Statistics Collaborative - Design and analysis for biomedical research

PublicationsPublications

Janet Wittes

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  • Mathew J, Wittes J, McSherry F, Williford W, Garg R, Probstfield J, Yusuf S, Digitalis Investigation Group. Racial differences in outcome and treatment effect in congestive heart failure. Am Heart J 2005; 150:968-976.
  • Villahermosa L, Fajardo T, Abalos R, Balagon M, Tan E, Cellona R, Palmer J, Wittes J, Thomas S, Kook K, Walsh G, Walsh D. A randomized, double-blind, double-dummy, controlled dose comparison of thalidomide for treatment of erythema nodosum leprosum. Am J Trop Med Hyg 2005; 75:518-526.
  • Solomon S, Wittes J, McMurray J. Letter: Cardiovascular risk associated with celecoxib. New Engl J Med 2005; 352:2648-2650.
  • Wittes J. Adaptive designs for clinical trials. P Armitage, T Colton (eds). Encyclopedia of Biostatistics, Second Edition. New York: John Wiley, 1:51-55, 2005.
  • Wittes J. Discussion of a paper by Sampson and Sill. Biometrical J, 2005; 47:276-277.
  • DeMets D, Fleming T, Rockhold F, Massie B, Merchant T, Meisel A, Mishkin B, Wittes J, Stump D, Califf R. Liability issues for data monitoring committee members. Clin Trials 2004; 1:525-531.
  • Gorse G, O’Connor T, Newman F, Mandava M, Mendelman P, Wittes J, Peduzzi P. Immunity to influenza in older adults with chronic obstructive pulmonary disease. J Infect Dis 2004; 190:11-19.
  • Pocock S, Wilhelmsen L, Dickstein K, Francis G, Wittes J. The data monitoring experience in the MOXCON trial. Eur Heart J 2004; 25:1974-1978.
  • Wittes J. Playing safe and preserving integrity: making the FDA model work. Stat Med 2004; 23:1523-1525.
  • Wittes J. Forming your phase III trial’s Data and Safety Monitoring Board: a perspective on safety. J Investig Med 2004; 52:453-458.
  • Black H, Elliott W, Grandits G, Grambsch P, Lucente T, White W, Neaton J, Grimm R, Hansson L, Lacouciere Y, Muller J, Sleight P, Weber M, Williams G, Wittes J, Zanchetti A, Anders R. Principal results of the controlled onset Verapamil investigation of cardiovascular end points (CONVINCE) trial. JAMA 2003; 289:2073-2082.
  • Califf R, Morse M, Wittes J, Goodman S, Nelson D, DeMets D, Iafrate R, Sugarman J. Towards protecting the safety of participants in clinical trials. Control Clin Trials 2003; 24:256-271.
  • Gorse G, O’Connor T, Young S, Mendelman P, Bradley S, Nichol K, Strickland J, Paulson D, Rice K, Foster R, Fulambarker A, Shigeoka J, Kuschner W, Goodman R, Neuzil K, Wittes J, Boardman K, Peduzzi P. Efficacy trial of live, cold-adapted and inactivated influenza virus vaccines in older adults with chronic obstructive pulmonary disease: a VA cooperative study. Vaccine 2003; 21:2133-2144.
  • Wittes J. On changing a long-term clinical trial midstream. Stat Med 2002; 21:2789-2795.
  • Althuis M, Jordan N, Ludington E, Wittes J. Glucose and insulin responses to dietary chromium supplements: a meta-analysis. Am J Clin Nutr 2002; 76:148-155.
  • Wittes J. Sample size calculations for randomized controlled trials. Am J Epidemiol 2002; 24:39-53.
  • Nyman J, Martinson M, Nelson D, Nugent S, Collins D, Wittes J, Wilt T, Robins S, Rubins H. Cost-effectiveness of Gemfibrozil for coronary heart disease patients with low levels of high-density lipoprotein cholesterol. Arch Intern Med 2002; 162:177-182.
  • Wittes J. The use of soft endpoints in clinical trials: the search for clinical significance. Chapter 8 in Mesbah, et al. Statistical Methods for Quality of Life Studies. Design, Measurements and Analysis. Netherlands: Kluwer Academic Publishers, 129-140, 2002.
  • Packer M, Wittes J, Stump D. Terms of reference for Data and Safety Monitoring Committees. Am Heart J 2001; 141:542-547.
  • De Gruttola V, Clax P, DeMets D, Downing G, Ellenberg S, Friedman L, Gail M, Prentice R, Wittes J, Zeger S. Considerations in the evaluation of surrogate endpoints in clinical trials: summary of a National Institutes of Health Workshop. Control Clin Trials 2001; 22:485-502.

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