Statistics Collaborative - Design and analysis for biomedical research

PublicationsPublications

Janet Wittes

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  • de Zeeuw D, Akizawa T, Agarwal R, Audhya P, Bakris GL, Chin M, Krauth M, Lambers Heerspink HJ, Meyer CJ, McMurray JJ, Parving HH, Pergola PE, Remuzzi G, Toto RD, Vaziri ND, Wanner C, Warnock DG, Wittes J, Chertow GM. Rationale and trial design of bardoxolone methyl evaluation in patients with chronic kidney disease and type 2 diabetes: the occurrence of renal events (BEACON). Am J Nephrol 2013; 37:212-222.
  • Wittes J. Why is this subgroup different from all other subgroups? Thoughts on regional differences in randomized clinical trials. Proceedings of the Fourth Seattle Symposium in Biostatistics: Clinical Trials, Seattle, WA, 2013.

  • Bebchuk J, Wittes J. Fundamentals of Biostatistics. In: Ravina B, ed. Clinical Trials in Neurology: Design, Conduct, Analysis. Cambridge, New York: Cambridge University Press, 28-41, 2012.

  • Coffey CS, Levin B, Clark C, Timmerman C, Wittes J, Gilbert P, Harris S. Overview, hurdles, and future work in adaptive designs: perspectives from a National Institutes of Health-funded workshop. Clin Trials 2012; 9:671-680.

  • Dickstein K, Bebchuk J, Wittes J. The high-risk myocardial infarction database initiative. Prog Cardiovasc Dis 2012; 54:362-366.

  • Lan KG, Wittes JT. Some thoughts on sample size: A Bayesian-frequentist hybrid approach. Clin Trials 2012; 9:561-569.

  • Wittes J. Book review of Julious, S. A. Sample Sizes for Clinical Trials. Biometrics 2012; 68:327-328.

  • Wittes J. Clinical trials must cope better with multiplicity. Nat Med 2012; 18:1607.

  • Wittes J. Jerome Cornfield's contributions to early large randomized clinical trials and some reminiscences from the years of the slippery doorknobs. Stat Med 2012; 31:2791-2797.

  • Wittes J, Yu Z. Design and Analysis of Randomized Clinical Trials. In: Hinkelmann K, ed. Design and Analysis of Experiments. New York: John Wiley, 165-211, 2012.

  • Wittes J. Stopping a trial early – and then what? Clin Trials 2012; 9:714-720.

  • Anand SS, Wittes J, Yusuf S. What information should a sponsor of a randomized trial receive during its conduct? (with discussion and response by author). Clin Trials 2011; 8:716-726.

  • Herson J, Buyse M, Wittes J. On stopping a randomized clinical trial for futility. Designs for Clinical Trials: Perspectives on Current Issue. New York: Springer, 109-137, 2011.

  • Pergola PE, Raskin P, Toto RD, Meyer CJ, Huff JW, Grossman EB, Krauth M, Ruiz S, Audhya P, Christ-Schmidt H, Wittes J, Warnock DG. Bardoxolone methyl and kidney function in CKD with Type 2 diabetes. N Engl J Med 2011; 365:327-336.

  • Schumi J, Wittes J. Through the looking glass: understanding non-inferiority. Trials 2011; 12:106.

  • Wittes J. Discussion of paper by Korn and Freidlin. Am J Bioeth 2011; 11:13-14.

  • Wittes J, Gorin MB, Mayne ST, McCarthy CS, Sternberg P, Jr., Wall M. Letter from the DSMC regarding a clinical trial of lutein in patients with retinitis pigmentosa. Arch Ophthalmol 2011; 129:675.

  • Wittes J. Comments on the FDA draft guidance on adaptive designs. J Biopharm Stat 2010; 20:1166-1170.

  • Goodman S, Berry D, Wittes J. Bias and trials stopped early for benefit. JAMA 2010; 304:157.

  • White H, Held C, Stewart R, Watson D, Harrington R, Budaj A, Steg PG, Cannon CP, Krug-Gourley S, Wittes J, Trivedi T, Tarka E, Wallentin L. Study design and rationale for the clinical outcomes of the STABILITY Trial (STabilization of Atherosclerotic plaque By Initiation of darapLadIb TherapY) comparing darapladib versus placebo in patients with coronary heart disease. Am Heart J 2010; 160:655-661.

  • Downs M, Tucker K, Christ-Schmidt H, Wittes J. Some practical problems in implementing randomization. Clin Trials 2010; 7:235-245.

  • Kay R, Wu J, Wittes J. On assessing the presence of evaluation-time bias in progression-free survival in randomised trials. Pharm Stat 2010; 10:213-217.

  • Wittes J. Comment on paper by Crowe et al. Clin Trials 2009; 6:441-442; discussion 445.

  • Wittes J. Missing inaction: Preventing missing outcome data in randomized clinical trials. J Biopharm Stat 2009; 19:957-968.

  • Wittes J. Commentary on ‘Measurement in clinical trials: a neglected issue for statisticians?’ Stat Med 2009; 28:3220-3222.

  • Wittes J, Downs M. Outcome measures to assess efficacy of treatments for age-related macular degeneration. Ophthalmology 2009; 116:S8-14.

  • Rhorer J, Ambrose C, Dickinson S, Hamilton H, Oleka N, Malinoski F, Wittes J. Efficacy of live attenuated influenza vaccine in children: a meta-analysis of nine randomized clinical trials. Vaccine 2009; 27:1101-1110.

  • Ogutu BR, Apollo OJ, McKinney D, Okoth W, Siangla J, Dubovsky F, Tucker K, Waitumbi JN, Diggs C, Wittes J, Malkin E, Leach A, Soisson LA, Milman JB, Otieno L, Holland CA, Polhemus M, Remich SA, Ockenhouse CF, Cohen J, Ballou WR, Martin SK, Angov E, Stewart VA, Lyon JA, Heppner DG, Withers MR. Blood stage malaria vaccine eliciting high antigen-specific antibody concentrations confers no protection to young children in Western Kenya. PLoS ONE 2009; 4:e4708.

  • Kramer BS, Hagerty KL, Justman S, Somerfield MR, Albertsen PC, Blot WJ, Ballentine Carter H, Costantino JP, Epstein JI, Godley PA, Harris RP, Wilt TJ, Wittes J, Zon R, Schellhammer P. Use of 5-alpha-reductase inhibitors for prostate cancer chemoprevention: American Society of Clinical Oncology/American Urological Association 2008 Clinical Practice Guideline. J Clin Oncol 2009; 27:1502-1516.

  • Wittes J. On looking at subgroups. Circulation 2009; 119:912-915.

    Solomon SD, Wittes J, Finn PV, Fowler R, Viner J, Bertagnolli MM, Arber N, Levin B, Meinert CL, Martin B, Pater JL, Goss PE, Lance P, Obara S, Chew EY, Kim J, Arndt G, Hawk E. Cardiovascular risk of celecoxib in 6 randomized placebo-controlled trials: the cross trial safety analysis. Circulation 2008; 117:2104-2113.

  • Cairns JA, Wittes J, Wyse DG, Pogue J, Gent M, Hirsh J, Marler J, Pritchett EL. Monitoring the ACTIVE-W trial: some issues in monitoring a noninferiority trial. Am Heart J 2008; 155:33-41.

  • Wittes J. Times to event: why are they hard to visualize? J Natl Cancer I 2008; 100:80‑81.

  • Lachenbruch PA, Stablein D, Wittes J. Too quick to impugn: JAMA editorialists doubt integrity of statisticians working in for-profit world. AmStat News 2008; July:2-3.

  • Levine MM, Akinyinka OO, Breman J, Halsey N, Kendall C, Laufer M, Magill C, Moss W, Plowe C, Williams C, Wiseman V, Wittes J, Zikusooka C. Assessment of the Role of Intermittent Preventive Treatment for Malaria in Infants. Washington DC: Institute of Medicine, 2008.

  • Wittes J, Barrett-Connor E, Braunwald E, Chesney M, Cohen HJ, Demets D, Dunn L, Dwyer J, Heaney RP, Vogel V, Walters L, Yusuf S. Monitoring the randomized trials of the Women’s Health Initiative: the experience of the Data and Safety Monitoring Board. Clin Trials 2007; 4:218-234.

  • Kester KE, McKinney DA, Tornieporth N, Ockenhouse CF, Heppner DG, Jr., Hall T, Wellde BT, White K, Sun P, Schwenk R, Krzych U, Delchambre M, Voss G, Dubois MC, Gasser RA, Jr., Dowler MG, O’Brien M, Wittes J, Wirtz R, Cohen J, Ballou WR. A phase I/IIa safety, immunogenicity, and efficacy bridging randomized study of a two-dose regimen of liquid and lyophilized formulations of the candidate malaria vaccine RTS,S/AS02A in malaria-naive adults. Vaccine 2007; 25:5359-5366.

  • Stoute JA, Gombe J, Withers MR, Siangla J, McKinney D, Onyango M, Cummings JF, Milman J, Tucker K, Soisson L, Stewart VA, Lyon JA, Angov E, Leach A, Cohen J, Kester KE, Ockenhouse CF, Holland CA, Diggs C, Wittes J, Heppner DG. Phase I randomized double-blind safety and immunogenicity trial of Plasmodium falciparum malaria merozoite surface protein FMP1 vaccine, adjuvanted with AS02A, in adults in western Kenya. Vaccine 2007; 25:176-184.

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