PubMed

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

Hennekens CH, DeMets DL, Bairey Merz CN, Borzak SL, Borer JS.

Am J Med. 2009 Apr;122(4):315-6. No abstract available. PMID: 19332222 [PubMed - indexed for MEDLINE]Related articles

Cardiovascular events associated with rofecoxib: final analysis of the APPROVe trial.

Baron JA, Sandler RS, Bresalier RS, Lanas A, Morton DG, Riddell R, Iverson ER, Demets DL.

Lancet. 2008 Nov 15;372(9651):1756-64. Epub 2008 Oct 14. Erratum in: Lancet. 2008 Nov 15;372(9651):1732. PMID: 18922570 [PubMed - indexed for MEDLINE]Related articles

Futility approaches to interim monitoring by data monitoring committees.

Demets DL.

Clin Trials. 2006;3(6):522-9. Review.PMID: 17170036 [PubMed - indexed for MEDLINE]Related articles

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

DeMets DL, Stormo G, Boehnke M, Louis TA, Taylor J, Dixon D.

Stat Med. 2006 Oct 30;25(20):3415-29.PMID: 16927449 [PubMed - indexed for MEDLINE]Related articles

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

DeMets DL, Fost N, Powers M.

Clin Trials. 2006;3(2):142-8.PMID: 16773956 [PubMed - indexed for MEDLINE]Related articles

Marketing drugs too early in testing.

Begg CB, Brawley O, Califf RM, Demets DL, Ellenberg SS, Kaplan RS.

Science. 2006 Apr 14;312(5771):195. No abstract available. PMID: 16614197 [PubMed - indexed for MEDLINE]Related articles

Conditional and unconditional confidence intervals following a group sequential test.

Fan X, DeMets DL.

J Biopharm Stat. 2006;16(1):107-22.PMID: 16440840 [PubMed - indexed for MEDLINE]Related articles

Rationale and design of the enoximone clinical trials program.

Lowes BD, Shakar SF, Metra M, Feldman AM, Eichhorn E, Freytag JW, Gerber MJ, Liard JF, Hartman C, Gorczynski R, Evans G, Linseman JV, Stewart J, Robertson AD, Roecker EB, Demets DL, Bristow MR.

J Card Fail. 2005 Dec;11(9):659-69.PMID: 16360960 [PubMed - indexed for MEDLINE]Related articles

Liability issues for data monitoring committee members.

DeMets DL, Fleming TR, Rockhold F, Massie B, Merchant T, Meisel A, Mishkin B, Wittes J, Stump D, Califf R.

Clin Trials. 2004;1(6):525-31.PMID: 16279293 [PubMed - indexed for MEDLINE]Related articles

Clinical effects of endothelin receptor antagonism with bosentan in patients with severe chronic heart failure: results of a pilot study.

Packer M, McMurray J, Massie BM, Caspi A, Charlon V, Cohen-Solal A, Kiowski W, Kostuk W, Krum H, Levine B, Rizzon P, Soler J, Swedberg K, Anderson S, Demets DL.

J Card Fail. 2005 Feb;11(1):12-20.PMID: 15704058 [PubMed - indexed for MEDLINE]Related articles

Conditional bias of point estimates following a group sequential test.

Fan XF, DeMets DL, Lan KK.

J Biopharm Stat. 2004 May;14(2):505-30.PMID: 15206542 [PubMed - indexed for MEDLINE]Related articles

The independent statistician for data monitoring committees.

DeMets DL, Fleming TR.

Stat Med. 2004 May 30;23(10):1513-7.PMID: 15122729 [PubMed - indexed for MEDLINE]Related articles

Statistical issues in interpreting clinical trials.

DeMets DL.

J Intern Med. 2004 May;255(5):529-37. Review.PMID: 15078496 [PubMed - indexed for MEDLINE]Related articles

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

Chen YH, DeMets DL, Lan KK.

Stat Med. 2004 Apr 15;23(7):1023-38.PMID: 15057876 [PubMed - indexed for MEDLINE]Related articles

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

Kosorok MR, Yuanjun S, DeMets DL.

Biometrics. 2004 Mar;60(1):134-45.PMID: 15032783 [PubMed - indexed for MEDLINE]Related articles

Toward protecting the safety of participants in clinical trials.

Califf RM, Morse MA, Wittes J, Goodman SN, Nelson DK, DeMets DL, Iafrate RP, Sugarman J.

Control Clin Trials. 2003 Jun;24(3):256-71.PMID: 12757992 [PubMed - indexed for MEDLINE]Related articles

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

Love RR, Duc NB, Havighurst TC, Mohsin SK, Zhang Q, DeMets DL, Allred DC.

J Clin Oncol. 2003 Feb 1;21(3):453-7.PMID: 12560434 [PubMed - indexed for MEDLINE]Related articles

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

Chen YH, DeMets DL, Lan KK.

Control Clin Trials. 2003 Feb;24(1):16-27.PMID: 12559639 [PubMed - indexed for MEDLINE]Related articles

Re: The influence of menstrual cycle phase on surgical treatment of primary breast cancer: have we made any progress over the past 13 years?

Love RR, Allred DC, DeMets DL.

J Natl Cancer Inst. 2002 Nov 20;94(22):1722-3; author reply 1723. No abstract available. PMID: 12441332 [PubMed - indexed for MEDLINE]Related articlesFree article

Effect of carvedilol on the morbidity of patients with severe chronic heart failure: results of the carvedilol prospective randomized cumulative survival (COPERNICUS) study.

Packer M, Fowler MB, Roecker EB, Coats AJ, Katus HA, Krum H, Mohacsi P, Rouleau JL, Tendera M, Staiger C, Holcslaw TL, Amann-Zalan I, DeMets DL; Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) Study Group.

Circulation. 2002 Oct 22;106(17):2194-9.PMID: 12390947 [PubMed - indexed for MEDLINE]Related articlesFree article

Monitoring clinical trials: issues and controversies regarding confidentiality.

Fleming TR, Ellenberg S, DeMets DL.

Stat Med. 2002 Oct 15;21(19):2843-51.PMID: 12325100 [PubMed - indexed for MEDLINE]Related articles

Clinical trials in the new millennium.

DeMets DL.

Stat Med. 2002 Oct 15;21(19):2779-87.PMID: 12325093 [PubMed - indexed for MEDLINE]Related articles

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

Califf RM, DeMets DL.

Circulation. 2002 Aug 27;106(9):1172-5. Review. No abstract available. PMID: 12196347 [PubMed - indexed for MEDLINE]Related articlesFree article

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

Califf RM, DeMets DL.

Circulation. 2002 Aug 20;106(8):1015-21. Review. No abstract available. PMID: 12186809 [PubMed - indexed for MEDLINE]Related articlesFree article

Lessons learned from recent cardiovascular clinical trials: Part II.

DeMets DL, Califf RM.

Circulation. 2002 Aug 13;106(7):880-6. Review. No abstract available. PMID: 12176964 [PubMed - indexed for MEDLINE]Related articlesFree article

Lessons learned from recent cardiovascular clinical trials: Part I.

DeMets DL, Califf RM.

Circulation. 2002 Aug 6;106(6):746-51. Review. No abstract available. PMID: 12163438 [PubMed - indexed for MEDLINE]Related articlesFree article

Oophorectomy and tamoxifen adjuvant therapy in premenopausal Vietnamese and Chinese women with operable breast cancer.

Love RR, Duc NB, Allred DC, Binh NC, Dinh NV, Kha NN, Thuan TV, Mohsin SK, Roanh le D, Khang HX, Tran TL, Quy TT, Thuy NV, Thé PN, Cau TT, Tung ND, Huong DT, Quang le M, Hien NN, Thuong L, Shen TZ, Xin Y, Zhang Q, Havighurst TC, Yang YF, Hillner BE, DeMets DL.

J Clin Oncol. 2002 May 15;20(10):2559-66.PMID: 12011136 [PubMed - indexed for MEDLINE]Related articles

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

Love RR, Duc NB, Dinh NV, Shen TZ, Havighurst TC, Allred DC, DeMets DL.

J Natl Cancer Inst. 2002 May 1;94(9):662-9.PMID: 11983754 [PubMed - indexed for MEDLINE]Related articlesFree article

Statistics and ethics in medical research.

DeMets DL.

Sci Eng Ethics. 1999 Jan;5(1):97-117. No abstract available. PMID: 11658016 [PubMed - indexed for MEDLINE]Related articles

Considerations in the evaluation of surrogate endpoints in clinical trials. summary of a National Institutes of Health workshop.

De Gruttola VG, Clax P, DeMets DL, Downing GJ, Ellenberg SS, Friedman L, Gail MH, Prentice R, Wittes J, Zeger SL.

Control Clin Trials. 2001 Oct;22(5):485-502.PMID: 11578783 [PubMed - indexed for MEDLINE]Related articles

Statistical issues relating to international differences in clinical trials.

O'Shea JC, DeMets DL.

Am Heart J. 2001 Jul;142(1):21-8. Review. No abstract available. PMID: 11431652 [PubMed - indexed for MEDLINE]Related articles

Effect of carvedilol on survival in severe chronic heart failure.

Packer M, Coats AJ, Fowler MB, Katus HA, Krum H, Mohacsi P, Rouleau JL, Tendera M, Castaigne A, Roecker EB, Schultz MK, DeMets DL; Carvedilol Prospective Randomized Cumulative Survival Study Group.

N Engl J Med. 2001 May 31;344(22):1651-8.PMID: 11386263 [PubMed - indexed for MEDLINE]Related articlesFree article

The Data and Safety Monitoring Committee: Some final thoughts.

DeMets DL, Yusuf S.

Am Heart J. 2001 Apr;141(4):548-9. No abstract available. PMID: 11275918 [PubMed - indexed for MEDLINE]Related articles

An overview of group sequential methods in longitudinal clinical trials.

Spiessens B, Lesaffre E, Verbeke G, Kim K, DeMets DL.

Stat Methods Med Res. 2000 Oct;9(5):497-515. Review.PMID: 11191262 [PubMed - indexed for MEDLINE]Related articles

The role of surrogate outcome measures in evaluating medical devices.

Demets DL.

Surgery. 2000 Sep;128(3):379-85. Review. No abstract available. PMID: 10965307 [PubMed - indexed for MEDLINE]Related articles

Estimating significance level and power comparisons for testing multiple endpoints in clinical trials.

Gong J, Pinheiro JC, DeMets DL.

Control Clin Trials. 2000 Aug;21(4):313-29.PMID: 10913807 [PubMed - indexed for MEDLINE]Related articles

Computations for group sequential boundaries using the Lan-DeMets spending function method.

Reboussin DM, DeMets DL, Kim KM, Lan KK.

Control Clin Trials. 2000 Jun;21(3):190-207.PMID: 10822118 [PubMed - indexed for MEDLINE]Related articles

Design of phase II trials in congestive heart failure.

DeMets DL.

Am Heart J. 2000 Apr;139(4):S207-10. No abstract available. PMID: 10740134 [PubMed - indexed for MEDLINE]Related articles

The agonising negative trend in monitoring of clinical trials.

DeMets DL, Pocock SJ, Julian DG.

Lancet. 1999 Dec 4;354(9194):1983-8. Review.PMID: 10622312 [PubMed - indexed for MEDLINE]Related articles

A dose-dependent increase in mortality with vesnarinone among patients with severe heart failure. Vesnarinone Trial Investigators.

Cohn JN, Goldstein SO, Greenberg BH, Lorell BH, Bourge RC, Jaski BE, Gottlieb SO, McGrew F 3rd, DeMets DL, White BG.

N Engl J Med. 1998 Dec 17;339(25):1810-6.PMID: 9854116 [PubMed - indexed for MEDLINE]Related articlesFree article

Effect of amlodipine on mode of death among patients with advanced heart failure in the PRAISE trial. Prospective Randomized Amlodipine Survival Evaluation.

O'Connor CM, Carson PE, Miller AB, Pressler ML, Belkin RN, Neuberg GW, Frid DJ, Cropp AB, Anderson S, Wertheimer JH, DeMets DL.

Am J Cardiol. 1998 Oct 1;82(7):881-7.PMID: 9781971 [PubMed - indexed for MEDLINE]Related articles

Distinctions between fraud, bias, errors, misunderstanding, and incompetence.

DeMets DL.

Control Clin Trials. 1997 Dec;18(6):637-50; discussion 661-6. Review.PMID: 9408726 [PubMed - indexed for MEDLINE]Related articles

Surrogate endpoints.

Fleming TR, DeGruttola V, DeMets DL.

AIDS Clin Rev. 1997-1998:129-43. Review. No abstract available. PMID: 9305447 [PubMed - indexed for MEDLINE]Related articles

Effect of amlodipine on morbidity and mortality in severe chronic heart failure. Prospective Randomized Amlodipine Survival Evaluation Study Group.

Packer M, O'Connor CM, Ghali JK, Pressler ML, Carson PE, Belkin RN, Miller AB, Neuberg GW, Frid D, Wertheimer JH, Cropp AB, DeMets DL.

N Engl J Med. 1996 Oct 10;335(15):1107-14.PMID: 8813041 [PubMed - indexed for MEDLINE]Related articlesFree article

Surrogate end points in clinical trials: are we being misled?

Fleming TR, DeMets DL.

Ann Intern Med. 1996 Oct 1;125(7):605-13. Review. No abstract available. PMID: 8815760 [PubMed - indexed for MEDLINE]Related articlesFree article

The data and safety monitoring board and acquired immune deficiency syndrome (AIDS) clinical trials.

DeMets DL, Fleming TR, Whitley RJ, Childress JF, Ellenberg SS, Foulkes M, Mayer KH, O'Fallon J, Pollard RB, Rahal JJ, et al.

Control Clin Trials. 1995 Dec;16(6):408-21.PMID: 8720018 [PubMed - indexed for MEDLINE]Related articles

A comparison of methods for correlated ordinal measures with ophthalmic applications.

Gange SJ, Linton KL, Scott AJ, DeMets DL, Klein R.

Stat Med. 1995 Sep 30;14(18):1961-74.PMID: 8677397 [PubMed - indexed for MEDLINE]Related articles

Group sequential comparison of changes: ad-hoc versus more exact method.

Lee JW, DeMets DL.

Biometrics. 1995 Mar;51(1):21-30.PMID: 7766776 [PubMed - indexed for MEDLINE]Related articles

The alpha spending function approach to interim data analyses.

DeMets DL, Lan G.

Cancer Treat Res. 1995;75:1-27. Review. No abstract available. PMID: 7640159 [PubMed - indexed for MEDLINE]Related articles

Insights from monitoring the CPCRA didanosine/zalcitabine trial. Terry Beirn Community Programs for Clinical Research on AIDS.

Fleming TR, Neaton JD, Goldman A, DeMets DL, Launer C, Korvick J, Abrams D.

J Acquir Immune Defic Syndr Hum Retrovirol. 1995;10 Suppl 2:S9-18.PMID: 7552519 [PubMed - indexed for MEDLINE]Related articles