Statistics Collaborative - Design and analysis for biomedical research

PublicationsPublications

Judith Bebchuk

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  • Trefz F, Burton B, Longo N, Casanova MM, Gruskin D, Dorenbaum A, Kakkis E, Crombez E, Grange D, Harmatz P, Levy H, Lipson M, Milanowski A, Randolph L, Vockley G, Whitley C, Wolff J, Bebchuk J, Christ-Schmidt H, Hennermann J, The Sapropterin Study Group. Efficacy of sapropterin dihydrochloride in increasing phenylalanine tolerance in children with phenylketonuria: a phase III, randomized, double-blind, placebo-controlled study. J Pediatr 2009; 154:700-707.
  • Lee P, Treacy EP, Crombez E, Wasserstein M, Waber L, Wolff J, Wendel U, Dorenbaum A, Bebchuk J, Christ-Schmidt H, Seashore M, Giovannini M, Burton BK, Morris AA, The Sapropterin Research Group. Safety and efficacy of 22 weeks of treatment with sapropterin dihydrochloride in patients with phenylketonuria. Am J Med Genet 2008; 146A:2851-2859.
  • Levy HL, Milanowski A, Chakrapani A, Cleary M, Lee P, Trefz FK, Whitley CB, Feillet F, Feigenbaum AS, Bebchuk JD, Christ-Schmidt H, Dorenbaum A. Efficacy of sapropterin dihydrochloride (tetrahydrobiopterin, 6R-BH4) for reduction of phenylalanine concentration in patients with phenylketonuria: a phase III randomised placebo-controlled study. Lancet 2007; 370:504-510.
  • Pace C, Grady C, Wendler D, Bebchuk J, Tavel J, McNay L, Forster H, Killen J, Emanuel E for the ESPIRIT Group. Post trial access to tested interventions: the views of IRB/REC chairs, investigators and research participants in a multinational HIV/AIDS study. AIDS Res Hum Retrov 2006; 22:837-841.
  • Mocroft A, Neaton J, Bebchuk J, Staszewski S, Antunes F, Knysz B, Law M, Phillips AN, Lundgren J. The feasibility of clinical endpoint trials in HIV infection in the highly active antiretroviral treatment (HAART) era. Clin Trials 2006; 206:119-132.
  • Sabik L, Pace CA, Forster-Gertner HP, Wendler D, Bebchuk JD, Tavel JA, McNay LA, Killen J, Emanuel EJ, Grady C. Informed consent: practices and views of investigators in a multinational clinical trial. IRB 2005; 27:13-18.
  • Bebchuk J, Betensky R. Tests for treatment differences in the hazards for survival before and after the occurrence of an intermediate event. Stat Med 2005; 24:359‑378.
  • Pace C, Emanuel EJ, Chuenyam T, Duncombe C, Bebchuk JD, Wendler D, Tavel JA, McNay LA, Phanuphak P, Forster HP, Grady C. The quality of informed consent in a clinical research study in Thailand. IRB 2005; 27:9-17.
  • Markowitz N, Bebchuk J, Abrams D. Nadir CD4+ T-cell count predicts response to subcutaneous recombinant interleukin-2. Clin Infect Dis 2003; 37:e115-120.
  • McNay LA, Tavel JA, Oseekey K, McDermott CM, Mollerup D, Bebchuk JD. Regulatory approvals in a large multinational clinical trial: the ESPRIT experience. Control Clin Trials 2002; 23:59-66.
  • Bebchuk J, Betensky R. Local likelihood analysis of the latency distribution with interval censored intermediate events. Stat Med 2001; 21:3475-3491.
  • Abrams D, Bebchuk J, Denning E, Davey R, Fox, L, Lane C, Sampson J, Verheggen R, Zeh D, Markowitz N. Randomized, open-label study of the impact of two doses of subcutaneous recombinant interleukin-2 on viral burden in patients with HIV-1 infection and CD4+ cell counts of ≥ 300/mm3: CPCRA 059. J Acquir Immune Defic Syndr 2002; 29:221-231.

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