEALTH.

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http://dx.doi.org/10.1182/blood-2016-11-745323DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5159707PMC
December 2016

Imaging biomarker roadmap for cancer studies.

Nat Rev Clin Oncol 2017 03 11;14(3):169-186. Epub 2016 Oct 11.

CRUK and EPSRC Cancer Imaging Centre in Cambridge and Manchester, University of Manchester, Manchester, UK.

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http://dx.doi.org/10.1038/nrclinonc.2016.162DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5378302PMC
March 2017

Issues in developing multivariable molecular signatures for guiding clinical care decisions.

J Biopharm Stat 2016 25;26(6):1098-1110. Epub 2016 Aug 25.

a Biostatistics Branch, Biometric Research Program , National Cancer Institute , Bethesda , Maryland , USA.

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http://dx.doi.org/10.1080/10543406.2016.1226329DOI Listing
November 2017

Reply to D.C. Sgroi et al, T. Sanft et al, M.S. Copur et al, and M.P. Goetz et al.

J Clin Oncol 2016 11;34(32):3946-3948

Lyndsay N. Harris, National Cancer Institute, Bethesda, MD; Nofisat Ismaila, American Society of Clinical Oncology, Alexandria, VA; National Cancer Institute, Bethesda, MD; and Fabrice Andre, Institute Gustave Roussy, Paris, France.

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http://dx.doi.org/10.1200/JCO.2016.68.7020DOI Listing
November 2016

Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Summary.

J Oncol Pract 2016 Apr 8;12(4):384-9. Epub 2016 Mar 8.

Case Western Reserve University, Cleveland, OH; American Society of Clinical Oncology, Alexandria, VA; National Cancer Institute, Bethesda, MD; and University of Michigan Comprehensive Cancer Center, Ann Arbor, MI.

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http://dx.doi.org/10.1200/JOP.2016.010868DOI Listing
April 2016

Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline.

J Clin Oncol 2016 Apr 8;34(10):1134-50. Epub 2016 Feb 8.

Lyndsay N. Harris, Case Western Reserve University, Cleveland, OH; Nofisat Ismaila, American Society of Clinical Oncology, Alexandria, VA; Lisa M. McShane, National Cancer Institute, Bethesda, MD; Fabrice Andre, Institute Gustave Roussy, Paris, France; Deborah E. Collyar, Patient Advocates in Research; Elizabeth H. Hammond, University of Utah and Intermountain Health Care, Salt Lake City, UT; Ana M. Gonzalez-Angulo and Robert C. Bast, The University of Texas MD Anderson Cancer Center, Houston; Robert G.Mennel, Baylor University Medical Center and Texas Oncology PA, Dallas, TX; Nicole M. Kuderer, University of Washington Medical Center, Seattle, WA; Minetta C. Liu, Mayo Clinic College of Medicine, Rochester, MN; and Catherine Van Poznak and Daniel F. Hayes, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI.

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http://jco.ascopubs.org/content/early/2016/02/05/JCO.2015.65
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http://jco.ascopubs.org/cgi/doi/10.1200/JCO.2015.65.2289
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http://dx.doi.org/10.1200/JCO.2015.65.2289DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4933134PMC
April 2016

Refining Prognosis in Lung Cancer: A Report on the Quality and Relevance of Clinical Prognostic Tools.

J Thorac Oncol 2015 Nov;10(11):1576-89

*Division of Cancer Care and Epidemiology, Cancer Research Institute, Queen's University, ON; Canada; †Arizona State University, Phoenix, Arizona; ‡Laboratory Medicine and Pathology, Mayo Clinic School of Medicine, Rochester, Minnesota; §Biometric Research Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland; ‖Department of Biostatistics and Bioinformatics, Duke University and Alliance Statistics and Data Center, Durham, North Carolina; ¶Division of Thoracic Surgery, National Cancer Center Hospital, Tokyo, Japan; and #Department of Thoracic Surgery, Hospital Universitari Mutua Terrassa, Barcelona, Spain.

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http://dx.doi.org/10.1097/JTO.0000000000000652DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4636439PMC
November 2015

Metrology Standards for Quantitative Imaging Biomarkers.

Radiology 2015 Dec 12;277(3):813-25. Epub 2015 Aug 12.

From the Department of Radiology, Duke University Medical Center, Box 2715, Durham, NC 27710 (D.C.S., D.P.B.); Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio (N.A.O.); Department of Public Health, University of Washington, Seattle, Wash (L.G.K.); Department of Informatics, ICON Medical, Washington, Pa (D.L.R.); Center for Statistical Sciences, Brown University, Providence, RI (C.G.); National Cancer Institute, Bethesda, Md (E.P.H., L.M.M.); Center for Devices and Radiological Health, U.S. Food and Drug Administration, White Oak, Md (M.K.); Department of Electrical and Computer Engineering, Cornell University, Ithaca, NY (A.P.R.); Department of Radiology, Oregon Health & Science University, Portland, Ore (A.R.G.); and Mallinckrodt Institute of Radiology, Washington University School of Medicine, St Louis, Mo (R.L.W.).

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http://dx.doi.org/10.1148/radiol.2015142202DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4666097PMC
December 2015

The Fundamental Difficulty With Evaluating the Accuracy of Biomarkers for Guiding Treatment.

J Natl Cancer Inst 2015 Aug 24;107(8). Epub 2015 Jun 24.

Divisions of Vaccine and Infectious Disease and Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington (HJ, MSP); Department of Biostatistics, University of Washington, Seattle, Washington (HJ, MSP, PJH); Biometric Research Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Rockville, Maryland (LMM); Department of Health Science Research, Mayo Clinic, Rochester, Minnesota (DJS).

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http://dx.doi.org/10.1093/jnci/djv157DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4609557PMC
August 2015

Leveraging biospecimen resources for discovery or validation of markers for early cancer detection.

J Natl Cancer Inst 2015 Apr 16;107(4). Epub 2015 Feb 16.

: Division of Cancer Control and Population Sciences (SDS, DMC, LEM, VPDR, MJK), Division of Cancer Prevention (SuS, BSK), and Division of Cancer Treatment and Diagnosis (LMM), National Cancer Institute, Bethesda, MD; Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA (GLA, NU); Department of Medicine, University of North Carolina, Chapel Hill, NC (JAB, DFR); Department of Radiation Oncology, Johns Hopkins Medicine, Baltimore, MD (CDB); Center for Prostate Disease Research, Department of Defense, Rockville, MD (JC); Mount Sinai Hospital, Toronto, Ontario, Canada (EPD); Center for Health Research, Kaiser Permanente, Northwest, Portland, OR (KABG); Division of Biostatistics and Epidemiology, University of Massachusetts, Amherst, MA (SEH); Division of Research, Kaiser Permanente, Oakland, CA (LHK); Group Health Research Institute, Seattle, WA (EBL); American Society of Clinical Oncology, Alexandria, VA (RLS); Genomic Health, Inc., Redwood City, CA (StS); Biostatistics Center, Massachusetts General Hospital, Boston, MA (SJS); Office of Public Health Genomics, Centers for Disease Control and Prevention, Atlanta, GA (MJK).

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http://dx.doi.org/10.1093/jnci/djv012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4342676PMC
April 2015

Comparison of confidence interval methods for an intra-class correlation coefficient (ICC).

BMC Med Res Methodol 2014 Nov 22;14:121. Epub 2014 Nov 22.

Department of Epidemiology and Biostatistics, University of Georgia, Athens, GA, USA.

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http://dx.doi.org/10.1186/1471-2288-14-121DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4258044PMC
November 2014

Registering diagnostic and prognostic trials of tests: is it the right thing to do?

Clin Chem 2014 Sep 22;60(9):1146-52. Epub 2014 May 22.

Director of the Netherlands Trial Register, Amsterdam, the Netherlands; Deputy-director of the Dutch Cochrane Centre, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.

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http://dx.doi.org/10.1373/clinchem.2014.226100DOI Listing
September 2014

Reply to R. Bhargava et al and K. Lambein et al.

J Clin Oncol 2014 Jun 28;32(17):1857-9. Epub 2014 Apr 28.

National Cancer Institute, Bethesda, MD.

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http://dx.doi.org/10.1200/JCO.2014.55.0673DOI Listing
June 2014

Evidence of clinical utility: an unmet need in molecular diagnostics for patients with cancer.

Clin Cancer Res 2014 Mar;20(6):1428-44

Authors' Affiliations: New Enterprise Associates, Inc., Menlo Park; CCS Associates, Mountain View; Myraqa, Redwood Shores, California; Johnson & Johnson/Veridex, LLC, Raritan, New Jersey; University of Texas, MD Anderson Cancer Center, Houston, Texas; Center for Diagnostics and Radiologic Health, Office of In Vitro Diagnostics, Personalized Medicine Program, Silver Spring; Center for Medical Technology Policy, Baltimore; Opus Three LLC; National Cancer Institute, Division of Cancer Treatment and Diagnosis, Rockville, Maryland; and Kaiser Permanente Research Affiliates Evidence-Based Practice Center, Kaiser Permanente Center for Health Research, Portland, Oregon.

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http://dx.doi.org/10.1158/1078-0432.CCR-13-2961DOI Listing
March 2014

Criteria for the use of omics-based predictors in clinical trials: explanation and elaboration.

BMC Med 2013 Oct 17;11:220. Epub 2013 Oct 17.

Biometric Research Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Room 5W130, MSC 9735, 9609 Medical Center Drive, Bethesda, MD 20892-9735, USA.

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http://dx.doi.org/10.1186/1741-7015-11-220DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3852338PMC
October 2013

An international Ki67 reproducibility study.

J Natl Cancer Inst 2013 Dec 7;105(24):1897-906. Epub 2013 Nov 7.

Affiliations of authors: Biometric Research Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (MCP, LMM); Pathology and Laboratory Medicine, University of British Columbia, Vancouver, British Columbia, Canada (SCYL, DG, EM, TON); Department of Laboratory Medicine and Pathology, University of Alberta, Alberta, Canada (JCH); Division of Pathology and Laboratory Medicine, European Institute of Oncology, Milan, Italy (MGM); Division of Pathology and Laboratory Medicine, European Institute of Oncology, and University of Milan, Milan, Italy (GV); Breakthrough Breast Cancer Research Centre, The Institute of Cancer Research, London, United Kingdom (LAZ); Department of Pathology, Centre Jean Perrin, Clermont-Ferrand, and Université d'Auvergne, France (FP-L); Transformative Pathology, Ontario Institute for Cancer Research, Toronto, Ontario, Canada (JMSB); PhenoPath Laboratories, Seattle, WA (AMG); Department of Pathology, MD Anderson Cancer Center, Houston, TX (WFS); Edinburgh Cancer Research Centre, Western General Hospital, Edinburgh, United Kingdom (TP); The EMMES Corporation, Rockville, MD (RAE); Breast Oncology Program, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI (DFH); Academic Department of Biochemistry, Royal Marsden Hospital, London, United Kingdom (MD); on behalf of the International Ki67 in Breast Cancer Working Group of the Breast International Group and North American Breast Cancer Group.

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http://dx.doi.org/10.1093/jnci/djt306DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3888090PMC
December 2013

Statistical and practical considerations for clinical evaluation of predictive biomarkers.

J Natl Cancer Inst 2013 Nov 17;105(22):1677-83. Epub 2013 Oct 17.

Affiliations of authors: Biometric Research Branch (M-YCP, BF, ELK, LMS), Cancer Diagnosis Program (BAC), and Cancer Treatment and Evaluation Program (JSA), Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, MD.

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http://dx.doi.org/10.1093/jnci/djt282DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3888208PMC
November 2013

Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update.

J Clin Oncol 2013 Nov 7;31(31):3997-4013. Epub 2013 Oct 7.

Antonio C. Wolff, Johns Hopkins Kimmel Comprehensive Cancer Center, Baltimore; Lisa M. McShane, National Cancer Institute, Bethesda, MD; M. Elizabeth H. Hammond, University of Utah School of Medicine and Intermountain Healthcare, Salt Lake City, UT; David G. Hicks, University of Rochester Medical Center, Rochester, NY; Mitch Dowsett, Royal Marsden Hospital, London, United Kingdom; Kimberly H. Allison, Stanford University Medical Center, Stanford; Patrick Fitzgibbons, St Jude Medical Center, Fullerton; Michael F. Press, University of Southern California, Los Angeles, CA; Donald C. Allred, Washington University School of Medicine, St Louis, MO; John M.S. Bartlett, Ontario Institute for Cancer Research; Wedad Hanna, Sunnybrook Health Sciences Center, Toronto, Ontario, Canada; Michael Bilous, University of Western Sydney and Healthscope Pathology, Sydney, New South Wales, Australia; Robert B. Jenkins, Mayo Clinic, Rochester, MN; Pamela B. Mangu, American Society of Clinical Oncology, Alexandria, VA; Soonmyung Paik, National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Patricia A. Spears, North Carolina State University, Raleigh, NC; Gail H. Vance, Indiana University Medical Center, Indianapolis, IN; Giuseppe Viale, University of Milan, European Institute of Oncology, Milan, Italy; and Daniel F. Hayes, University of Michigan Comprehensive Cancer Care Center, Ann Arbor, MI.

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http://dx.doi.org/10.1200/JCO.2013.50.9984DOI Listing
November 2013

Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update.

Arch Pathol Lab Med 2014 Feb 7;138(2):241-56. Epub 2013 Oct 7.

Antonio C. Wolff, Johns Hopkins Kimmel Comprehensive Cancer Center, Baltimore; Lisa M. McShane, National Cancer Institute, Bethesda, MD; M. Elizabeth H. Hammond, University of Utah School of Medicine and Intermountain Healthcare, Salt Lake City, UT; David G. Hicks, University of Rochester Medical Center, Rochester, NY; Mitch Dowsett, Royal Marsden Hospital, London, United Kingdom; Kimberly H. Allison, Stanford University Medical Center, Stanford; Patrick Fitzgibbons, St Jude Medical Center, Fullerton; Michael F. Press, University of Southern California, Los Angeles, CA; Donald C. Allred, Washington University School of Medicine, St Louis, MO; John M.S. Bartlett, Ontario Institute for Cancer Research; Wedad Hanna, Sunnybrook Health Sciences Center, Toronto, Ontario, Canada; Michael Bilous, University of Western Sydney and Healthscope Pathology, Sydney, New South Wales, Australia; Robert B. Jenkins, Mayo Clinic, Rochester, MN; Pamela B. Mangu, American Society of Clinical Oncology, Alexandria, VA; Soonmyung Paik, National Surgical Adjuvant Breast and Bowel Project, Pitsburgh, PA; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Patricia A. Spears, North Carolina State University, Raleigh, NC; Gail H. Vance, Indiana University Medical Center, Indianapolis, IN; Giuseppe Viale, University of Milan, European Institute of Oncology, Milan, Italy; and Daniel F. Hayes, University of Michigan Comprehensive Cancer Care Center, Ann Arbor, MI.

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http://dx.doi.org/10.5858/arpa.2013-0953-SADOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4086638PMC
February 2014

Development of omics-based clinical tests for prognosis and therapy selection: the challenge of achieving statistical robustness and clinical utility.

Clin Trials 2013 Oct 2;10(5):653-65. Epub 2013 Sep 2.

Biometric Research Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA.

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http://dx.doi.org/10.1177/1740774513499458DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4410005PMC
October 2013

Statistical challenges in the evaluation of treatments for small patient populations.

Sci Transl Med 2013 Mar;5(178):178sr3

Biometric Research Branch, MSC 9735, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD 20892, USA.

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http://dx.doi.org/10.1126/scitranslmed.3004018DOI Listing
March 2013

Publication of tumor marker research results: the necessity for complete and transparent reporting.

J Clin Oncol 2012 Dec 15;30(34):4223-32. Epub 2012 Oct 15.

Biometric Research Branch and Cancer Diagnosis Program, National Cancer Institute, Bethesda, MD 20892-7434, USA.

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http://dx.doi.org/10.1200/JCO.2012.42.6858DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3504327PMC
December 2012

Randomized phase II trial designs with biomarkers.

J Clin Oncol 2012 Sep 6;30(26):3304-9. Epub 2012 Aug 6.

Biometric Research Branch, EPN-8129, National Cancer Institute, Bethesda, MD 20852, USA.

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http://dx.doi.org/10.1200/JCO.2012.43.3946DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3434989PMC
September 2012

Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK): explanation and elaboration.

PLoS Med 2012 29;9(5):e1001216. Epub 2012 May 29.

Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom.

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http://dx.doi.org/10.1371/journal.pmed.1001216DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3362085PMC
August 2012

Statistical challenges in the development and evaluation of marker-based clinical tests.

Authors:
Lisa M McShane

BMC Med 2012 May 29;10:52. Epub 2012 May 29.

Biometric Research Branch and Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, 6130 Executive Boulevard, EPN 8126, Bethesda, MD 20892-7434, USA.

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http://dx.doi.org/10.1186/1741-7015-10-52DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3379945PMC
May 2012

Biospecimen reporting for improved study quality (BRISQ).

Clin Chim Acta 2012 Aug 18;413(15-16):1305. Epub 2012 Apr 18.

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http://dx.doi.org/10.1016/j.cca.2012.04.013DOI Listing
August 2012

Biospecimen reporting for improved study quality (BRISQ).

Cancer Cytopathol 2011 Apr 22;119(2):92-101. Epub 2011 Mar 22.

Office of Biorepositories and Biospecimen Research, National Cancer Institute, Bethesda, Maryland, USA.

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http://dx.doi.org/10.1002/cncy.20147DOI Listing
April 2011

Biomarker studies: a call for a comprehensive biomarker study registry.

Nat Rev Clin Oncol 2011 Mar;8(3):171-6

Department of Medical Oncology and INSERM U981 Institut Gustave Roussy, 39 Rue Camilles Desmoulins, Villejuif 94805, France.

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http://dx.doi.org/10.1038/nrclinonc.2011.4DOI Listing
March 2011

Evaluation of normalization methods for two-channel microRNA microarrays.

J Transl Med 2010 Jul 21;8:69. Epub 2010 Jul 21.

Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.

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http://dx.doi.org/10.1186/1479-5876-8-69DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2917409PMC
July 2010

Randomized clinical trials with biomarkers: design issues.

J Natl Cancer Inst 2010 Feb 14;102(3):152-60. Epub 2010 Jan 14.

Biometric Research Branch, EPN-8122, National Cancer Institute, Bethesda, MD 20892, USA.

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http://dx.doi.org/10.1093/jnci/djp477DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2911042PMC
February 2010

MicroRNA expression differentiates histology and predicts survival of lung cancer.

Clin Cancer Res 2010 Jan 12;16(2):430-41. Epub 2010 Jan 12.

Genetic Epidemiology Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, NIH, Department of Health and Human Services, Bethesda, Maryland 20892-7236, USA.

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http://dx.doi.org/10.1158/1078-0432.CCR-09-1736DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3163170PMC
January 2010

A perspective on challenges and issues in biomarker development and drug and biomarker codevelopment.

J Natl Cancer Inst 2009 Nov 23;101(21):1453-63. Epub 2009 Oct 23.

ST-Consulting, PO Box 260, Glen Echo, MD 20812-0260, USA.

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http://dx.doi.org/10.1093/jnci/djp334DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2773185PMC
November 2009

Profiling human serum antibodies with a carbohydrate antigen microarray.

J Proteome Res 2009 Sep;8(9):4301-10

Laboratory of Medicinal Chemistry, National Cancer Institute, Frederick, MD 21702, USA.

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http://pubs.acs.org/doi/abs/10.1021/pr900515y
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http://dx.doi.org/10.1021/pr900515yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2738755PMC
September 2009

Effective incorporation of biomarkers into phase II trials.

Clin Cancer Res 2009 Mar 10;15(6):1898-905. Epub 2009 Mar 10.

Biometric Research Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland, USA.

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http://linus.nci.nih.gov/techreport/McShane_etal_CCR_2009_fi
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http://dx.doi.org/10.1158/1078-0432.CCR-08-2033DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2874890PMC
March 2009

A class comparison method with filtering-enhanced variable selection for high-dimensional data sets.

Stat Med 2008 Dec;27(28):5834-49

Department of Medical Informatics, University of Ljubljana, Slovenia.

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http://dx.doi.org/10.1002/sim.3405DOI Listing
December 2008

Challenges in projecting clustering results across gene expression-profiling datasets.

J Natl Cancer Inst 2007 Nov 13;99(22):1715-23. Epub 2007 Nov 13.

Department of Experimental Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.

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http://dx.doi.org/10.1093/jnci/djm216DOI Listing
November 2007

An investigation of two multivariate permutation methods for controlling the false discovery proportion.

Stat Med 2007 Oct;26(24):4428-40

Biometric Research Branch, National Cancer Institute, EPN-8129, Bethesda, MD 20892-7434, USA.

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http://dx.doi.org/10.1002/sim.2865DOI Listing
October 2007

REporting recommendations for tumor MARKer prognostic studies (REMARK).

Breast Cancer Res Treat 2006 Nov 24;100(2):229-35. Epub 2006 Aug 24.

Biometric Research Branch, DCTD, National Cancer Institute, Room 8126, Executive Plaza North, 6130 Executive Boulevard, Bethesda, MD 20892-7434, USA.

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http://dx.doi.org/10.1007/s10549-006-9242-8DOI Listing
November 2006

Appropriateness of some resampling-based inference procedures for assessing performance of prognostic classifiers derived from microarray data.

Stat Med 2007 Feb;26(5):1102-13

Department of Experimental Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milano, Italy.

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http://dx.doi.org/10.1002/sim.2598DOI Listing
February 2007

REporting recommendations for tumor MARKer prognostic studies (REMARK).

Nat Clin Pract Urol 2005 Aug;2(8):416-22

National Cancer Institute, Biometric Research Branch, Bethesda, MD 20892-7434, USA.

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August 2005

Reporting recommendations for tumor marker prognostic studies.

J Clin Oncol 2005 Dec 19;23(36):9067-72. Epub 2005 Sep 19.

Biometric Research Branch, National Cancer Institute, Bethesda, MD, USA.

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December 2005

REporting recommendations for tumor MARKer prognostic studies (REMARK).

Nat Clin Pract Oncol 2005 Aug;2(8):416-22

National Cancer Institute, Biometric Research Branch, DCTD, Room 8126, Executive Plaza North, MSC 7434, 6130 Executive Boulevard, Bethesda, MD 20892-7434, USA.

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August 2005

Reporting recommendations for tumor marker prognostic studies (REMARK).

J Natl Cancer Inst 2005 Aug;97(16):1180-4

Biometric Research Branch, National Cancer Institute, Executive Plaza North, 6130 Executive Blvd., Bethesda, MD 20892-7434, USA.

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http://jnci.oxfordjournals.org/cgi/doi/10.1093/jnci/dji237
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August 2005

REporting recommendations for tumour MARKer prognostic studies (REMARK).

Eur J Cancer 2005 Aug;41(12):1690-6

National Cancer Institute, Biometric Research Branch, DCTD, Room 8126, Executive Plaza North, MSC 7434, 6130 Executive Boulevard, Bethesda, MD 20892-7434, USA.

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http://www.elsevier.com/__data/promis_misc/remarkejc.pdf
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http://dx.doi.org/10.1016/j.ejca.2005.03.032DOI Listing
August 2005

Assessing surrogates as trial endpoints using mixed models.

Stat Med 2005 Jan;24(2):163-82

Biometric Research Branch, EPN-8128, National Cancer Institute, Bethesda, MD 20892, USA.

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http://dx.doi.org/10.1002/sim.1779DOI Listing
January 2005

Chromosome transfer induced aneuploidy results in complex dysregulation of the cellular transcriptome in immortalized and cancer cells.

Cancer Res 2004 Oct;64(19):6941-9

Genetics Branch and Laboratory for Biosystems and Cancer, Center for Cancer Research and Biometric Research Branch, National Cancer Institute/NIH, Bethesda, Maryland 20892-8010, USA.

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http://dx.doi.org/10.1158/0008-5472.CAN-04-0474DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4772432PMC
October 2004

Objective method of comparing DNA microarray image analysis systems.

Biotechniques 2004 Jun;36(6):960-7

Biometric Research Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.

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http://dx.doi.org/10.2144/04366BI01DOI Listing
June 2004

Correcting log ratios for signal saturation in cDNA microarrays.

Bioinformatics 2004 Nov 14;20(16):2685-93. Epub 2004 May 14.

Biometric Research Branch, DCTD, National Cancer Institute, Bethesda, MD 20892-7434, USA.

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http://dx.doi.org/10.1093/bioinformatics/bth309DOI Listing
November 2004

Statistical issues in the design and analysis of gene expression microarray studies of animal models.

J Mammary Gland Biol Neoplasia 2003 Jul;8(3):359-74

Biometric Research Branch, National Cancer Institute, Bethesda, Maryland 20892, USA.

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http://dx.doi.org/10.1023/b:jomg.0000010035.57912.5aDOI Listing
July 2003

Breast cancer classification and prognosis based on gene expression profiles from a population-based study.

Proc Natl Acad Sci U S A 2003 Sep 13;100(18):10393-8. Epub 2003 Aug 13.

Division of Clinical Sciences, National Cancer Institute, Advanced Technology Center, 8717 Grovemont Circle, Gaithersburg, MD 20877, USA.

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http://www.pnas.org/cgi/doi/10.1073/pnas.1732912100
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC193572PMC
September 2003