David L DeMets

David L DeMets

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David L DeMets

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ASPIRIN IN PRIMARY PREVENTION: NEEDS INDIVIDUAL JUDGMENTS.

Am J Med 2020 Feb 1. Epub 2020 Feb 1.

First Sir Richard Doll Professor & Senior Academic Advisor to the Dean, Charles E. Schmidt College of Medicine, Florida Atlantic University, 2800 S. Ocean Blvd. PHA, Boca Raton, FL 33432, USA. Electronic address:

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http://dx.doi.org/10.1016/j.amjmed.2020.01.006DOI Listing
February 2020

Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction.

N Engl J Med 2019 11 19;381(21):1995-2008. Epub 2019 Sep 19.

From the BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M., M.C.P., K.F.D., P.S.J.); the Cardiovascular Division (S.D.S., A.S.D.) and the TIMI Study Group, Brigham and Women's Hospital and Harvard Medical School (M.S.S.) - all in Boston; Section of Endocrinology, Yale University School of Medicine, New Haven, CT (S.E.I.); Rigshospitalet Copenhagen University Hospital (L.K.) and the Department of Cardiology, Gentofte University Hospital (M. Schou), Copenhagen; the Department of Medicine, Saarland University Hospital, Homburg-Saar, Germany (M.B.); Saint Luke's Mid America Heart Institute, University of Missouri, Kansas City (M.N.K.); National University of Cordoba, Cordoba (F.A.M.), and the Division of Cardiology, Instituto Cardiovascular de Buenos Aires, Buenos Aires (M.D.) - both in Argentina; Wroclaw Medical University, Wroclaw (P.P.), and the Department of Cardiology, Medical University of Lodz, Lodz (J.D.) - both in Poland; the Department of Cardiology, University of Minnesota, Minneapolis (I.S.A.); 2nd Department of Internal Medicine, Cardiovascular Medicine, General Teaching Hospital and 1st Faculty of Medicine, Charles University, Prague, Czech Republic (J.B.); the Division of Cardiology, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan (C.-E.C.); the Department of Cardiology, Medanta, Gurgaon, India (V.K.C.); the Department of Cardiology, University Medical Center and University of Groningen, Groningen, the Netherlands (R.A.B.); the 5th Department of Internal Medicine, Comenius University in Bratislava, Bratislava, Slovakia (A.D.); the Department of Cardiology, Shanghai Institute of Cardiovascular Disease and Zhongshan Hospital Fudan University, Shanghai, China (J.G.); Cumming School of Medicine and Libin Cardiovascular Institute, University of Calgary, Calgary, AB (J.G.H.), the Department of Cardiology, Montreal Heart Institute, Montreal (E.O.), and the Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto (S.V.) - all in Canada; Clinic of Cardiology, National Cardiology Hospital, Sofia, Bulgaria (T.K.); the Cardiovascular Division of Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan (M.K.); the Department of Molecular and Clinical Medicine and Cardiology, Sahlgrenska Academy (C.E.A.L.), and AstraZeneca (O.B., M. Sjöstrand, A.M.L.), Gothenburg, and the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University (C.H.), Uppsala - all in Sweden; the Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Instituto do Coracao, Hospital das Clinicas da Faculdade de Medicina, Universidade de São Paolo, São Paolo (J.C.N.); the Department of Internal Medicine, Tan Tao University, Tan Duc, Vietnam (P.N.V.); the Department of Myocardial Disease and Heart Failure, National Medical Research Center of Cardiology, Moscow (S.T.); and the Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison (D.L.D.).

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http://dx.doi.org/10.1056/NEJMoa1911303DOI Listing
November 2019

Establishing and Maintaining Research Integrity at Academic Institutions: Challenges and Opportunities.

Am J Med 2019 Sep 12. Epub 2019 Sep 12.

Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton. Electronic address:

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http://dx.doi.org/10.1016/j.amjmed.2019.08.036DOI Listing
September 2019

Alternatives to Intention-to-Treat Analyses-Reply.

JAMA 2019 06;321(21):2135

Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, Madison.

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http://dx.doi.org/10.1001/jama.2019.3096DOI Listing
June 2019

Challenges of Non-Intention-to-Treat Analyses.

JAMA 2019 Jan;321(2):145-146

Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, Madison.

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http://dx.doi.org/10.1001/jama.2018.19192DOI Listing
January 2019

Data Monitoring Committees: Current issues.

Clin Trials 2018 08 9;15(4):321-328. Epub 2018 Apr 9.

3 University of Wisconsin-Madison, Madison, WI, USA.

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http://dx.doi.org/10.1177/1740774518764855DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6053319PMC
August 2018

Machine Learning Algorithm Predicts Cardiac Resynchronization Therapy Outcomes: Lessons From the COMPANION Trial.

Circ Arrhythm Electrophysiol 2018 01;11(1):e005499

From the Division of Cardiovascular Medicine, Department of Medicine, School of Medicine and Public Health (M.M.K., R.T.K., M.C.T., M.E.F., L.L.E.), Department of Biostatistics and Medical Informatics (C.M., K.A.B., D.L.D., C.D.P.), University of Wisconsin Institute for Clinical and Translational Research (C.M.), and Department of Computer Sciences (C.D.P.), University of Wisconsin-Madison.

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http://dx.doi.org/10.1161/CIRCEP.117.005499DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5769699PMC
January 2018

Guidelines for Statistical Analysis Plans.

JAMA 2017 12;318(23):2301-2303

Department of Biostatistics and Medical Informatics, School of Medicine and Public Health, University of Wisconsin-Madison.

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http://dx.doi.org/10.1001/jama.2017.18954DOI Listing
December 2017

Institutional Responsibility and the Flawed Genomic Biomarkers at Duke University: A Missed Opportunity for Transparency and Accountability.

Sci Eng Ethics 2017 08 23;23(4):1199-1205. Epub 2016 Nov 23.

School of Medicine, University of North Carolina-Chapel Hill, 101 Manning Dr, Chapel Hill, NC, 27514, USA.

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http://dx.doi.org/10.1007/s11948-016-9844-4DOI Listing
August 2017

Randomized Trial of Plaque-Identifying Toothpaste: Decreasing Plaque and Inflammation.

Am J Med 2017 06 19;130(6):746-749. Epub 2016 Oct 19.

Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton. Electronic address:

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https://linkinghub.elsevier.com/retrieve/pii/S00029343163097
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http://dx.doi.org/10.1016/j.amjmed.2016.09.003DOI Listing
June 2017

Understanding the functions and operations of data monitoring committees: Survey and focus group findings.

Clin Trials 2017 Feb 24;14(1):59-66. Epub 2016 Nov 24.

6 University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.

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http://dx.doi.org/10.1177/1740774516679665DOI Listing
February 2017

Enhancing the Scientific Integrity and Safety of Clinical Trials: Recommendations for Data Monitoring Committees.

JAMA 2016 12;316(22):2359-2360

Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison.

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http://dx.doi.org/10.1001/jama.2016.16070DOI Listing
December 2016

Data Monitoring Committees - Expect the Unexpected.

N Engl J Med 2016 Oct;375(14):1365-1371

From the Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, Madison (D.L.D.); and the Department of Biostatistics and Epidemiology, University of Pennsylvania Perelman School of Medicine, Philadelphia (S.S.E.).

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http://dx.doi.org/10.1056/NEJMra1510066DOI Listing
October 2016

Incentives for Clinical Trialists to Share Data.

N Engl J Med 2016 Sep;375(12):1112-5

From the Greenwall Foundation, New York (B.L.); and the Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison (D.L.D.).

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http://dx.doi.org/10.1056/NEJMp1608351DOI Listing
September 2016

Lessons Learned and Insights Gained in the Design, Analysis, and Outcomes of the COMPANION Trial.

JACC Heart Fail 2016 07 8;4(7):521-535. Epub 2016 Jun 8.

University of Wisconsin, Madison, Wisconsin.

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http://dx.doi.org/10.1016/j.jchf.2016.02.019DOI Listing
July 2016

Enhancing trial integrity by protecting the independence of data monitoring committees in clinical trials.

J Biopharm Stat 2014 ;24(5):968-75

a Department of Biostatistics , University of Washington , Seattle , Washington , USA.

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http://dx.doi.org/10.1080/10543406.2014.925719DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4153744PMC
July 2015

Prevention: Aspirin in primary prevention needs individual judgements.

Nat Rev Cardiol 2014 Aug 24;11(8):438-40. Epub 2014 Jun 24.

University of Wisconsin School of Medicine and Public Health, 600 Highland Avenue, Madison, WI 53792, USA.

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http://dx.doi.org/10.1038/nrcardio.2014.88DOI Listing
August 2014

NHLBI clinical trials workshop: an executive summary.

Stat Med 2012 Nov 26;31(25):2938-43. Epub 2012 Jun 26.

Office of Biostatistics Research, Division of Cardiovascular Sciences, National Heart, Lung and Blood Institute, Bethesda, MD 20892, U.S.A.

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http://dx.doi.org/10.1002/sim.5406DOI Listing
November 2012

Current development in clinical trials: issues old and new.

Authors:
David L DeMets

Stat Med 2012 Nov 27;31(25):2944-54. Epub 2012 Jun 27.

Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, WI, U.S.A.

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http://dx.doi.org/10.1002/sim.5405DOI Listing
November 2012

Commentary on Anand et al.

Authors:
David L DeMets

Clin Trials 2011 Dec;8(6):722-3; discussion 726

Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, Madison, WI 53792-4675, USA.

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http://dx.doi.org/10.1177/1740774511426581DOI Listing
December 2011

A historical perspective on clinical trials innovation and leadership: where have the academics gone?

JAMA 2011 Feb;305(7):713-4

Department of Biostatistics and Medical Informatics, K6/446 Clinical Science Center, 600 Highland Ave, University of Wisconsin-Madison, Madison, WI 53792-4675, USA.

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http://dx.doi.org/10.1001/jama.2011.175DOI Listing
February 2011

Review of draft FDA adaptive design guidance.

J Biopharm Stat 2010 Nov;20(6):1132-42

Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, Madison, Wisconsin, USA.

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http://dx.doi.org/10.1080/10543406.2010.514455DOI Listing
November 2010

Bias and trials stopped early for benefit.

JAMA 2010 Jul;304(2):158; author reply 158-9

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http://dx.doi.org/10.1001/jama.2010.933DOI Listing
July 2010

Some drop-the-loser designs for monitoring multiple doses.

Stat Med 2010 Jul;29(17):1793-807

Merck Research Laboratories, North Wales, PA 19454, USA.

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http://dx.doi.org/10.1002/sim.3958DOI Listing
July 2010

Doing more good than harm: need for a cease fire.

Am J Med 2009 Apr;122(4):315-6

Department of Clinical Science, Florida Atlantic University, Boca Raton, Fla., USA.

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http://dx.doi.org/10.1016/j.amjmed.2008.10.021DOI Listing
April 2009

Futility approaches to interim monitoring by data monitoring committees.

Authors:
David L Demets

Clin Trials 2006 ;3(6):522-9

University of Wisconsin-Madison, Department of Biostatistics and Medical Informatics, Madison, Wisconsin 53792-4675, USA.

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http://dx.doi.org/10.1177/1740774506073115DOI Listing
March 2008

An Institutional Review Board dilemma: responsible for safety monitoring but not in control.

Clin Trials 2006 ;3(2):142-8

Biostatistics and Medical Informatics, University of Wisconsin, 600 Highland Avenue, Box 4675, K6/446 CSC, Madison, WI 53792-4675, USA.

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http://dx.doi.org/10.1191/1740774506cn137oaDOI Listing
January 2007

Training of the next generation of biostatisticians: a call to action in the U.S.

Stat Med 2006 Oct;25(20):3415-29

Department of Biostatistics and Medical Informatics, University of Wisconsin, School of Medicine & Public Health, 600 Highland Avenue, Box 4675, Madison, WI 53792, USA.

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http://dx.doi.org/10.1002/sim.2668DOI Listing
October 2006

Conditional and unconditional confidence intervals following a group sequential test.

J Biopharm Stat 2006 ;16(1):107-22

Merck Research Laboratory, Merck & Co., Inc. West Point, Pennsylvania, USA.

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http://dx.doi.org/10.1080/10543400500406595DOI Listing
September 2006

The independent statistician for data monitoring committees.

Stat Med 2004 May;23(10):1513-7

Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, 600 Highland Avenue, Box 4675, Madison, WI 53792-4675, USA.

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http://dx.doi.org/10.1002/sim.1786DOI Listing
May 2004

Conditional bias of point estimates following a group sequential test.

J Biopharm Stat 2004 May;14(2):505-30

Merck Research Laboratories, Merck & Co., Inc., West Point, Pennsylvania 19486, USA.

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http://dx.doi.org/10.1081/bip-120037195DOI Listing
May 2004

Increasing the sample size when the unblinded interim result is promising.

Stat Med 2004 Apr;23(7):1023-38

Merck Research Laboratories, Blue Bell, PA 19422, USA.

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http://dx.doi.org/10.1002/sim.1688DOI Listing
April 2004

Design and analysis of group sequential clinical trials with multiple primary endpoints.

Biometrics 2004 Mar;60(1):134-45

Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, Wisconsin 53792, USA.

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http://dx.doi.org/10.1111/j.0006-341X.2004.00146.xDOI Listing
March 2004

Toward protecting the safety of participants in clinical trials.

Control Clin Trials 2003 Jun;24(3):256-71

Duke Clinical Research Institute, Duke University Medical Center, PO Box 17969, Durham, NC 27715, USA.

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http://dx.doi.org/10.1016/s0197-2456(03)00005-9DOI Listing
June 2003

Monitoring mortality at interim analyses while testing a composite endpoint at the final analysis.

Control Clin Trials 2003 Feb;24(1):16-27

Merck Research Laboratories, Blue Bell, PA 19422, USA.

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http://dx.doi.org/10.1016/s0197-2456(02)00306-9DOI Listing
February 2003

Her-2/neu overexpression and response to oophorectomy plus tamoxifen adjuvant therapy in estrogen receptor-positive premenopausal women with operable breast cancer.

J Clin Oncol 2003 Feb;21(3):453-7

Departments of Medicine and Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI 53726, USA.

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http://dx.doi.org/10.1200/JCO.2003.10.133DOI Listing
February 2003

Clinical trials in the new millennium.

Authors:
David L DeMets

Stat Med 2002 Oct;21(19):2779-87

Department of Biostatistics, University of Wisconsin-Madison, 600 Highland Avenue, K6/446A CSC, Madison, Wisconsin 53792-4675, USA.

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http://dx.doi.org/10.1002/sim.1281DOI Listing
October 2002

Monitoring clinical trials: issues and controversies regarding confidentiality.

Stat Med 2002 Oct;21(19):2843-51

Department of Biostatistics, University of Washington, Seattle, Washington 98195-7232, USA.

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http://dx.doi.org/10.1002/sim.1288DOI Listing
October 2002

Lessons learned from recent cardiovascular clinical trials: Part I.

Circulation 2002 Aug;106(6):746-51

Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27715, USA.

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http://dx.doi.org/10.1161/01.cir.0000023219.51483.66DOI Listing
August 2002

Lessons learned from recent cardiovascular clinical trials: Part II.

Circulation 2002 Aug;106(7):880-6

Duke Clinical Research Institute and the Division of Cardiology, Duke University Medical Center, Durham, NC 27715, USA.

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http://dx.doi.org/10.1161/01.cir.0000023220.26465.89DOI Listing
August 2002

Principles from clinical trials relevant to clinical practice: Part I.

Circulation 2002 Aug;106(8):1015-21

Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27715, USA.

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http://dx.doi.org/10.1161/01.cir.0000023260.78078.bbDOI Listing
August 2002

Principles from clinical trials relevant to clinical practice: Part II.

Circulation 2002 Aug;106(9):1172-5

Duke Clinical Research Institute and the Division of Cardiology, Duke University Medical Center, Durham, NC, USA.

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http://dx.doi.org/10.1161/01.cir.0000023218.39412.32DOI Listing
August 2002

Mastectomy and oophorectomy by menstrual cycle phase in women with operable breast cancer.

J Natl Cancer Inst 2002 May;94(9):662-9

Department of Medicine, Section of Medical Oncology, University of Wisconsin School of Medicine, Madison, 53705, USA.

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http://dx.doi.org/10.1093/jnci/94.9.662DOI Listing
May 2002

Statistics and ethics in medical research.

Authors:
David L DeMets

Sci Eng Ethics 1999 Jan;5(1):97-117

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http://dx.doi.org/10.1007/s11948-999-0059-9DOI Listing
January 1999