PubMed

Design, conduct, and analysis of clinical trials in disease due to methicillin-resistant Staphylococcus aureus.

Powers JH, Fleming TR.

Clin Pharmacol Ther. 2009 Sep;86(3):244-7.PMID: 19707216 [PubMed - indexed for MEDLINE]Related articles

End points and clinical trial design in pulmonary arterial hypertension.

McLaughlin VV, Badesch DB, Delcroix M, Fleming TR, Gaine SP, Galiè N, Gibbs JS, Kim NH, Oudiz RJ, Peacock A, Provencher S, Sitbon O, Tapson VF, Seeger W.

J Am Coll Cardiol. 2009 Jun 30;54(1 Suppl):S97-107. Review.PMID: 19555863 [PubMed - indexed for MEDLINE]Related articles

Issues in using progression-free survival when evaluating oncology products.

Fleming TR, Rothmann MD, Lu HL.

J Clin Oncol. 2009 Jun 10;27(17):2874-80. Epub 2009 May 4.PMID: 19414672 [PubMed - indexed for MEDLINE]Related articles

Issues in noninferiority trials: the evidence in community-acquired pneumonia.

Fleming TR, Powers JH.

Clin Infect Dis. 2008 Dec 1;47 Suppl 3:S108-20. Review.PMID: 18986275 [PubMed - indexed for MEDLINE]Related articlesFree article

Executive summary: workshop on issues in the design and conduct of clinical trials of antibacterial drugs in the treatment of community-acquired pneumonia.

Spellberg B, Fleming TR, Gilbert DN.

Clin Infect Dis. 2008 Dec 1;47 Suppl 3:S105-7. No abstract available. PMID: 18986274 [PubMed - indexed for MEDLINE]Related articlesFree article

Addition of sildenafil to long-term intravenous epoprostenol therapy in patients with pulmonary arterial hypertension: a randomized trial.

Simonneau G, Rubin LJ, Galiè N, Barst RJ, Fleming TR, Frost AE, Engel PJ, Kramer MR, Burgess G, Collings L, Cossons N, Sitbon O, Badesch DB; PACES Study Group.

Ann Intern Med. 2008 Oct 21;149(8):521-30. Erratum in: Ann Intern Med. 2009 Jan 6;150(1):63. Ann Intern Med. 2009 Sep 15;151(6):435. PMID: 18936500 [PubMed - indexed for MEDLINE]Related articlesFree article

Identifying and addressing safety signals in clinical trials.

Fleming TR.

N Engl J Med. 2008 Sep 25;359(13):1400-2. Epub 2008 Sep 3. No abstract available. PMID: 18768938 [PubMed - indexed for MEDLINE]Related articlesFree article

Sitaxsentan for the treatment of pulmonary arterial hypertension: a 1-year, prospective, open-label observation of outcome and survival.

Benza RL, Barst RJ, Galie N, Frost A, Girgis RE, Highland KB, Strange C, Black CM, Badesch DB, Rubin L, Fleming TR, Naeije R.

Chest. 2008 Oct;134(4):775-82. Epub 2008 Jul 14. Erratum in: Chest. 2009 Apr;135(4):1114. PMID: 18625676 [PubMed - indexed for MEDLINE]Related articlesFree article

Magnetic resonance imaging as a surrogate outcome for multiple sclerosis relapses.

Petkau J, Reingold SC, Held U, Cutter GR, Fleming TR, Hughes MD, Miller DH, McFarland HF, Wolinsky JS.

Mult Scler. 2008 Jul;14(6):770-8. Epub 2008 Jun 5.PMID: 18535021 [PubMed - indexed for MEDLINE]Related articlesFree article

Antithrombotic drug development for atrial fibrillation: proceedings, Washington, DC, July 25-27, 2005.

Jackson K, Gersh BJ, Stockbridge N, Fleming TR, Temple R, Califf RM, Connolly SJ, Wallentin L, Granger CB; Duke Clinical Research Institute/American Heart Journal Expert Meeting on Antithrombotic Drug Development for Atrial Fibrillation.

Am Heart J. 2008 May;155(5):829-40. Review.PMID: 18440329 [PubMed - indexed for MEDLINE]Related articles

Maintaining confidentiality of interim data to enhance trial integrity and credibility.

Fleming TR, Sharples K, McCall J, Moore A, Rodgers A, Stewart R.

Clin Trials. 2008;5(2):157-67.PMID: 18375654 [PubMed - indexed for MEDLINE]Related articlesFree article

Recommended changes to oncology clinical trial design: revolution or evolution?

Ratain MJ, Humphrey RW, Gordon GB, Fyfe G, Adamson PC, Fleming TR, Stadler WM, Berry DA, Peck CC.

Eur J Cancer. 2008 Jan;44(1):8-11. Epub 2007 Nov 5. No abstract available. PMID: 17981025 [PubMed - indexed for MEDLINE]Related articlesFree article

Current issues in non-inferiority trials.

Fleming TR.

Stat Med. 2008 Feb 10;27(3):317-32.PMID: 17340597 [PubMed - indexed for MEDLINE]Related articles

A phase 2/3 multicenter randomized clinical trial of ABX-CBL versus ATG as secondary therapy for steroid-resistant acute graft-versus-host disease.

Macmillan ML, Couriel D, Weisdorf DJ, Schwab G, Havrilla N, Fleming TR, Huang S, Roskos L, Slavin S, Shadduck RK, Dipersio J, Territo M, Pavletic S, Linker C, Heslop HE, Joachim Deeg H, Blazar BR.

Blood. 2007 Mar 15;109(6):2657-62. Epub 2006 Nov 16.PMID: 17110457 [PubMed - indexed for MEDLINE]Related articlesFree article

Standard versus adaptive monitoring procedures: A commentary.

Fleming TR.

Stat Med. 2006 Oct 15;25(19):3305-12; discussion 3313-4, 3326-47.PMID: 16850447 [PubMed - indexed for MEDLINE]Related articles

Simultaneous use of weighted logrank and standardized Kaplan-Meier statistics.

Yang P, Fleming TR.

J Biopharm Stat. 2006;16(2):241-52.PMID: 16584070 [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

A randomized double-blind trial of iseganan in prevention of ventilator-associated pneumonia.

Kollef M, Pittet D, Sánchez García M, Chastre J, Fagon JY, Bonten M, Hyzy R, Fleming TR, Fuchs H, Bellm L, Mercat A, Mañez R, Martínez A, Eggimann P, Daguerre M, Luyt CE; Prevention of Pneumonia Study (POPS-1) Trial Group.

Am J Respir Crit Care Med. 2006 Jan 1;173(1):91-7. Epub 2005 Sep 28.PMID: 16192451 [PubMed - indexed for MEDLINE]Related articlesFree article

Objective response rate as a surrogate end point: a commentary.

Fleming TR.

J Clin Oncol. 2005 Aug 1;23(22):4845-6. Epub 2005 Jun 13. No abstract available. PMID: 15955898 [PubMed - indexed for MEDLINE]Related articles

Surrogate endpoints and FDA's accelerated approval process.

Fleming TR.

Health Aff (Millwood). 2005 Jan-Feb;24(1):67-78.PMID: 15647217 [PubMed - indexed for MEDLINE]Related articles

Some design issues in trials of microbicides for the prevention of HIV infection.

Fleming TR, Richardson BA.

J Infect Dis. 2004 Aug 15;190(4):666-74. Epub 2004 Jul 20.PMID: 15272392 [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

A phase III, randomized, double-blind, placebo-controlled, study of iseganan for the reduction of stomatitis in patients receiving stomatotoxic chemotherapy.

Giles FJ, Rodriguez R, Weisdorf D, Wingard JR, Martin PJ, Fleming TR, Goldberg SL, Anaissie EJ, Bolwell BJ, Chao NJ, Shea TC, Brunvand MM, Vaughan W, Petersen F, Schubert M, Lazarus HM, Maziarz RT, Silverman M, Beveridge RA, Redman R, Pulliam JG, Devitt-Risse P, Fuchs HJ, Hurd DD.

Leuk Res. 2004 Jun;28(6):559-65.PMID: 15120931 [PubMed - indexed for MEDLINE]Related articles

A multinational, randomized phase III trial of iseganan HCl oral solution for reducing the severity of oral mucositis in patients receiving radiotherapy for head-and-neck malignancy.

Trotti A, Garden A, Warde P, Symonds P, Langer C, Redman R, Pajak TF, Fleming TR, Henke M, Bourhis J, Rosenthal DI, Junor E, Cmelak A, Sheehan F, Pulliam J, Devitt-Risse P, Fuchs H, Chambers M, O'Sullivan B, Ang KK.

Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):674-81.PMID: 14967419 [PubMed - indexed for MEDLINE]Related articles

Tolerance and safety of different concentrations of chlorhexidine for peripartum vaginal and infant washes: HIVNET 025.

Wilson CM, Gray G, Read JS, Mwatha A, Lala S, Johnson S, Violari A, Sibiya PM, Fleming TR, Koonce A, Vermund SH, McIntyre J.

J Acquir Immune Defic Syndr. 2004 Feb 1;35(2):138-43.PMID: 14722445 [PubMed - indexed for MEDLINE]Related articlesFree article

Adaptive test for testing the difference in survival distributions.

Pecková M, Fleming TR.

Lifetime Data Anal. 2003 Sep;9(3):223-38.PMID: 14649843 [PubMed - indexed for MEDLINE]Related articles

A phase III, randomized, double-blind, placebo-controlled, multinational trial of iseganan for the prevention of oral mucositis in patients receiving stomatotoxic chemotherapy (PROMPT-CT trial).

Giles FJ, Miller CB, Hurd DD, Wingard JR, Fleming TR, Sonis ST, Bradford WZ, Pulliam JG, Anaissie EJ, Beveridge RA, Brunvand MM, Martin PJ; PROMPT-CT Trial Investigators.

Leuk Lymphoma. 2003 Jul;44(7):1165-72.PMID: 12916869 [PubMed - indexed for MEDLINE]Related articles

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

Evaluating the safety of interventions for prevention of perinatal transmission of HIV.

Fleming TR.

Ann N Y Acad Sci. 2000 Nov;918:201-11.PMID: 11131706 [PubMed - indexed for MEDLINE]Related articles

Survival analysis in clinical trials: past developments and future directions.

Fleming TR, Lin DY.

Biometrics. 2000 Dec;56(4):971-83. Review.PMID: 11129494 [PubMed - indexed for MEDLINE]Related articles

Surrogate end points in cardiovascular disease trials.

Fleming TR.

Am Heart J. 2000 Apr;139(4):S193-6. No abstract available. PMID: 10740130 [PubMed - indexed for MEDLINE]Related articles

Design and interpretation of equivalence trials.

Fleming TR.

Am Heart J. 2000 Apr;139(4):S171-6. No abstract available. PMID: 10740126 [PubMed - indexed for MEDLINE]Related articles

Safety and toxicity of nonoxynol-9 gel as a rectal microbicide.

Tabet SR, Surawicz C, Horton S, Paradise M, Coletti AS, Gross M, Fleming TR, Buchbinder S, Haggitt RC, Levine H, Kelly CW, Celum CL.

Sex Transm Dis. 1999 Nov;26(10):564-71.PMID: 10560720 [PubMed - indexed for MEDLINE]Related articles

Issues in the design of clinical trials: insights from the trastuzumab (Herceptin) experience.

Fleming TR.

Semin Oncol. 1999 Aug;26(4 Suppl 12):102-7.PMID: 10482201 [PubMed - indexed for MEDLINE]Related articles

Surrogate end points, health outcomes, and the drug-approval process for the treatment of risk factors for cardiovascular disease.

Psaty BM, Weiss NS, Furberg CD, Koepsell TD, Siscovick DS, Rosendaal FR, Smith NL, Heckbert SR, Kaplan RC, Lin D, Fleming TR, Wagner EH.

JAMA. 1999 Aug 25;282(8):786-90. No abstract available. PMID: 10463718 [PubMed - indexed for MEDLINE]Related articles

Assessing effects on long-term survival after early termination of randomized trials.

Shen Y, Fleming TR.

Lifetime Data Anal. 1999;5(1):55-66.PMID: 10214002 [PubMed - indexed for MEDLINE]Related articles

Monitoring clinical trials.

Sharples K, Fleming TR, MacMahon S, Moore A, Reid I, Scoggins B.

N Z Med J. 1998 Aug 28;111(1072):322-5. Review. No abstract available. PMID: 9765633 [PubMed - indexed for MEDLINE]Related articles

Surgery for recurrent colon cancer: strategies for identifying resectable recurrence and success rates after resection. Eastern Cooperative Oncology Group, the North Central Cancer Treatment Group, and the Southwest Oncology Group.

Goldberg RM, Fleming TR, Tangen CM, Moertel CG, Macdonald JS, Haller DG, Laurie JA.

Ann Intern Med. 1998 Jul 1;129(1):27-35.PMID: 9652996 [PubMed - indexed for MEDLINE]Related articlesFree article

Estimating the proportion of treatment effect explained by a surrogate marker.

Lin DY, Fleming TR, De Gruttola V.

Stat Med. 1997 Jul 15;16(13):1515-27.PMID: 9249922 [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

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

Phase II trial of low-dose N-(phosphonacetyl)-disodium L-aspartic acid and high-dose 24-hour infusional 5-fluorouracil in advanced gastric adenocarcinoma. A Southwest Oncology Group study.

Martino RL, Fleming TR, Morrell LM, Ardalan B, Richman SP, Macdonald JS.

Invest New Drugs. 1996;14(4):419-21.PMID: 9157080 [PubMed - indexed for MEDLINE]Related articles

Phase II trial of trimetrexate in advanced esophageal cancer: a southwest oncology group study.

Fleming TR, Brown TD, Ross SW, Macdonald JS.

Invest New Drugs. 1996;13(4):363-5.PMID: 8824358 [PubMed - indexed for MEDLINE]Related articles

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

Diagnostic plots to reveal functional form for covariates in multiplicative intensity models.

Grambsch PM, Therneau TM, Fleming TR.

Biometrics. 1995 Dec;51(4):1469-82.PMID: 8589234 [PubMed - indexed for MEDLINE]Related articles

Intergroup study of fluorouracil plus levamisole as adjuvant therapy for stage II/Dukes' B2 colon cancer.

Moertel CG, Fleming TR, Macdonald JS, Haller DG, Laurie JA, Tangen CM, Ungerleider JS, Emerson WA, Tormey DC, Glick JH, et al.

J Clin Oncol. 1995 Dec;13(12):2936-43.PMID: 8523058 [PubMed - indexed for MEDLINE]Related articles

Adjuvant chemotherapy with 5-FU, adriamycin, and mitomycin-C (FAM) versus surgery alone for patients with locally advanced gastric adenocarcinoma: A Southwest Oncology Group study.

Macdonald JS, Fleming TR, Peterson RF, Berenberg JL, McClure S, Chapman RA, Eyre HJ, Solanki D, Cruz AB Jr, Gagliano R, et al.

Ann Surg Oncol. 1995 Nov;2(6):488-94.PMID: 8591078 [PubMed - indexed for MEDLINE]Related articles

Phase II study of 5-fluorouracil and folinic acid in the treatment of patients with advanced gastric cancer. A Southwest Oncology Group study.

Berenberg JL, Tangen C, Macdonald JS, Hutchins LF, Natale RB, Oishi N, Guy JT, Fleming TR.

Cancer. 1995 Sep 1;76(5):715-9.PMID: 8625171 [PubMed - indexed for MEDLINE]Related articles

Phase II study of fluorouracil and its modulation in advanced colorectal cancer: a Southwest Oncology Group study.

Leichman CG, Fleming TR, Muggia FM, Tangen CM, Ardalan B, Doroshow JH, Meyers FJ, Holcombe RF, Weiss GR, Mangalik A, et al.

J Clin Oncol. 1995 Jun;13(6):1303-11.PMID: 7751875 [PubMed - indexed for MEDLINE]Related articles

Adjuvant continuous infusion 5-FU, whole-abdominal radiation, and tumor bed boost in high-risk stage III colon carcinoma: a Southwest Oncology Group Pilot study.

Fabian C, Giri S, Estes N, Tangen CM, Poplin E, Vogel S, Goodwin W, Rivkin S, Fleming TR, Macdonald JS.

Int J Radiat Oncol Biol Phys. 1995 May 15;32(2):457-64.PMID: 7751186 [PubMed - indexed for MEDLINE]Related articles