Statistics Collaborative - Design and analysis for biomedical research

PublicationsPublications

Janet Wittes

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  • Sadoff JC, Wittes J. Correlates, surrogates, and vaccines. J Infect Dis 2007; 196:1279-1281.
  • Lachenbruch PA, Wittes J. Sentinel events methods for monitoring unanticipated adverse events. In Auget JL, Balakrishnan N, Mesbah M (eds). Advances in Statistical Methods for the Health
    Sciences
    . Birkhauser: 2007 61-74.
  • Borer JS, Pouleur H, Abadie E, Follath F, Wittes J, Pfeffer MA, Pitt B, Zannad F. Cardiovascular safety of drugs not intended for cardiovascular use: need for a new conceptual basis for assessment and approval. Eur Heart J 2007; 28:1904-1909.
  • Withers MR, McKinney D, Ogutu BR, Waitumbi JN, Milman JB, Apollo OJ, Allen OG, Tucker K, Soisson LA, Diggs C, Leach A, Wittes J, Dubovsky F, Stewart VA, Remich SA, Cohen J, Ballou WR, Holland CA, Lyon JA, Angov E, Stoute JA, Martin SK, Heppner DG, Jr. Safety and reactogenicity of an MSP-1 malaria vaccine candidate: a randomized phase Ib dose-escalation trial in Kenyan children. PLoS Clin Trials 2006; 1:e32.
  • Gorse G, O’Connor T, Young S, Habib M, Wittes J, Neuzil K, Nichol K. Impact of a winter respiratory virus season on patients with COPD and association with influenza vaccination. Chest 2006; 130:1109-1116.
  • Bertagnolli M, Eagle C, Zauber AG, Redston M, Solomon SD, Kim K, Tang J, Rosenstein R, Wittes J, Corle D, Hess T, Woloj M, Boisserie F, Anderson W, Viner J, Bagheri DB, J, Chung D, Dewar T, Foley R, Hoffman N, Macrae F, Pruitt RE, Saltzman J, Salzberg B, Sylwestrowicz T, Gordon G, Hawk E. Celecoxib for the prevention of sporadic colorectal adenomas. N Engl J Med 2006; 355:873-884.
  • Arber N, Eagle C, Spicak J, Racz I, Dite P, Hajer J, Zavoral M, Lechuga M, Gerletti P, Tang J, Rosenstein R, Macdonald K, Bhadra P, Fowler R, Wittes J, Zauber AG, Solomon SD, Levin B. Celecoxib for the prevention of colorectal adenomatous polyps. N Engl J Med 2006; 355:885-895.
  • Solomon S, Pfeffer M, McMurray J, Fowler R, Finn P, Levin B, Eagle C, Hawk E, Lechuga M, Zauber A, Bertagnolli M, Arber N, Wittes J. Effect of celecoxib on cardiovascular events and blood pressure in two trials for the prevention of colorectal adenomas. Circulation 2006; 114:1028-1035.
  • Wittes J. A tale of three species – rabbits, chickens and humans: an interview with clinical trials pioneer Jeremiah Stamler. Clin Trials 2006; 3:320-334.
  • Harmatz P, Giugliani R, Schwartz I, Guffon N, Teles EL, Miranda M, Wraith J, Beck M, Arash L, Scarpa M, Yu Z, Wittes J, Berger K, Newman M, Lowe A, Kakkis E, Swiedler S, MPS VI Phase 3 Study Group. Enzyme replacement therapy for Mucopolysaccharidosis VI: a phase 3, randomized, double-blind, placebo-controlled, multinational study of recombinant human n-acetylgalactosamine 4‑sulfatase (recombinant human arylsulfatase B or rhASB) and follow-on, open-label extension study. J Pediatr 2006; 148:533-539.
  • Kaizar E, Greenhouse J, Seltman H, Kelleher K. Discussion: Do antidepressants cause suicidality in children? A Bayesian meta-analysis. Clin Trials 2006; 3:73-98.
  • Wittes J, Lachenbruch P. Opening the adaptive toolbox. Biometrical J 2006; 48:598-603.
  • Lachenbruch P, Wittes J. Some aspects of the application of internal pilot studies. Biometrical J, 2006; 48:556-557.
  • Solomon S, Wittes J, Arber N, Bertagnolli M, Hawk E, Levin B. Risks and benefits of celecoxib to prevent colorectal adenomas. N Engl J Med 2006; Authors’ reply to letter: 2371-2373.
  • Proschan M, Lan K, Wittes J. Statistical Monitoring of Clinical Trials: A Unified Approach. New York: Springer, 2006.
  • Wittes J, Holmgren E, Christ-Schmidt H, Bajamonde A. Making independence work: monitoring the bevacizumab colorectal cancer clinical trial. In DeMets D, Furberg C, Friedman L (eds). Data Monitoring in Clinical Trials, A Case Studies Approach. Springer, 360-367, 2006.
  • Pocock S, Wilhelmsen L, Dickstein K, Francis G, Wittes J. Data monitoring experience in the Moxonidine Congestive Heart Failure Trial. In DeMets D, Furberg C, Friedman L (eds). Data Monitoring in Clinical Trials, A Case Studies Approach. Springer, 260-268, 2006.
  • Wittes J, Boissel J, Furberg C, Julian D, Kulbertus H, Pocock S. Stopping the Randomized Aldactone Evaluation Study early for efficacy. In DeMets D, Furberg C, Friedman L (eds). Data Monitoring in Clinical Trials, A Case Studies Approach. Springer, 148-157, 2006.
  • Black HR, Elliott WJ, Grandits G, Grambsch P, Lucente T, Neaton JD, Grimm RH, Hansson L, Lacouciere Y, Muller JE, Sleight P, Weber MA, White WB, Williams GH, Wittes J, Zanchetti A, and , Anders R, for the CONVINCE Research Group. Results of the Controlled ONset of Verapamil INvestigation of Cardiovascular Endpoints (CONVINCE) trial by geographical region. J Hypertens 2005; 23:1099-1106.
  • Heppner DG, Jr., Kester KE, Ockenhouse CF, Tornieporth N, Ofori O, Lyon JA, Stewart VA, Dubois P, Lanar DE, Krzych U, Moris P, Angov E, Cummings JF, Leach A, Hall BT, Dutta S, Schwenk R, Hillier C, Barbosa A, Ware LA, Nair L, Darko CA, Withers MR, Ogutu B, Polhemus ME, Fukuda M, Pichyangkul S, Gettyacamin M, Diggs C, Soisson L, Milman J, Dubois MC, Garcon N, Tucker K, Wittes J, Plowe CV, Thera MA, Duombo OK, Pau MG, Goudsmit J, Ballou WR, Cohen J. Towards an RTS,S-based, multi-stage, multi-antigen vaccine against falciparum malaria: progress at the Walter Reed Army Institute of Research. Vaccine 2005; 23:2243-2250.

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