James D. Neaton PhD » Faculty

Research Interests:Design, conduct, and analysis of clinical trials; application of statistical models to the analysis of data arising from intervention studies; and collaborative work in cardiovascular disease prevention and AIDS research

Professor, Biostatistics

Address 2221 University Avenue SE Room 200 Minneapolis MN 55414 Work Phone: 612-626-9040 Website: http://www.biostat.umn.edu/~jim
Photo of James D. Neaton PhD

Biography:

James Neaton has research interests in the design, conduct and analysis of clinical trials. He leads an international HIV clinical trials group (INSIGHT) and remains in involved in clinical trials aimed at the prevention of cardiovascular disease.  He teaches a course on clinical trials.   Dr. Neaton served as Editor of Controlled Clinical Trials from 1999-2003.  He has served on several national committees and advisory panels including theU.S. Public Health Service Panel on Clinical Practices for the Treatment of HIV Infection, the Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee, and the National Academy of Sciences, Committee on National Statistics Oversight Committee for Workshop on Handling Missing Data in Clinical Trials.

  • Ph.D., Biometry, University of Minnesota, 1984
  • M.S., Biometry, University of Minnesota, 1970

Expertise:

Biostatistics, Clinical Trials, Global Health, Infectious Disease: HIV / AIDS, Infectious Disease: Influenza, Research Methods

See Video: Why Jim Neaton Does What He Does

Professional Experience:

  • Professor, Biostatistics Division, School of Public Health, University of Minnesota, 1995-Present
  • Adjunct Professor of Infectious Disease & International Health, Department of Medicine
  • Associate Professor, Biostatistics Division, School of Public Health, University of Minnesota, 1990-1995
  • Assistant Professor, Biostatistics Division, School of Public Health, University of Minnesota, 1985-1990
  • Research Fellow, Biometry Division, School of Public Health, University of Minnesota, 1973-1985
  • USPHS Officer, National Heart and Lung Institute, NIH, 1970-1972

Honors:

  • Pi Mu Epsilon
  • Delta Omega Honorary Public Health Society
  • Leonard M. Schuman Excellence in Teaching Award
  • Fellow, American Statistical Association
  • Fellow, Society for Clinical Trials
  • University of Minnesota Academic Health Center Academy for Excellence in Health Research

Research Projects

Biological & Clinical Efficacy of Subcutaneous Recombinant Human Interleukin-2 in HIV-Infected Patients with Low CD4+ Counts Under Active Antiretroviral Therapy
Principal Investigator: James D. (Jim) Neaton
Funding Agency: Novartis Pharmaceuticals Corporation
Biological & Clinical Efficacy of Subcutaneous Recombinant Human Interleukin-2 in HIV-Infected Patients with Low CD4+ Counts Under Active Antiretroviral Therapy

Coordinating Center for SILCAAT Study
Principal Investigator: James D. (Jim) Neaton
Funding Agency: Chiron and the National Institutes of Health

ESPRIT Research Support
Principal Investigator: James D. (Jim) Neaton
Funding Agency: Novartis Pharmaceuticals Corporation
ESPRIT Research Support

Flu Study
Principal Investigator: James D. (Jim) Neaton
Funding Agency: Science Applications International Corp.
Flu Study

GBV-C effects on CD4 activation and expansion
Principal Investigator: James D. (Jim) Neaton
Funding Agency: The University of Iowa
GBV-C effects on CD4 activation and expansion

INSIGHT Admin Supplement: Biomarker Studies on the Patho
Principal Investigator: James D. (Jim) Neaton
Funding Agency: NIH Nat’l Inst of Allergy & Infect Dis
INSIGHT Admin Supplement: Biomarker Studies on the Patho

INSIGHT Leadership Group
Principal Investigator: James D. (Jim) Neaton
Funding Agency: NIAID, NIH
The International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) is a worldwide collaborative clinical trials network that conducts research in the area of optimization of HIV management and co-morbidities. Background: INSIGHT is a merger of two existing clinical trials research groups, ESPRIT (Evaluation of Subcutaneous Proleukin? in a Randomized Clinical Trial) established in 1999 and the CPCRA (Terry Beirn Community Programs for Clinical Research on AIDS) established in 1989 which initiated the Strategies for Management of Antiretroviral Therapy (SMART) study in 2002. The network is currently conducting research in 36 countries. INSIGHT??s mission is to conduct studies in the area of optimization of clinical management of HIV, including co-morbidities. INSIGHT will evaluate strategies for using antiretroviral therapies (ART) and immunomodulatory therapies and study interventions to prevent and treat complications of HIV and ART in order to prolong disease-free survival in a demographically, geographically, and socio-economically diverse population of individuals infected with HIV. INSIGHT will conduct large randomized trials with morbidity and mortality outcomes, preceded, where appropriate, by vanguard (smaller pilot) studies to refine design parameters. INSIGHT studies will be designed to be relevant to both resource-abundant and resource-constrained countries. Studies will be directed at understanding how to minimize the adverse effects of long-term treatment, while maximizing treatment benefits. Sub-studies will be conducted as part of larger trials. The large trials conducted by INSIGHT also provide a significant body of data for epidemiological analyses using the combined database of several trials. In addition, nested case-control studies that take advantage of the large cross-study database with clinical outcomes and the associated specimen repositories will be carried out. INSIGHT plans to foster relationships with other the networks, other institutes at NIH, and international groups in order to maximize efficiency and research productivity. Trials carried out by INSIGHT will help inform clinical practice.

International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
Principal Investigator: James D. (Jim) Neaton
Funding Agency: NIH Nat’l Inst of Allergy & Infect Dis
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)

International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
Principal Investigator: James D. (Jim) Neaton
Funding Agency: NIH Nat’l Inst of Allergy & Infect Dis
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)

International Trial of IL-2
Principal Investigator: James D. (Jim) Neaton
Funding Agency: NIAID, NIH
ESPRIT is an international trial to determine whether subcutaneous IL-2 delays progression to AIDS and extends survival among HIV infected individuals taking antiretroviral therapy. A total of 4,150 patients have been enrolled are being followed by several hundred sites in 25 countries. ESPRIT funding and management is now part of INSIGHT.

Statistical Center and Data Management Center for Community Programs for Clinical Research on AIDS
Principal Investigator: James D. (Jim) Neaton
Funding Agency: NIAID, NIH
The Community Programs for Clinical Research on AIDS (CPCRA) evaluates strategies to treat HIV in sites that provide HIV primary care. Over 50 major trials have been conducted. CPCRA funding and management is now part of INSIGHT.

Strategic Timing of AntiRetroviral Treatment Bone Mineral Density Substudy (START BMD)
Principal Investigator: James D. (Jim) Neaton
Investigators: Kristine Ensrud
Funding Agency: National Institute of Allergy and Infectious Diseases (NIAID)
The main goal of this substudy is to examine the effect of untreated HIV versus early antiretroviral therapy on bone mineral density in HIV-infected adults with high CD4 cell counts.

Selected Publications:

  • The Strategies for Management of Antiretroviral Therapy (SMART) Study Group. CD4+ count – guided interruption of antiretroviral treatment. N Engl J Med 355:2283-2296,2006.
  • The Strategies for Management of Antiretroviral Therapy (SMART) Study Group.  Clinical outcomes in the SMART study after recommendation to re-initiate antiretroviral therapy for participants randomized to the CD4+ guided interruption strategy. Ann Intern Med 149:289-299, 2008.
  • Stamler J, Neaton JD. The Multiple Risk Factor Intervention Trial (MRFIT) – Importance then and now. JAMA 300:1344-1347, 2008.
  • Kuller LH, Tracy R, Belloso W, DeWit S, Drummond F, Lane HC, Ldergerber B, Lundgren J, Neuhaus J, Nixon D, Paton NI, Neaton JD. Activation of inflammatory and coagulation pathways is associated with mortality in patients with HIV infection. PLoS Medicine 5:e203, 2008.
  • Phillips AN, Neaton J, Lundgren J. The role of HIV in serious Diseases other than AIDS. AIDS 22:2409-2418, 2008.
  • Duprez DA, Kuller LH, Tracy R, Otvos J, Cooper D, Hoy J, Neuhaus J, Paton NI, Friis-Moler N, Liappis A, Neaton JD. Lipoprotein particle subclasses, cardiovascular disease and HIV infection. Atherosclerosis 207:524-529, 2009.
  • INSIGHT ESPRIT Study Group and SILCAAT Scientific Committee. Interleukin-2 therapy in patients with HIV infection. N Engl J Med 361:1548-1559, 2009.
  • Konstam MA, Neaton JD, Dickstein K, Drexler H, Komajda M, et al. Effects of high-dose versus low-dose losartan on clinical outcomes in patients with heart failure (HEAAL study): a randomized, double-blind trial. Lancet 374:1840-1848, 2009.
  • Neuhaus J, Jacobs DR, Jr., Baker JV, Calmy A, Duprez D, LaRosa A, Kuller LH, Pett S, Ritsola M, Ross MJ, Shlipak MG, Tracy R, Neaton JD.  Markers of Inflammation, coagulation and renal function are elevated in adults with HIV infection. J Infect Dis 201:1788-1795, 2010.
  • Phidisa II Writing Team for Project Phidisa.  A randomized factorial trial comparing 4 treatment regimens in treatment-naïve HIV-infected persons with AIDS and/or < 200 CD4+ cells/µL in South Africa. J Infect Dis 202:1529-1537, 2010.
  • Baker JV, Neuhaus J, Duprez D, Kuller lH, Tracy R, Belloso WH, De Wit S, Drummond F, Lane HC, Ledergerber B, Lundgren J, Nixon DE, Paton NI, Neaton JD.  Changes in inflammatory and coagulation biomarkers:  a randomized comparison or immediate versus deferred antiretroviral therapy in patients with HIV infection. J Acquir Defic Syndr 56:36-43, 2011.
  • Misrak G, DeGruttola V, Dixon D, Essex M, Halloran E, Hogan J, Grobler A, Kim S, McDermott J, McKaig R, Neaton JD.  Strengthening biostatistics resources in Sub-Saharan Africa:  research considerations through U.S. partnerships. Stat Med  30: 695-708, 2011.
  • Morrison BW, Cochran CJ, White JG, Harley J, Kleppinger CF, Liu A, Mitchel JT, Nickerson DF, Zacharias CR, Kramer JM, Neaton JD.  Monitoring the quality of conduct of clinical trials: a survey of current practices. Clinical Trials 8:342-349, 2011.
  • INSIGHT Influenza Study Group.  Surveillance of illness associated with pandemic (H1N1) 2009 virus infection among adults using a global clinical site network approach: the INSIGHT FLU 002/FLU 003 Studies.  Vaccine 295:B56-B62, 2011.