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Biometric Research Program (BRP)

Dr. Lisa Meier McShane

Acting Associate Director, Division of Cancer Treatment and Diagnosis


Lisa Meier McShane, Ph.D., leads the Biometric Research Program, Division of Cancer Treatment and Diagnosis, U.S. National Cancer Institute, National Institutes of Health. She was formerly Chief of the Biostatistics Branch within the program and now has oversight and strategic planning responsibilities for both branches in the program, including additionally the Computational and Systems Biology Branch. She holds a doctoral degree in Statistics from Cornell University in Ithaca, NY and is an elected Fellow of the American Statistical Association. She is a recognized expert in development of tumor marker-based tests for prognosis, therapy selection, and disease monitoring.

Dr. McShane serves on the Scientific Advisory Board for Science Translational Medicine and the Editorial Board for BMC Medicine. She has served on American Society of Clinical Oncology committees that developed guidelines for HER2 and hormone receptor testing in breast cancer, EGFR mutation testing in lung cancer, and biomarkers in early stage breast cancer. She interacts frequently with FDA on biomarker-based initiatives and has served on FDA/CDRH Molecular and Clinical Genetics and Clinical Chemistry and Clinical Toxicology Panels. She has served as a member of Institute of Medicine Committee for Management of the Air Force Health Study Data and Specimens, the Consensus Committee on Management of the Air Force Health Study Data and Specimens-Report to Congress, and the Committee on the State of the Science in Ovarian Cancer Research.

Research Interests

Dr. McShane's research interests include biomarker-driven clinical trial design, statistical analysis of high-dimensional omics data, multiple comparisons methods, surrogate endpoint evaluation, measurement error models, biomarker assay analytical performance assessment, and evidence-based medicine approaches for the evaluation of clinical diagnostic tests. She co-led efforts to develop "Reporting guidelines for tumor marker prognostic studies (REMARK)" and "Criteria for the use of omics-based predictors in clinical trials". She has coauthored numerous statistical and biomedical papers in addition to the book Statistical Design and Analysis of DNA Microarray Investigations. She is a frequent invited speaker at national and international oncology and statistics meetings.

CV (Updated on July 3, 2017)

Selected peer-reviewed publications (within last 5 years):

1. Altman DG, McShane LM, Sauerbrei W, Taube SE. Reporting recommendations for tumor marker prognostic studies (REMARK): Explanation and elaboration. Simultaneously published in the following journals: BMC Medicine 10: 51 (, 2012; PLoS Medicine 9(5): e1001216, 2012.

2. Freidlin B, McShane LM, Polley M-YC, Korn EL. Randomized phase II designs with biomarkers. Journal of Clinical Oncology 30(26): 3304-3309, 2012.

3. Korn EL, McShane LM, Freidlin B. Statistical challenges in evaluation of treatments for rare diseases and for small targeted patient subgroups. Science Translational Medicine 5(178): 178sr3, 2013.

4. McShane LM, Polley M-YC. Development of omics-based clinical tests: The challenge of achieving statistical robustness and clinical utility. Clinical Trials 10: 653-665, 2013.

5. McShane LM, Cavenagh MM, Lively TG, Eberhard DA, Bigbee WL, Williams PM, Mesirov JP, Polley M-YC, Kim KY, Tricoli JV, Taylor JMG, Shuman DJ, Simon RM, Doroshow JH, Conley BA. Criteria for the use of omics-based predictors in clinical trials. Nature 502: 317-320, 2013.

6. McShane LM, Cavenagh MM, Lively TG, Eberhard DA, Bigbee WL, Williams PM, Mesirov JP, Polley M-YC, Kim KY, Tricoli JV, Taylor JMG, Shuman DJ, Simon RM, Doroshow JH, Conley BA. Criteria for the use of omics-based predictors in clinical trials: Explanation & elaboration. BMC Medicine 11:220, 2013.

7. Wolff AC, Hammond ME, Hicks DG, Dowsett M, McShane LM, Allison KH, Allred DC, Bartlett JMS, Bilous M, Fitzgibbons P, Hanna W, Jenkins RB, Mangu PB, Paik S, Perez EA, Press MF, Spears PA, Vance GH, Viale G, Hayes DF. 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. Journal of Clinical Oncology 31(31): 3997-4013, 2013. Co-published in the journal: Archives of Pathology and Laboratory Medicine 138(2): 241-256, 2014.

8. Polley M-YC, Freidlin B, Korn EL, Conley BA, Abrams, JS, McShane LM. Statistical and Practical Considerations for Clinical Evaluation of Predictive Biomarkers. Journal of the National Cancer Institute 105(22): 1677-1683, 2013.

9. Kim KY, McShane LM, Conley BA. Designing biomarker studies for head and neck cancer. Head and Neck 36(7): 1069-1075, 2014.

10. Ionan A, Polley M-YC, McShane LM, Dobbin KK. Frequentist properties of interval estimates of the intra-class correlation coefficient (ICC). BMC Medical Research Methodology 14:121, 2014.

11. Huang EP, Wang X-F, Choudhury KR, McShane LM, Gonen M, Ye J, Buckler AJ, Kinahan P, Reeves AP, Jackson EF, Guimaraes AR, Zahlmann G. Meta-analysis of the technical performance of an imaging assay: Guidelines and statistical methodology. Statistical Methods in Medical Research 24(1): 141-174, 2015.

12. Raunig DL, McShane LM, Pennello G, Gatsonis C, Carson PL, Voyvodic JT, Wahl RL, Kurland BF, Schwarz AJ, Gonen M, Zahlmann G , Kondratovich M, O.Donnell K, Petrick N, Cole PE, Garra B, Sullivan DC. Quantitative imaging biomarkers: A review of statistical methods for technical performance assessment. Statistical Methods in Medical Research 24(1): 27-67, 2015.

13. Carrick DM, Mehaffey MG , Sachs MC, Altekruse S, Camalier C, Chuaqui R, Cozen W, Das B, Hernandez BY, Lih C-J, Lynch CF, Makhlouf H, McGregor P, McShane LM, Phillips Rohan J, Walsh WD, Williams PM, Gillanders EM, Mechanic LE, Schully SD. Robustness of Next Generation Sequencing on Older Formalin-Fixed Paraffin-Embedded Tissue. PLoS ONE 10(7): e0127353, 2015.

14. Janes H, Pepe MS, McShane LM, Sargent DJ, Heagerty PJ. The fundamental difficulty with evaluating the accuracy of biomarkers for guiding treatment. Journal of the National Cancer Institute 107(8): djv157, 2015.

15. Sullivan DC, Obuchowski N, Kessler LG, Raunig DL, Gatsonis C, Huang EP, Kondratovich M, McShane LM, Reeves AP, Barboriak DP, Guimaraes AR, Wahl RL for the RSNA-QIBA Metrology Working Group. Metrology standards for quantitative imaging biomarkers. Radiology 277(3): 813-825, 2015.

16. Mahar A, Compton C, McShane LM, Halabi S, Asamura H, Rami-Porta R, Groome PA. Refining prognosis in lung cancer: a report on the quality and relevance of clinical prognostic tools. Journal of Thoracic Oncology 10(11): 1576-1589, 2015.

17. Korn EL, Sachs MC, McShane LM. Assessing pathologic complete response as a trial-level surrogate endpoint for early-stage breast cancer. Annals of Oncology 27(1): 10-15, 2016.

18. Harris LN, Ismaila N, McShane LM, Andre F, Collyar DE, Gonzalez-Angulo AM, Hammond EH, Kuderer NM, Liu MC, Mennel RG, Van Poznak C, Bast RC, Hayes DF. 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. Journal of Clinical Oncology 34: 1134-1150, 2016.

19. Leung SCY, NielsenTO, ZabagloL, Arun I, Badve SS, Bane AL, Bartlett JMS, Borgquist S, Chang MC, Dodson A, Enos RA, Fineberg S, Focke CM, Gao D, Gown AM, Grabau D, Gutierrez C, Hugh JC, Kos Z, Lænkholm A-V, Lin M-G, Mastropasqua MG, Moriya T, Nofech-Mozes S, Osborne CK, Penault-Llorca FM, Piper T, Sakatani T, Salgado R, Starczynski J, Viale G, Hayes DF, McShane LM, Dowsett M and on behalf of the International Ki67 in Breast Cancer Working Group of the Breast 12 International Group and North American Breast Cancer Group (BIG-NABCG). Analytical validation of a standardized scoring protocol for Ki67: phase 3 of an international multicenter collaboration. NPJ Breast Cancer 2: 16014, 2016. [doi:10.1038/npjbcancer.2016.14]

20. O.Connor JPB, Aboagye EO, Adams JE, Aerts HJWL, Barrington SF, Beer AJ, Boellaard R, Bohndiek SE, Brown G, Brady M, Buckley DL, Chenevert TL, Clarke LP, Collette S, Cook GJ, deSouza NM, Dickson JC, Dive C, Evelhoch JL, Faivre-Finn C, Gallagher FA, Gilbert FJ, Gillies RJ, Goh V, Griffiths JR, Groves AM, Halligan S, Harris AL, Hawkes DJ, Hoekstra OS, Huang EP, Hutton BF, Jackson EF, Jayson GC, Jones A, Koh D-M, Lacombe D, Lambin P, Lassau N, Leach MO, Lee T-Y, Leen EL, Lewis JS, Liu Y, Lythgoe MF, Manoharan P, Maxwell RJ, Miles KA, Morgan B, Morris S, Ng T, Padhani AR, Parker GJM, Partridge M, Pathak AP, Peet AC, Punwani S, Reynolds AR, Robinson SP, Shankar LK, Sharma RA, Soloviev D, Stroobants S, Sullivan DC, Taylor SA, Tofts PS, Tozer GM, van Herk M, Walker-Samuel S, Wason J, Williams KJ, Workman P, Yankeelov TE, Brindle KM, McShane LM, Jackson A, Waterton JC. Imaging biomarker roadmap for cancer studies. Nature Reviews Clinical Oncology 14: 169-186, 2016. [doi:10.1038/nrclinonc.2016.162].

21. Sachs MC, McShane LM. Issues in developing multivariable molecular signatures for guiding clinical care decisions. Journal of Biopharmaceutical Statistics 26(6): 1098-1110, 2016.

22. Lih C-J, Harrington RD, Sims DJ, Harper KN, Bouk CH, Datta V, Yau J, Singh RR, Routbort MJ, Luthra R, Patel KP, Mantha GS, Krishnamurthy S, Ronski K, Walther Z, Finberg KE, Canosa S, Robinson H, Raymond A, Le LP, McShane LM, Polley EC, Conley BA, Doroshow JH, Iafrate AJ, Sklar JL, Hamilton SR, Williams PM. Analytical validation of the next generation sequencing assay for a nationwide signal-finding clinical trial: Molecular Analysis for Therapy CHoice clinical trial (NCI-MATCH, EAY131). Journal of Molecular Diagnostics 19(2): 313-327, 2017.

Selected Recent Books and Book Chapters (within last 5 years):

1. McShane LM, Korn EL, Freidlin B. Statistical considerations in the development and evaluation of therapeutic biomarkers in cancer. pp. 31-58 in Handbook of Therapeutic Biomarkers in Cancer, Yang, Dancey (eds.), Pan Stanford, Singapore, 2013.

2. Altman DG, McShane LM, Sauerbrei W, Taube SE, Cavenagh MM. REMARK: REporting recommendations for tumour MARKer prognostic studies. In Guidelines for Reporting Health Research: A User's Manual, Altman, Schulz, Simera, Wager (eds), Wiley, 2014.

3. McShane LM, Hunsberger S. An overview of phase II clinical trial designs with biomarkers. pp. 71-87 in Design and Analysis of Clinical Trials for Predictive Medicine, Matsui, Buyse, Simon (eds.), Chapman and Hall/CRC, 2015.

4. Sachs MC, McShane LM. Development and validation of predictive signatures. pp. 133-165 in Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis, George, Wang, Pang (eds.), CRC Press, Boca Raton, FL, 2016.

5. McShane LM, Lively TG, Makhlouf HR. Translation of biomarkers into clinical practice. pp. 1-18 in Molecular Pathology of Breast Cancer, Badve, Gökmen-Polar (eds.), Springer International Publishing, Switzerland, 2016.

Dr. Lisa Meier McShane

Office Address:
Room 5W130
9609 Medical Center Dr
Rockville, MD 20850

Contact Information:
Tel: (240) 276-6037
Fax: (240) 276-7888