Statistics Collaborative - Design and analysis for biomedical research


Janet Wittes

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  • Buhr KA, Downs M, Rhorer J, Bechhofer R, Wittes J. Reports to independent data monitoring committees: An appeal for clarity, completeness, and comprehensibility. Therapeutic Innovation and Regulatory Science 2018; 52:459-468.

  • Russell S, Bennett J, Wellman JA, Chung DC, Yu ZF, Tillman A, Wittes J, Pappas J, Elci O, McCague S, Cross D, Marshall KA, Walshire J, Kehoe TL, Reichert H, Davis M, Raffini L, George LA, Hudson FP, Dingfield L, Zhu X, Haller JA, Sohn EH, Mahajan VB, Pfeifer W, Weckmann M, Johnson C, Gewaily D, Drack A, Stone E, Wachtel K, Simonelli F, Leroy BP, Wright JF, High KA, Maguire AM. Efficacy and safety of voretigene neparvovec (AAV2-hRPE65v2) in patients with RPE65-mediated inherited retinal dystrophy: A randomised, controlled, open-label, phase 3 trial. Lancet 2017.

  • Packer M, O'Connor C, McMurray JJ, Wittes J, Abraham WT, Anker SD, Dickstein K, Filippatos G, Holbomb R, Krum H, Maggioni AP, Mebazaa A, Peacock WF, Petrie MC, Ponikowski P, Ruschitzka F, van Veldhuisen DJ, Kowarski LS, Schactman M, Holzmeister J, TRUE-AHF Investigators. Effect of ularitide on cardiovascular mortality in acute heart failure. N Engl J Med 2017; 376:1956-1964.

  • Rossignol P, Agarwal R, Canaud B, Charney A, Chatellier G, Craig J, Cushman WC, Gansevoort RT, Fellström B, Garza D, Guzman N, Holtkamp F, London GM, Massy ZA, Mebazaa A, Mol PCM, Pfeffer MA, Rosenberg Y, Ruilope LM, Seltzer J, Shah AM, Shah S, Singh B, Stefánsson BV, Stockbridge N, Stough WG, Thygesen K, Walsh M, Wanner C, Warnock DG, Wilcox CS, Wittes J, Pitt B, Thompson A, Zannad F. Cardiovascular outcome trials in patients with chronic kidney disease: Challenges associated with selection of patients and endpoints. European Heart Journal; to appear in 2017.

  • Fleming TR, DeMets DL, Roe MT, Wittes J, Calis KA, Vora AN, Meisel A, Bain RP, Konstam MA, Pencina MJ, Gordon DJ, Mahaffey KW, Hennekens CH, Neaton JD, Pearson GD, Andersson TLG, Pfeffer MA, Ellenberg SS. Data monitoring committees: Promoting best practices to address emerging challenges. Clin Trials 2017; 14:115-123.

  • Yusuf S, Wittes J. Interpreting Geographic variations in results of randomized, controlled trials. N Engl J Med 2016; 375:2263-2271.

  • Zannad F, Rossignol P, Stough WG, Epstein M, Garcia MAA, Bakris GL, Butler J, Kosiborod M, Berman L, Mebazzaa A, Rasmussen HS, Ruilope LM, Stockbridge N, Thompson A, Wittes J, Pitt B. New approaches to hyperkalemia in patients with indications for renin angiotensin aldosterone inhibitors: Considerations for the trial design and regulatory approval. International Journal of Cardiology 2016; 216:46-51.

  • Jackson T, Desai R, Simpson A, Neffendorf J, Petrarca R, Smith K, Wittes J, Lewis C, Membrey L, Haynes R, Costen M, Steel D, Muldrew A, Chakravarthy, U. Epimacular brachytherapy for previously treated neovascular agerelated macular degeneration (MERLOT): a randomized controlled trial. Ophthalmology 2016; 123: 1287 – 1296.
  • Little R, Wang J, Sun X, Tian H, Suh E, Lee M, Sarich T, Oppenheimer L, Plotnikov A, Wittes J, Cook-Bruns N, Burton P, Gibson M, Mohanty S. The treatment of missing data in a large cardiovascular clinical outcomes study. Clinical Trials 2016; 13: 344 – 351.
  • Wittes J. Independent data monitoring committees in multiregional clinical trials. In: Chen J, Quan H, ed. Multi-Regional Clinical Trials for Simultaneous Global New Drug Development. Boca Raton, FL:
    CRC Press, to appear 2016.
  • Bierer B, Li R, Seltzer J, Sleeper L, Frank E, Knirsch C, Aldinger C, Levine R, Massaro J, Shah A, Barnes M, Snapinn S, Wittes J. Responsibilities of Data Monitoring Committees: Consensus Recommendations. Therapeutic Innovation & Regulatory Science 2016; 1-12.
  • Wittes J. Commentary on Murray and Hernán paper. Clin Trials 2016; 1:1-3.
  • DeMets DL, Wittes JT, Geller NL. The influence of biostatistics at the National Heart, Lung, and Blood Institute. The American Statistician 2015; 69:108-120 DOI:10.1080/00031305.2015.1035962.
  • Schmidinger M, Wittes J. First-line treatment of metastatic renal cell carcinoma after COMPARZ and PISCES. Curr Opin Urol 2015; 25:395-401.
  • Uno H, Wittes J, Fu H, Solomon SD, Claggett B, Tian L, Cai T, Pfeffer MA, Evans SR, Wei LJ. Alternatives to hazard ratios for comparing the efficacy or safety of therapies in noninferiority studies. Ann Intern Med 2015; 163:127-134.
  • Weir MR, Bakris GL, Bushinsky DA, Mayo MR, Garza D, Stasiv Y, Wittes J, Christ-Schmidt H, Berman L, Pitt B. Patiromer in patients with kidney disease and hyperkalemia receiving RAAS Inhibitors. N Engl J Med 2015; 372:211-221.
  • Wittes J, Crowe B, Chuang-Stein C, Guettner A, Hall D, Odenheimer D, Xi HA, Kramer J. The FDA's final rule on expedited safety reporting: Statistical considerations. Stat Biopharm Res 2015; 7:174-190.
  • Wittes J, Musch DC. Should we test for genotype in deciding on age-related eye disease study supplementation. Ophthalmology 2015; 122:3-5.
  • Chin MP, Wrolstad D, Bakris GL, Chertow GM, de Zeeuw D, Goldsberry A, Linde PG, McCullough PA, McMurray JJ, Wittes J, Meyer CJ. Risk factors for heart failure in patients with type 2 diabetes mellitus and stage 4 chronic kidney disease treated with Bardoxolone Methyl. J Card Fail 2014; 20:953-958.
  • Moukarbel GV, Yu Z, Dickstein K, Hou YR, Wittes JT, McMurray JJV, Pitt B, Zannad F, Pfeffer MA, Solomon S. The impact of kidney function on outcomes following high-risk myocardial infarction: findings from 27,610 patients. Eur J Heart Fail 2014; 16:289-299.
  • Schactman M, Wittes J. Why a DMC safety report differs from a safety section written at the end of a trial. In: Jiang Q, Xia HA, ed. Quantitative Evaluation of Safety Drug Development: Design, Analysis, and Reporting. Boca Raton, FL: Chapman and Hall/CRC, 2014.
  • Wittes J. Assessing correlates of protection in vaccine trials. J Infect Dis 2014; 210:1523-1525.
  • Wittes J, Schactman M. On independent data monitoring committees in oncology clinical trials. Chinese Clinical Oncology, 2014; 10.3978/j.issn.2304-3865.2014.3906.3901.
  • 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.
  • de Zeeuw D, Akizawa T, Audhya P, Bakris GL, Chin M, Christ-Schmidt H, Goldsberry A, Houser M, Krauth M, Lambers Heerspink HJ, McMurray JJ, Meyer CJ, Parving HH, Remuzzi G, Toto RD, Vaziri ND, Wanner C, Wittes J, Wrolstad D, Chertow GM. Bardoxolone methyl in type 2 diabetes and stage 4 chronic kidney disease. N Engl J Med 2013; 369:2492-2503.
  • Lambers Heerspink HJ, Chertow GM, Akizawa T, Audhya P, Bakris GL, Goldsberry A, Krauth M, Linde P, McMurray JJ, Meyer CJ, Parving HH, Remuzzi G, Christ-Schmidt H, Toto RD, Vaziri ND, Wanner C, Wittes J, Wrolstad D, de Zeeuw D. Baseline characteristics in the Bardoxolone methyl EvAluation in patients with Chronic kidney disease and type 2 diabetes mellitus: the Occurrence of renal eveNts (BEACON) trial Nephrol Dial Transplant 2013; 28:2841-2850.
  • Wittes J. Pazopanib versus sunitinib in renal cancer. N Engl J Med 2013; 369:1969.

  • 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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