Publications by authors named "Sumithra J Mandrekar"

100Publications

Guidelines for Statistical Reporting in Medical Journals.

J Thorac Oncol 2020 Aug 25. Epub 2020 Aug 25.

Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.

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http://dx.doi.org/10.1016/j.jtho.2020.08.019DOI Listing
August 2020

Introducing the Journal of Thoracic Oncology Statistical Series.

J Thorac Oncol 2020 Aug;15(8):1257

Department of Oncology, Mayo Clinic, Rochester, Minnesota. Electronic address:

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http://dx.doi.org/10.1016/j.jtho.2020.05.017DOI Listing
August 2020

Clinical Versus Statistical Significance in Studies of Thoracic Malignancies.

J Thorac Oncol 2020 Sep 21;15(9):1406-1408. Epub 2020 Jun 21.

Mayo Clinic, Rochester, Minnesota.

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http://dx.doi.org/10.1016/j.jtho.2020.06.007DOI Listing
September 2020

Neoadjuvant Immunotherapy for NSCLC: Current Concepts and Future Approaches.

J Thorac Oncol 2020 Aug 6;15(8):1281-1297. Epub 2020 Jun 6.

Department of Oncology, Mayo Clinic, Rochester, Minnesota. Electronic address:

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http://dx.doi.org/10.1016/j.jtho.2020.05.020DOI Listing
August 2020

Principles of Good Clinical Trial Design.

J Thorac Oncol 2020 Aug 15;15(8):1277-1280. Epub 2020 May 15.

Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.

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http://dx.doi.org/10.1016/j.jtho.2020.05.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7390662PMC
August 2020

Understanding Verbosity: Funding Source and the Length of Consent Forms for Cancer Clinical Trials.

J Cancer Educ 2020 May 8. Epub 2020 May 8.

Section of Cancer Center Biostatistics, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.

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http://dx.doi.org/10.1007/s13187-020-01757-7DOI Listing
May 2020

Missing tumor measurement (TM) data in the search for alternative TM-based endpoints in cancer clinical trials.

Contemp Clin Trials Commun 2020 Mar 22;17:100492. Epub 2019 Nov 22.

Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.

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http://dx.doi.org/10.1016/j.conctc.2019.100492DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6909186PMC
March 2020

Physician-Reported Experience and Understanding of Adverse Event Attribution in Cancer Clinical Trials.

Mayo Clin Proc Innov Qual Outcomes 2019 Jun 27;3(2):176-182. Epub 2019 May 27.

Department of Health Sciences Research, Mayo Clinic, Rochester, MN.

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http://dx.doi.org/10.1016/j.mayocpiqo.2019.01.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6543498PMC
June 2019

Ibrutinib Regimens in Older Patients with Untreated CLL. Reply.

N Engl J Med 2019 04;380(17):1680-1681

Mayo Clinic, Rochester, MN.

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http://dx.doi.org/10.1056/NEJMc1901284DOI Listing
April 2019

Ibrutinib Regimens versus Chemoimmunotherapy in Older Patients with Untreated CLL.

N Engl J Med 2018 12 1;379(26):2517-2528. Epub 2018 Dec 1.

From Ohio State University Comprehensive Cancer Center, Columbus (J.A.W., A.S.R., N.A.H., W.Z., K.A.R., G.L., J.S.B., H.G.O., J.C.B.); the Alliance Statistics and Data Center (A.S.R., A.M.B., B.M.-E., B.F., S.J.M.), Mayo Clinic (W.D., S.A.P., M.L.), Rochester, MN; Washington University School of Medicine, St. Louis (N.L.B.); Duke Cancer Institute, Duke University Medical Center, Durham (D.M.B., H.E.), and First Health of the Carolinas Cancer Center, Pinehurst (C.K.) - both in North Carolina; the University of Rochester Medical Center, Rochester, NY (P.M.B.); Stanford University School of Medicine, Stanford (S.C.), and the City of Hope Comprehensive Cancer Center, Duarte (A.H.) - both in California; Dana-Farber Partners CancerCare (J.R.B., R.M.S.) and the Massachusetts General Hospital Cancer Center (J.S.A.) - both in Boston; Fort Wayne Medical Oncology and Hematology, Fort Wayne, IN (S.N.); University of Chicago Comprehensive Cancer Center (R.A.L.) and Loyola University Chicago (S.E.S.) - both in Chicago; the University of Calgary, Tom Baker Cancer Centre, Calgary, AB, Canada (C.O.); and the Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (R.F.L.).

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http://dx.doi.org/10.1056/NEJMoa1812836DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6325637PMC
December 2018

Biomarker Clinical Trials in Lung Cancer: Design, Logistics, Challenges, and Practical Considerations.

J Thorac Oncol 2018 11 4;13(11):1625-1637. Epub 2018 Sep 4.

Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota. Electronic address:

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http://dx.doi.org/10.1016/j.jtho.2018.08.2019DOI Listing
November 2018

Application of multi-state models in cancer clinical trials.

Clin Trials 2018 10 23;15(5):489-498. Epub 2018 Jul 23.

1 Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.

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http://dx.doi.org/10.1177/1740774518789098DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6133743PMC
October 2018

Evaluation of End Points in Cancer Clinical Trials.

J Thorac Oncol 2018 06 26;13(6):745-747. Epub 2018 Apr 26.

Mayo Clinic, Rochester, Minnesota.

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http://dx.doi.org/10.1016/j.jtho.2018.04.004DOI Listing
June 2018

Definitions and statistical properties of master protocols for personalized medicine in oncology.

J Biopharm Stat 2018 9;28(2):217-228. Epub 2017 Oct 9.

a Division of Biomedical Statistics and Informatics , Mayo Clinic , Rochester , MN , USA.

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http://dx.doi.org/10.1080/10543406.2017.1372778DOI Listing
July 2019

Repeated measures dose-finding design with time-trend detection in the presence of correlated toxicity data.

Clin Trials 2017 Dec 2;14(6):611-620. Epub 2017 Aug 2.

1 Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.

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http://dx.doi.org/10.1177/1740774517723829DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5714674PMC
December 2017

Midostaurin plus Chemotherapy for Acute Myeloid Leukemia with a FLT3 Mutation.

N Engl J Med 2017 08 23;377(5):454-464. Epub 2017 Jun 23.

From the Department of Medical Oncology, Dana-Farber Cancer Institute, Boston (R.M.S.); the Division of Biomedical Statistics and Informatics (S.J.M., K.L.) and the Alliance Statistics and Data Center (S.J.M., K.L., S.G.), Mayo Clinic, Rochester, MN; the Alliance Statistics and Data Center, Duke University, Durham, NC (B.L.S.); the Ohio State University Comprehensive Cancer Center, Columbus (S.G., C.D.B., T.W.P., G.M., R.B.K.); Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus der TU Dresden, Dresden (C.T., G.E.), Department of Internal Medicine III, University Hospital of Ulm, Ulm (K.D., R.F.S., H.D.), Hematology and Oncology, University of Leipzig, Leipzig (D.N.), Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover (J.K., A.G.), and Department of Medicine II, Hematology-Oncology, Goethe University Hospital Frankfurt, Frankfurt am Main (H.S.) - all in Germany; the Department of Biomedicine and Prevention, University Tor Vergata, Rome (F.L.-C., S.A.); the Department of Clinical Haematology, Alfred Hospital and Monash University, Melbourne, VIC, Australia (A.W.); Hospital de la Santa Creu i Sant Pau, Hematology Department, Autonomous University of Barcelona, Barcelona (J.S.), and Hospital Universitario la Fe, Hematology Department, Department of Medicine, University of Valencia, Valencia (M.A.S.) - both in Spain; the Department of Medical Oncology and Hematology, Princess Margaret Hospital, Toronto (J.M.B.); Radboud Institute Molecular Studies, Radboud University Medical Center, Nijmegen, the Netherlands (T.W.); the Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle (F.R.A.); the Division of Hematology-Oncology, Stanford Comprehensive Cancer Center, Stanford University, Stanford, CA (B.C.M.); the Leukemia Service, Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (M.S.T.); and the Department of Medicine, University of Chicago, Chicago (R.A.L.).

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http://dx.doi.org/10.1056/NEJMoa1614359DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5754190PMC
August 2017

Keyboard: A Novel Bayesian Toxicity Probability Interval Design for Phase I Clinical Trials.

Clin Cancer Res 2017 Aug 25;23(15):3994-4003. Epub 2017 May 25.

The University of Texas MD Anderson Cancer Center, Houston, Texas.

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http://dx.doi.org/10.1158/1078-0432.CCR-17-0220DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5554436PMC
August 2017

Daniel J. Sargent, 1970-2016.

Clin Trials 2016 12;13(6):677-679

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http://dx.doi.org/10.1177/1740774516678810DOI Listing
December 2016

Time to progression ratio: promising new metric or just another metric?

Ann Transl Med 2016 Oct;4(Suppl 1):S43

Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.

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http://dx.doi.org/10.21037/atm.2016.10.21DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5104653PMC
October 2016

Enrollment Trends and Disparity Among Patients With Lung Cancer in National Clinical Trials, 1990 to 2012.

J Clin Oncol 2016 11 30;34(33):3992-3999. Epub 2016 Sep 30.

Herbert H. Pang and Perry Cheng, School of Public Health, Li Ka Shing Faculty of Medicine, Hong Kong, Special Administrative Region, People's Republic of China; Herbert H. Pang, Xiaofei Wang, Ying Zhang, Thomas E. Stinchcombe, and Harvey J. Cohen, Duke University School of Medicine, Durham, NC; Melisa L. Wong, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco; David Gandara, University of California, Davis Comprehensive Cancer Center, Sacramento, CA; Apar Kishor Ganti, Veterans Affairs Nebraska Western Iowa Health Care System and University of Nebraska Medical Center, Omaha, NE; Daniel J. Sargent and Sumithra J. Mandrekar, Mayo Clinic, Rochester, MN; Chen Hu, NRG Oncology Statistics and Data Management Center, Philadelphia, PA; Chen Hu, Johns Hopkins University School of Medicine, Baltimore, MD; Mary W. Redman, Fred Hutchinson Cancer Research Center, Seattle, WA; Judith B. Manola, Dana-Farber Cancer Institute, Boston, MA; Richard L. Schilsky, ASCO, Alexandria, VA; Jeffrey D. Bradley, Washington University School of Medicine, St Louis, MO; Alex A. Adjei, Roswell Park Cancer Institute, Buffalo, NY; Suresh S. Ramalingam, The Winship Cancer Institute of Emory University, Atlanta, GA; and Everett E. Vokes, University of Chicago, Chicago, IL.

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http://dx.doi.org/10.1200/JCO.2016.67.7088DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5477832PMC
November 2016

A Bayesian dose-finding design incorporating toxicity data from multiple treatment cycles.

Stat Med 2017 01 15;36(1):67-80. Epub 2016 Sep 15.

Department of Health Sciences Research, Mayo Clinic, 55905, Rochester, MN, U.S.A.

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http://dx.doi.org/10.1002/sim.7134DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5138146PMC
January 2017

Precision oncology: A new era of cancer clinical trials.

Cancer Lett 2017 02 14;387:121-126. Epub 2016 Mar 14.

Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA.

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https://linkinghub.elsevier.com/retrieve/pii/S03043835163016
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http://dx.doi.org/10.1016/j.canlet.2016.03.015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5023449PMC
February 2017

Clinical trial designs incorporating predictive biomarkers.

Cancer Treat Rev 2016 Feb 5;43:74-82. Epub 2016 Jan 5.

Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA.

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http://dx.doi.org/10.1016/j.ctrv.2015.12.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4737867PMC
February 2016

Clinical Utility of Metrics Based on Tumor Measurements in Phase II Trials to Predict Overall Survival Outcomes in Phase III Trials by Using Resampling Methods.

J Clin Oncol 2015 Dec 26;33(34):4048-57. Epub 2015 Oct 26.

Ming-Wen An, Vassar College, Poughkeepsie, NY; Yu Han, Novartis Pharmaceuticals, East Hanover NJ; Jeffrey Meyers, Daniel J. Sargent, and Sumithra J. Mandrekar, Mayo Clinic, Rochester, MN; and Jan Bogaerts, European Organisation for Research and Treatment of Cancer, Brussels, Belgium.

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http://dx.doi.org/10.1200/JCO.2015.60.8778DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4669590PMC
December 2015

Designing a definitive trial for adjuvant targeted therapy in genotype defined lung cancer: the ALCHEMIST trials.

Chin Clin Oncol 2015 Sep;4(3):37

Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.

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http://dx.doi.org/10.3978/j.issn.2304-3865.2015.09.03DOI Listing
September 2015

Molecular and clinical implementations of ovarian cancer mouse avatar models.

Chin Clin Oncol 2015 Sep;4(3):30

Division of Medical Oncology, Mayo Clinic College of Medicine, 200 First St. SW, Rochester, MN 55905, USA.

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http://dx.doi.org/10.3978/j.issn.2304-3865.2015.04.01DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4750944PMC
September 2015

Evaluating Continuous Tumor Measurement-Based Metrics as Phase II Endpoints for Predicting Overall Survival.

J Natl Cancer Inst 2015 Nov 21;107(11). Epub 2015 Aug 21.

Department of Mathematics, Vassar College, Poughkeepsie, NY (MWA); Department of Biostatistics, Analytical Science, Takeda Pharmaceuticals, Deerfield, IL (XD); Department of Health Sciences Research, Mayo Clinic, Rochester, MN (JM, DJS, SJM); Biometrics and Data Management Department, Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Department of Oncology, Mayo Clinic, Rochester, MN (AG); European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium (JB).

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http://jnci.oxfordjournals.org/content/107/11/djv239.full.pd
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http://jnci.oxfordjournals.org/lookup/doi/10.1093/jnci/djv23
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http://dx.doi.org/10.1093/jnci/djv239DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4643633PMC
November 2015

Multitrial Evaluation of Progression-Free Survival as a Surrogate End Point for Overall Survival in First-Line Extensive-Stage Small-Cell Lung Cancer.

J Thorac Oncol 2015 Jul;10(7):1099-106

*Division of Biomedical Statistics and Informatics, Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota; †Department of Radiation Oncology, Mayo Clinic, Scottsdale, Arizona; ‡Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, Washington; §Department of Biostatistics and Bioinformatics, Alliance Statistics and Data Center, Duke University, Durham, North Carolina; ‖Department of Biostatistics & Computational Biology, Dana-Farber Cancer Institute, Boston, Massachusetts; ¶Department of Oncology, NCIC Clinical Trials Group, Queen' University, Kingston, ON, Canada; #Department of Hematology & Oncology, Winship Cancer Institute, Emory University, Atlanta, Georgia; **Division of Hematology and Oncology, UC Davis Comprehensive Cancer Center, Sacramento, California; ††Department of Statistics for the Data Center/Operations Office, Japan Clinical Oncology Group Data Center, Center for Research Administration and Support, National Cancer Center, Tokyo, Japan; ‡‡Department of Medical Oncology, Japanese Society of Medical Oncology, Tokyo, Japan; §§Department of Medicine, The University of Chicago Medicine and Biologic Sciences Center, Chicago, Illinois; and ‖‖Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York.

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https://linkinghub.elsevier.com/retrieve/pii/S15560864153349
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http://dx.doi.org/10.1097/JTO.0000000000000548DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4493926PMC
July 2015

Improving Clinical Trial Efficiency: Thinking outside the Box.

Am Soc Clin Oncol Educ Book 2015 :e141-7

From the Mayo Clinic, Rochester, MN; Dana-Farber Cancer Institute, Boston, MA; National Institutes of Health, Rockville, MD.

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http://dx.doi.org/10.14694/EdBook_AM.2015.35.e141DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6995119PMC
February 2016

Drug designs fulfilling the requirements of clinical trials aiming at personalizing medicine.

Chin Clin Oncol 2014 Jun;3(2):14

Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN 55905, USA.

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http://dx.doi.org/10.3978/j.issn.2304-3865.2014.05.03DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4236025PMC
June 2014

A phase I/II study of bortezomib in combination with paclitaxel, carboplatin, and concurrent thoracic radiation therapy for non-small-cell lung cancer: North Central Cancer Treatment Group (NCCTG)-N0321.

J Thorac Oncol 2015 Jan;10(1):172-80

*Department of Medicine, Roswell Park Cancer Institute, Buffalo, NY; †Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN; ‡Illinois CancerCare, Peoria, IL; §Hematology/Oncology and **Radiation Oncology, Mayo Clinic, Scottsdale, AZ; ‖Carle Cancer Center Community Clinical Oncology Program, Urbana, IL; ¶Wichita Community Clinical Oncology Program, Wichita, KS; #Oncology and ‡‡Laboratory Medicine and Pathology, and Anatomic Pathology, Mayo Clinic, Rochester, MN; and ††Upstate Carolina CCOP, Spartanburg, SC.

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http://dx.doi.org/10.1097/JTO.0000000000000383DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4320011PMC
January 2015

Impact of brachytherapy on local recurrence rates after sublobar resection: results from ACOSOG Z4032 (Alliance), a phase III randomized trial for high-risk operable non-small-cell lung cancer.

J Clin Oncol 2014 Aug 30;32(23):2456-62. Epub 2014 Jun 30.

Hiran C. Fernando, Boston Medical Center, Boston, MA; Rodney J. Landreneau, Dwight E. Heron, and Benedict D.T. Daly, University of Pittsburgh, Pittsburgh, PA; Sumithra J. Mandrekar, Francis C. Nichols, Shauna L. Hillman, and Angelina D. Tan, Mayo Clinic, Rochester, MN; Bryan F. Meyers, Washington University of St Louis, St Louis, MO; Thomas A. DiPetrillo, Rhode Island Hospital, Providence, RI; David R. Jones, University of Virginia, Charlottesville, VA; Sandra L. Starnes, University of Cincinnati, Cincinnati, OH; and Joe B. Putnam Jr, Vanderbilt University Medical Center, Nashville, TN.

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http://ascopubs.org/doi/10.1200/JCO.2013.53.4115
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http://dx.doi.org/10.1200/JCO.2013.53.4115DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4121503PMC
August 2014

Multipopulation Tailoring Clinical Trials: Design, Analysis, and Inference Considerations.

Ther Innov Regul Sci 2014 Jul;48(4):453-462

1 Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.

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http://dx.doi.org/10.1177/2168479013519630DOI Listing
July 2014

Early phase trial designs and endpoints for targeted therapies in rare genotype subsets.

Am Soc Clin Oncol Educ Book 2014 :e107-10

From the Department of Health Sciences Research, Mayo Clinic, Rochester, MN.

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http://dx.doi.org/10.14694/EdBook_AM.2014.34.e107DOI Listing
December 2015

Evaluation of alternate categorical tumor metrics and cut points for response categorization using the RECIST 1.1 data warehouse.

J Clin Oncol 2014 Mar 10;32(8):841-50. Epub 2014 Feb 10.

Sumithra J. Mandrekar, Jeffrey Meyers, Axel Grothey, and Daniel J. Sargent, Mayo Clinic, Rochester, MN; Ming-Wen An, Vassar College, Poughkeepsie, NY; and Jan Bogaerts, European Organisation for Research and Treatment of Cancer, Brussels, Belgium.

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http://ascopubs.org/doi/10.1200/JCO.2013.52.3019
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http://dx.doi.org/10.1200/JCO.2013.52.3019DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3940541PMC
March 2014

Dose-finding trial designs for combination therapies in oncology.

J Clin Oncol 2014 Jan 9;32(2):65-7. Epub 2013 Dec 9.

Mayo Clinic, Rochester, MN.

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http://dx.doi.org/10.1200/JCO.2013.52.9198DOI Listing
January 2014

Application of tumor measurement-based metrics in the real world.

J Clin Oncol 2013 Dec 28;31(34):4374. Epub 2013 Oct 28.

Vassar College, Poughkeepsie, NY.

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http://dx.doi.org/10.1200/JCO.2013.52.3662DOI Listing
December 2013

Statistical issues in the validation of prognostic, predictive, and surrogate biomarkers.

Clin Trials 2013 Oct 27;10(5):647-52. Epub 2013 Aug 27.

Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA.

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http://dx.doi.org/10.1177/1740774513497125DOI Listing
October 2013

Missing data and measurement variability in assessing progression-free survival endpoint in randomized clinical trials.

Clin Cancer Res 2013 May;19(10):2613-20

CDER/OTS/OB/DBV, U.S. Food and Drug Administration, Silver Spring, Maryland 20993, USA.

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http://dx.doi.org/10.1158/1078-0432.CCR-12-2938DOI Listing
May 2013

A review of phase II trial designs for initial marker validation.

Contemp Clin Trials 2013 Nov 8;36(2):597-604. Epub 2013 May 8.

Department of Health Sciences Research, Mayo Clinic, Rochester, MN, United States. Electronic address:

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http://dx.doi.org/10.1016/j.cct.2013.05.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3779487PMC
November 2013

Dose-finding designs using a novel quasi-continuous endpoint for multiple toxicities.

Stat Med 2013 Jul 21;32(16):2728-46. Epub 2013 Jan 21.

Biostatistics Department, Institut Gustave-Roussy, Villejuif, France.

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http://dx.doi.org/10.1002/sim.5737DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3813987PMC
July 2013

A 2-stage phase II design with direct assignment option in stage II for initial marker validation.

Clin Cancer Res 2012 Aug 14;18(16):4225-33. Epub 2012 Jun 14.

Department of Mathematics, Vassar College, Poughkeepsie, New York, NY, USA.

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http://dx.doi.org/10.1158/1078-0432.CCR-12-0686DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3421043PMC
August 2012

Impact of disease progression date determination on progression-free survival estimates in advanced lung cancer.

Cancer 2012 Nov 20;118(21):5358-65. Epub 2012 Mar 20.

Department of Health Sciences Research, Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN 55905, USA.

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http://dx.doi.org/10.1002/cncr.27528DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3481159PMC
November 2012

Design of clinical trials for biomarker research in oncology.

Clin Investig (Lond) 2011 Dec;1(12):1629-1636

Division of Biomedical Statistics & Informatics, Mayo Clinic, Rochester, MN 55905, USA.

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http://dx.doi.org/10.4155/CLI.11.152DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3290127PMC
December 2011

Effect of cigarette smoking on quality of life in small cell lung cancer patients.

Eur J Cancer 2012 Jul 12;48(11):1593-601. Epub 2012 Jan 12.

Department of Medical Oncology, The Second Affiliated Hospital, Dalian Medical University, 467 Zhongshan Road, Shahekou District, Dalian 116023, PR China.

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http://dx.doi.org/10.1016/j.ejca.2011.12.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3404819PMC
July 2012

Predictive biomarkers in colorectal cancer: usage, validation, and design in clinical trials.

Scand J Gastroenterol 2012 Mar 19;47(3):356-62. Epub 2011 Dec 19.

Department of Health Science Research, Mayo Clinic, Rochester, MN 55905, USA.

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http://www.tandfonline.com/doi/full/10.3109/00365521.2012.64
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http://dx.doi.org/10.3109/00365521.2012.640836DOI Listing
March 2012

Systematic reviews and meta-analysis of published studies: an overview and best practices.

J Thorac Oncol 2011 Aug;6(8):1301-3

Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota 55905, USA.

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http://dx.doi.org/10.1097/JTO.0b013e31822461b0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3158384PMC
August 2011

All-comers versus enrichment design strategy in phase II trials.

J Thorac Oncol 2011 Apr;6(4):658-60

Department of Health Sciences Research, Mayo Clinic, Rochester, MN 55905, USA.

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http://dx.doi.org/10.1097/JTO.0b013e31820e17cbDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3082391PMC
April 2011

Hierarchical commensurate and power prior models for adaptive incorporation of historical information in clinical trials.

Biometrics 2011 Sep 1;67(3):1047-56. Epub 2011 Mar 1.

Department of Biostatistics, M.D. Anderson Cancer Center, Houston, Texas 77030, USA.

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http://dx.doi.org/10.1111/j.1541-0420.2011.01564.xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3134568PMC
September 2011

Alpha1-antitrypsin deficiency carriers, serum alpha 1-antitrypsin concentration, and non-small cell lung cancer survival.

J Thorac Oncol 2011 Feb;6(2):291-5

Department of Respiratory Medicine, Jinling Hospital, Nanjing University School of Medicine, Nanjing, People's Republic of China.

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http://dx.doi.org/10.1097/JTO.0b013e31820213fbDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3927968PMC
February 2011

Idiopathic systemic capillary leak syndrome (Clarkson's disease): the Mayo clinic experience.

Mayo Clin Proc 2010 Oct 15;85(10):905-12. Epub 2010 Jul 15.

Division of Hematology, Mayo Clinic, 200 First St SW, Rochester, MN 55905, USA.

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http://dx.doi.org/10.4065/mcp.2010.0159DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2947962PMC
October 2010

Randomized phase II trials: time for a new era in clinical trial design.

J Thorac Oncol 2010 Jul;5(7):932-4

Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota 55905, USA.

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http://dx.doi.org/10.1097/JTO.0b013e3181e2eadfDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2941394PMC
July 2010

Predictive biomarker validation in practice: lessons from real trials.

Clin Trials 2010 Oct 14;7(5):567-73. Epub 2010 Apr 14.

Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN 55905, USA.

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http://dx.doi.org/10.1177/1740774510368574DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3913192PMC
October 2010

Biostatistics: a toolkit for exploration, validation, and interpretation of clinical data.

J Thorac Oncol 2009 Dec;4(12):1447-9

Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota 55905, USA.

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http://dx.doi.org/10.1097/JTO.0b013e3181c0a329DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2796575PMC
December 2009

Endpoints in phase II trials for advanced non-small cell lung cancer.

J Thorac Oncol 2010 Jan;5(1):3-9

Department of Health Sciences Research, Division of Biomedical Statistics and Informatics, Mayo Clinic Rochester, Rochester, Minnesota 55905, USA.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2798014PMC
January 2010

Genomic advances and their impact on clinical trial design.

Genome Med 2009 Jul 13;1(7):69. Epub 2009 Jul 13.

Department of Health Sciences Research, Mayo Clinic, Rochester, MN 55905, USA.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2717395PMC
http://dx.doi.org/10.1186/gm69DOI Listing
July 2009

Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges.

J Clin Oncol 2009 Aug 13;27(24):4027-34. Epub 2009 Jul 13.

Department of Health Sciences Research, Mayo Clinic, Rochester, MN 55905, USA.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2734400PMC
August 2009

Clinical trial designs for predictive biomarker validation: one size does not fit all.

J Biopharm Stat 2009 ;19(3):530-42

Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota 55905, USA.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2931323PMC
July 2009