• Researcher Profile

    Richard D. Gelber, PhD

    Richard D. Gelber, PhD
    Professor of Pediatrics (Biostatistics), Harvard Medical School
    Professor of Biostatistics, Harvard T.H. Chan School of Public Health

    Office phone: 617-632-3603
    Fax: 617-632-2444
    Email: gelber@jimmy.harvard.edu

    Preferred contact method: office phone

    Research Department

    Biostatistics and Computational Biology

    Area of Research

    Q-TWiST, Quality-Adjusted Survival, Subpopulation Treatment Effect Pattern Plot (STEPP) and Breast Cancer Clinical Trials

    Dana-Farber Cancer Institute
    450 Brookline Avenue
    CLS 11072
    Boston, MA 02215


    Dr. Gelber received his PhD in operations research (major field: applied probability and statistics) from Cornell University in 1975. He has been at DFCI since 1977 and served as coordinating statistician for the DFCI Pediatric Acute Lymphoblastic Leukemia Consortium from 1977 to 2006 and statistical director of the Pediatric AIDS Clinical Trials Group from 1988 to 1998. He has been the Statistical Director for the International Breast Cancer Study Group since 1978.  In 1993, he was elected a fellow of the American Statistical Association. In addition, he was awarded an Honorary Doctorate in Medicine, University of Göteborg, Sweden in 1997.

    Recent Awards

    • ECCO (European CanCer Organisation) Clinical Research Award, 2011
    • St. Gallen Conference Breast Cancer Award, 2009
    • Susan G. Komen Foundation Brinker Award for Scientific Distinction in Clinical Research, 2008
    • Jacqueline Seroussi Memorial Foundation for Cancer Research Award, 2005
    • European Institute of Oncology Award for Breast Cancer Research, 2002


    Q-TWiST, Quality-Adjusted Survival, Subpopulation Treatment Effect Pattern Plot (STEPP) and Breast Cancer Clinical Trials

    Dr. Gelber developed the Q-TWiST method (Quality-adjusted Time Without Symptoms of disease and Toxicity of treatment) for incorporating quality-of-life considerations into treatment comparisons. This quality-adjusted survival technique provides a framework to balance the benefits of disease control against the costs of treatment side effects using threshold utility analysis and patient preferences. He also created the STEPP method (Subpopulation Treatment Effect Pattern Plot) which uses data from randomized clinical trials to graphically illustrate the pattern of differences in treatment effectiveness as a function of a covariate of interest. Dr. Gelber has directed the Statistical Center for the International Breast Cancer Study Group (IBCSG) since 1978. This consortium of institutions conducts Phase III clinical trials for adjuvant therapy for breast cancer. In addition, he is the senior biostatistician for two three major studies of adjuvant treatment for HER2-positive breast cancer conducted by the Breast International Group (BIG: the HERA and, ALTTO and APHINITY trials).

    Select Publications

    • Regan MM, Pagani O, Francis PA, Fleming GF, Walley BA, Kammler R, Dell'Orto P, Russo L, Szoke J, Doimi F, Villani L, Pizzolitto S, Öhlschlegel C, Sessa F, Peg Cámara V, Rodríguez Peralto JL, MacGrogan G, Colleoni M, Goldhirsch A, Price KN, Coates AS, Gelber RD, Viale G; SOFT and TEXT Investigators and International Breast Cancer Study Group. Predictive value and clinical utility of centrally assessed ER, PgR, and Ki-67 to select adjuvant endocrine therapy for premenopausal women with hormone receptor-positive, HER2-negative early breast cancer: TEXT and SOFT trials. Breast Cancer Res Treat. 2015 Nov;154(2):275-86.
    • Francis PA, Regan MM, Fleming GF, Láng I, Ciruelos E, Bellet M, Bonnefoi HR, Climent MA, Da Prada GA, Burstein HJ, Martino S, Davidson NE, Geyer CE Jr, Walley BA, Coleman R, Kerbrat P, Buchholz S, Ingle JN, Winer EP, Rabaglio-Poretti M, Maibach R, Ruepp B, Giobbie-Hurder A, Price KN, Colleoni M, Viale G, Coates AS, Goldhirsch A, Gelber RD; SOFT Investigators; International Breast Cancer Study Group. Adjuvant ovarian suppression in premenopausal breast cancer. N Engl J Med 2015; 372(5):436-46.
    • Coates AS, Winer EP, Goldhirsch A, Gelber RD, Gnant M, Piccart-Gebhart M, Thürlimann B, Senn H-J & Panel Members. Tailoring therapies-improving the management of early breast cancer: St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2015. Annals Oncol. 2015 Aug;26(8):1533-46.
    • O'Sullivan CC, Bradbury I, Campbell C, Spielmann M, Perez EA, Joensuu H, Costantino JP, Delaloge S, Rastogi P, Zardavas D, Ballman KV, Holmes E, de Azambuja E, Piccart-Gebhart M, Zujewski JA, Gelber RD. Efficacy of adjuvant trastuzumab for patients with human epidermal growth factor receptor 2-positiveearly breast cancer and tumors ≤ 2 cm: a meta-analysis of the randomized trastuzumab trials. J Clin Oncol. 2015 Aug 20;33(24):2600-8.
    • Moore HC, Unger JM, Phillips KA, Boyle F, Hitre E, Porter D, Francis PA, Goldstein LJ, Gomez HL, Vallejos CS, Partridge AH, Dakhil SR, Garcia AA, Gralow J, Lombard JM, Forbes JF, Martino S, Barlow WE, Fabian CJ, Minasian L, Meyskens FL Jr, Gelber RD, Hortobagyi GN, Albain KS; POEMS/S0230 Investigators. Goserelin for ovarian protection during breast-cancer adjuvant chemotherapy. N Engl J Med 2015; 372(10):923-32.
    • Colleoni M, Gray KP, Gelber S, Láng I, Thürlimann B, Gianni L, Abdi EA, Gomez HL, Linderholm BK, Puglisi F, Tondini C, Kralidis E, Eniu A, Cagossi K, Rauch D, Chirgwin J, Gelber RD, Regan MM, Coates AS, Price KN, Viale G, Goldhirsch A. Low-Dose Oral Cyclophosphamide and Methotrexate Maintenance For Hormone Receptor-Negative Early Breast Cancer: International Breast Cancer Study Group Trial 22-00. J Clin Oncol. 2016 Jun 20. pii: JCO656595. [Epub ahead of print]
    • Regan MM, Francis PA, Pagani O, Fleming GF, Walley BA, Viale G, Colleoni M, Láng I, Gómez HL, Tondini C, Pinotti G, Price KN, Coates AS, Goldhirsch A, Gelber RD. Absolute Benefit of Adjuvant Endocrine Therapies for Premenopausal Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer: TEXT and SOFT Trials. J Clin Oncol. 2016 Jul 1;34(19):2221-31.
    • Yip WK, Bonetti M, Cole BF, Barcella W, Wang XV, Lazar A, Gelber RD. Subpopulation Treatment Effect Pattern Plot (STEPP) analysis for continuous, binary, and count outcomes. Clin Trials. 2016 Apr 19. pii: 1740774516643297. [Epub ahead of print]
    • Wang XV, Cole B, Bonetti M, Gelber RD. Meta-STEPP: subpopulation treatment effect pattern plot for individual patient data meta-analysis. Stat Med. 2016 Apr 12. doi: 10.1002/sim.6958. [Epub ahead of print]
    • Colleoni M, Sun Z, Price KN, Karlsson P, Forbes JF, Thürlimann B, Gianni L, Castiglione M, Gelber RD, Coates AS, Goldhirsch A. Annual Hazard Rates of Recurrence for Breast Cancer During 24 Years of Follow-Up: Results From the International Breast Cancer Study Group Trials I to V. J Clin Oncol. 2016 Mar 20;34(9):927-35.
    • Piccart-Gebhart M, Holmes E, Baselga J, deAzambuja E, Dueck AC, Viale G, Zujewski JA, Goldhirsch A, Armour A, Pritchard KI, McCullough AE, Dolci S, McFadden E, Holmes AP, Tonghua L, Eidtmann H, Dinh P, Di Cosimo S, Harbeck N, Tjulandin S, Im Y-H, Huang C-S, Diéras V, Hillman DW, Wolff AC, Jackisch C, Lang I, Untch M, Smith I, Boyle F, Xu B, Gomez H, Suter, Gelber RD, Perez EA. Adjuvant lapatinib and trastuzumab for early human epidermal growth factor receptor 2-positive breast cancer: results from the randomized phase III adjuvant lapatinib and/or trastuzumab treatment optimization trial. J Clin Oncol. 2016 Apr 1;34(10):1034-42.
    • Lazar AA, Bonetti M, Cole BF, Yip WK, Gelber RD. Identifying treatment effect heterogeneity in clinical trials using subpopulations of events: STEPP. Clin Trials. 2016 Apr;13(2):169-79.
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