Thomas R Fleming

Summary

Affiliation: University of Washington
Country: USA

Publications

  1. ncbi request reprint Current issues in non-inferiority trials
    Thomas R Fleming
    Department of Biostatistics, University of Washington, Seattle, WA 98195, USA
    Stat Med 27:317-32. 2008
  2. pmc Biomarkers and surrogate endpoints in clinical trials
    Thomas R Fleming
    Department of Biostatistics, University of Washington, Seattle, WA, USA
    Stat Med 31:2973-84. 2012
  3. pmc Maintaining confidentiality of interim data to enhance trial integrity and credibility
    Thomas R Fleming
    Department of Biostatistics, University of Washington, Seattle, WA 98195, USA
    Clin Trials 5:157-67. 2008
  4. ncbi request reprint Standard versus adaptive monitoring procedures: A commentary
    Thomas R Fleming
    Department of Biostatistics, University of Washington, Seattle, Washington, USA
    Stat Med 25:3305-12; discussion 3313-4, 3326-47. 2006
  5. pmc Issues in noninferiority trials: the evidence in community-acquired pneumonia
    Thomas R Fleming
    Department of Biostatistics, University of Washington, Seattle, WA 98195, USA
    Clin Infect Dis 47:S108-20. 2008
  6. pmc Issues in using progression-free survival when evaluating oncology products
    Thomas R Fleming
    Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195 7232, USA
    J Clin Oncol 27:2874-80. 2009
  7. pmc Clinical trials: discerning hype from substance
    Thomas R Fleming
    University of Washington, Seattle, WA, USA
    Ann Intern Med 153:400-6. 2010
  8. ncbi request reprint Surrogate endpoints and FDA's accelerated approval process
    Thomas R Fleming
    Department of Biostatistics, University of Washington, Seattle, USA
    Health Aff (Millwood) 24:67-78. 2005
  9. ncbi request reprint Some design issues in trials of microbicides for the prevention of HIV infection
    Thomas R Fleming
    Department of Biostatistics, University of Washington, Seattle, Washington 98195, USA
    J Infect Dis 190:666-74. 2004
  10. pmc Addressing missing data in clinical trials
    Thomas R Fleming
    University of Washington, Seattle, 98195 7232, USA
    Ann Intern Med 154:113-7. 2011

Research Grants

Collaborators

Detail Information

Publications29

  1. ncbi request reprint Current issues in non-inferiority trials
    Thomas R Fleming
    Department of Biostatistics, University of Washington, Seattle, WA 98195, USA
    Stat Med 27:317-32. 2008
    ....
  2. pmc Biomarkers and surrogate endpoints in clinical trials
    Thomas R Fleming
    Department of Biostatistics, University of Washington, Seattle, WA, USA
    Stat Med 31:2973-84. 2012
    ....
  3. pmc Maintaining confidentiality of interim data to enhance trial integrity and credibility
    Thomas R Fleming
    Department of Biostatistics, University of Washington, Seattle, WA 98195, USA
    Clin Trials 5:157-67. 2008
    ..However, we have found that the principle of confidentiality is not always followed in practice, particularly where the interim data include complete results on a short-term outcome measure...
  4. ncbi request reprint Standard versus adaptive monitoring procedures: A commentary
    Thomas R Fleming
    Department of Biostatistics, University of Washington, Seattle, Washington, USA
    Stat Med 25:3305-12; discussion 3313-4, 3326-47. 2006
    ....
  5. pmc Issues in noninferiority trials: the evidence in community-acquired pneumonia
    Thomas R Fleming
    Department of Biostatistics, University of Washington, Seattle, WA 98195, USA
    Clin Infect Dis 47:S108-20. 2008
    ..This review allows formulation of NI margins that are specific to age and bacteremia status of patients...
  6. pmc Issues in using progression-free survival when evaluating oncology products
    Thomas R Fleming
    Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195 7232, USA
    J Clin Oncol 27:2874-80. 2009
    ....
  7. pmc Clinical trials: discerning hype from substance
    Thomas R Fleming
    University of Washington, Seattle, WA, USA
    Ann Intern Med 153:400-6. 2010
    ..Awareness of these issues will meaningfully improve our ability to be guided by substance, not hype, in making evidence-based decisions about medical care...
  8. ncbi request reprint Surrogate endpoints and FDA's accelerated approval process
    Thomas R Fleming
    Department of Biostatistics, University of Washington, Seattle, USA
    Health Aff (Millwood) 24:67-78. 2005
    ....
  9. ncbi request reprint Some design issues in trials of microbicides for the prevention of HIV infection
    Thomas R Fleming
    Department of Biostatistics, University of Washington, Seattle, Washington 98195, USA
    J Infect Dis 190:666-74. 2004
    ..The issues considered in microbicide trials for the prevention of HIV infection are also of importance in many other clinical scenarios...
  10. pmc Addressing missing data in clinical trials
    Thomas R Fleming
    University of Washington, Seattle, 98195 7232, USA
    Ann Intern Med 154:113-7. 2011
    ..To meaningfully reduce missing data, it is important to recognize and address many factors that commonly lead to higher levels of missingness...
  11. pmc Some essential considerations in the design and conduct of non-inferiority trials
    Thomas R Fleming
    Department of Biostatistics, University of Washington, Seattle, WA 98195 7232, USA
    Clin Trials 8:432-9. 2011
    ..Formally, the non-inferiority trial usually is designed to rule out a non-inferiority margin, defined as the minimum threshold for what would constitute an unacceptable loss of efficacy...
  12. pmc Study design considerations for evaluating efficacy of systemic preexposure prophylaxis interventions
    Deborah Donnell
    Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA
    J Acquir Immune Defic Syndr 63:S130-4. 2013
    ..This development is particularly complex because of inconsistency of efficacy results of FTC/TDF PrEP trials for HIV prevention...
  13. doi request reprint Adaptive methods: telling "the rest of the story"
    Scott S Emerson
    Department of Biostatistics, University of Washington, Seattle, Washington, USA
    J Biopharm Stat 20:1150-65. 2010
    ....
  14. ncbi request reprint Monitoring clinical trials: issues and controversies regarding confidentiality
    Thomas R Fleming
    Department of Biostatistics, University of Washington, Seattle, Washington 98195 7232, USA
    Stat Med 21:2843-51. 2002
    ..However, to address the ethical imperative to protect the interests of study participants, the DMC itself should have access to unblinded efficacy and safety results...
  15. doi request reprint Idiopathic pulmonary fibrosis: clinically meaningful primary endpoints in phase 3 clinical trials
    Ganesh Raghu
    Division of Pulmonary and Critical Care Medicine, Campus Box 356175, University of Washington, Seattle, WA 98195, USA
    Am J Respir Crit Care Med 185:1044-8. 2012
    ..For patients with IPF, there are currently no validated surrogate endpoints...
  16. pmc Challenges in the design of HIV prevention trials in the United States
    Deborah Donnell
    Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA
    J Acquir Immune Defic Syndr 55:S136-40. 2010
    ..However, for interventions where efficacy is already established, conducting trials that test different implementation strategies in these populations could provide definitive evidence about how to achieve high levels of coverage...
  17. pmc Statistical considerations for the HPTN 052 Study to evaluate the effectiveness of early versus delayed antiretroviral strategies to prevent the sexual transmission of HIV-1 in serodiscordant couples
    Ying Qing Chen
    Statistical Center for HIV Aids Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA
    Contemp Clin Trials 33:1280-6. 2012
    ..Nevertheless, the durability of its long-term effectiveness is yet to be assessed. The HPTN 052 Study is still ongoing and will not complete till 2015...
  18. ncbi request reprint Evaluating rivaroxaban for nonvalvular atrial fibrillation - regulatory considerations
    Thomas R Fleming
    From the Department of Biostatistics, University of Washington, Seattle
    N Engl J Med 365:1557-9. 2011
    ....
  19. ncbi request reprint Adaptive test for testing the difference in survival distributions
    Monika Pecková
    Department of Biostatistics, University of Washington, Seattle 98185 7232, USA
    Lifetime Data Anal 9:223-38. 2003
    ..Simulations demonstrate that the adaptive test enjoys good small sample properties and in most situations is more powerful than the test using the maximum of the tests in T...
  20. ncbi request reprint The independent statistician for data monitoring committees
    David L Demets
    Department of Biostatistics and Medical Informatics, University of Wisconsin Madison, 600 Highland Avenue, Box 4675, Madison, WI 53792 4675, USA
    Stat Med 23:1513-7. 2004
    ..These views are based on having served as members of many DMCs as well as having been the independent statistician for several trials...
  21. ncbi request reprint Simultaneous use of weighted logrank and standardized Kaplan-Meier statistics
    Peiling Yang
    Food and Drug Administration, Silver Spring, Maryland, USA
    J Biopharm Stat 16:241-52. 2006
    ..Simulations are used to assess small sample properties of this approach and its usefulness is illustrated in important recent oncology clinical trials...
  22. ncbi request reprint 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)
    Francis J Giles
    Department of Leukemia, The University of Texas, M D Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 428, Houston, TX 77030, USA
    Leuk Lymphoma 44:1165-72. 2003
    ..6 and 2.0 (P = 0.0131). Iseganan was well tolerated; no systemic absorption was detected. Iseganan is safe and may be effective in reducing UOM and its clinical sequelae...
  23. ncbi request reprint A phase III, randomized, double-blind, placebo-controlled, study of iseganan for the reduction of stomatitis in patients receiving stomatotoxic chemotherapy
    Francis J Giles
    M D Anderson Cancer Center, Department of Leukemia, The University of Texas, 1515 Holcombe Boulevard, Box 428, Houston, TX 77030, USA
    Leuk Res 28:559-65. 2004
    ..A major impact of Iseganan on reducing stomatitis, UOM, or its clinical sequelae in patients receiving stomatotoxic therapy was not detected on this study...
  24. ncbi request reprint Objective response rate as a surrogate end point: a commentary
    Thomas R Fleming
    J Clin Oncol 23:4845-6. 2005
  25. ncbi request reprint A randomized double-blind trial of iseganan in prevention of ventilator-associated pneumonia
    Marin Kollef
    Washington University School of Medicine, 660 South Euclid Avenue, Campus Box 8052, St Louis, MO 63110, USA
    Am J Respir Crit Care Med 173:91-7. 2006
    ..The drug has shown little resistance in vitro and to be safe and well tolerated in 800 patients with cancer treated for up to 6 wk...
  26. ncbi request reprint Liability issues for data monitoring committee members
    David L Demets
    University of Wisconsin, Madison, WI, USA
    Clin Trials 1:525-31. 2004
    ..This paper discusses these issues and suggests sample language for indemnification agreements to protect DMC members. This type of language should be included in DMC charters and in all consulting agreements signed by DMC members...
  27. pmc Identifying and addressing safety signals in clinical trials
    Thomas R Fleming
    N Engl J Med 359:1400-2. 2008
  28. pmc Morbidity and mortality among a cohort of human immunodeficiency virus type 1-infected and uninfected pregnant women and their infants from Malawi, Zambia, and Tanzania
    David Chilongozi
    University of North Carolina Project, Lilongwe, Malawi
    Pediatr Infect Dis J 27:808-14. 2008
    ..Morbidity and mortality patterns among pregnant women and their infants (before antiretroviral therapy was widely available) determines HIV-1 diagnostic, monitoring, and care interventions...
  29. doi request reprint Antithrombotic drug development for atrial fibrillation: proceedings, Washington, DC, July 25-27, 2005
    Kevin Jackson
    Duke Clinical Research Institute, Durham, NC 27705, USA
    Am Heart J 155:829-40. 2008
    ..With this summary document, we hope to provide a helpful resource for future drug development for AF...

Research Grants6

  1. HIV PREVENTION TRIALS NETWORK LEADERSHIP GROUP
    Thomas Fleming; Fiscal Year: 2005
    ..abstract_text> ..
  2. STATISTICAL ISSUES IN AIDS RESEARCH
    Thomas Fleming; Fiscal Year: 2007
    ..Research into optimal designs of Phase HE "Intermediate Trials" of candidate HIV vaccines will also be continued. ..
  3. Leadership for HIV/AIDS Clinical Trials Networks; HIV Prevention Trials Network
    Thomas Fleming; Fiscal Year: 2007
    ..Therefore, the need for finding other types of effective prevention measures is critical. Only through clinical trials held to the highest scientific and regulatory standards will this goal be achieved. ..
  4. CLINICAL RESEARCH ON AIDS TRAINING GRANT
    Thomas Fleming; Fiscal Year: 2007
    ..Program prerequisites include linear algebra, probability, and two years of calculus; promising students with biology majors may be admitted provisionally if they have not satisfied all the mathematical prerequisites. ..