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Thomas Fleming, PhD

  • Professor and Former Chair, Biostatistics
  • University of Washington

.Dr. Fleming is Professor of the Department of Biostatistics, Member of the Fred Hutchinson Cancer Research Center, and the former Director of the Statistical Center for HIV/AIDS Prevention Trial Network, NIAID. He has authored or coauthored several books and more than 250 research articles in peer-reviewed journals, many regarding the development of state of the art methods for the design, conduct and analysis of clinical trials, and many others reporting the results of landmark trials, including the 2011 publication in NEJM on prevention of transmission of HIV. This research, on which he was senior author, was recognized by Science Magazine to be the scientific "Breakthrough of the Year". He has chaired or served on Data Monitoring Committees for more than 100 clinical trials. He is a Special Government Employee for the FDA, and for more than 25 years he has served as a regular member of several FDA Advisory Committees and as an invited voting member on more than 100 occasions. Dr Fleming h as received numerous awards. He is recipient of the Outstanding Teaching Award, School of Public Health from the University of Washington, and the FDA Commissioner's Special Citation Award for Extraordinary Contribution to the Agency. He is the 2007 Greenberg Lecturer at University of North Carolina, the 2009 Distinguished Lecturer at the School of Public Health at the University of Washington and, in 2011, the Ross Prentice Endowed Professor of Biostatistical Collaboration. In 2012, he was elected to membership in the Institute of Medicine of the National Academies.

Selected Publications

Fleming TR. Clinical Trials: Discerning Hype from Substance. Annals of Internal Medicine 153: 400-406, 2010.
PubMed Abstract

Fleming TR. Addressing Missing Data in Clinical Trials. Annals of Internal Medicine 154: 113-117, 2011.
PubMed Abstract

Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JHS, Godbole SV, Mehendale S, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Wang L, Makhema J, Mills LA, de Bruyn G, Sanne I, Eron J, Gallant J,Havlir D, Swindells S, Ribaudo H, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano D, Essex M, Fleming TR, for the HPTN 052 Study Team. Prevention of HIV-1 Infection with Early Antiretroviral Therapy. N Engl J Med 365: 493-505, 2011.
PubMed Abstract

Fleming TR, Odem-Davis K, Rothmann MD, Shen YL. Some Essential Considerations in the Design and Conduct of Non-Inferiority Trials. Clinical Trials 8:432-439, 2011.
PubMed Abstract

Fleming TR, Powers JH. Biomarkers and Surrogate Endpoints in Clinical Trials.  Statistics in Medicine. 31: 2973-2984, 2012.
PubMed Abstract

Fleming TR, DeMets DL, Hennekens CH, Pfeffer MA. Enhancing Trial Integrity by Protecting the Independence of Data Monitoring Committees in Clinical Trials.  J Biopharmaceutical Statistics 24 (5): 968-975, 2014
PubMed Abstract

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