A Sequential Phase 2b Trial Design for Evaluating Vaccine Efficacy and Immune Correlates for Multiple HIV Vaccine Regimens
暂无分享,去创建一个
Peter B Gilbert | Lawrence Corey | Steven G Self | Ying Huang | S. Hammer | J. Kublin | S. Self | S. Buchbinder | P. Gilbert | L. Corey | G. Gray | E. Gabriel | Susan P Buchbinder | Douglas Grove | Scott M Hammer | Glenda Gray | James Kublin | Erin Gabriel | D. Grove | Ying Huang
[1] Bryan Langholz,et al. Exposure Stratified Case-Cohort Designs , 2000, Lifetime data analysis.
[2] R. Gray,et al. A general inefficacy interim monitoring rule for randomized clinical trials , 2010, Clinical trials.
[3] Peter B Gilbert,et al. ASSESSING SURROGATE ENDPOINTS IN VACCINE TRIALS WITH CASE-COHORT SAMPLING AND THE COX MODEL. , 2008, The annals of applied statistics.
[4] S. Plotkin,et al. Vaccines: correlates of vaccine-induced immunity. , 2008, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.
[5] T. Fleming,et al. Adaptive Methods: Telling “The Rest of the Story” , 2010, Journal of biopharmaceutical statistics.
[6] M. Davidian,et al. Covariate adjustment for two‐sample treatment comparisons in randomized clinical trials: A principled yet flexible approach , 2008, Statistics in medicine.
[7] S. Pocock. Group sequential methods in the design and analysis of clinical trials , 1977 .
[8] Michael G Hudgens,et al. Evaluating Candidate Principal Surrogate Endpoints , 2008, Biometrics.
[9] T. Lumley,et al. Sensitivity analyses comparing time-to-event outcomes only existing in a subset selected post-randomization, conditional on covariates, with application to HIV vaccine trials , 2007 .
[10] Michael R Kosorok,et al. Simultaneous Inferences on the Contrast of Two Hazard Functions with Censored Observations , 2002, Biometrics.
[11] Anastasios A. Tsiatis,et al. Improving the efficiency of the log-rank test using auxiliary covariates , 2008 .
[12] P. Gilbert,et al. Recombinant gp120 Vaccine-Induced Antibodies Inhibit Clinical Strains of HIV-1 in the Presence of Fc Receptor-Bearing Effector Cells and Correlate Inversely with HIV Infection Rate1 , 2007, The Journal of Immunology.
[13] Dean Follmann,et al. Augmented Designs to Assess Immune Response in Vaccine Trials , 2006, Biometrics.
[14] Thomas R Fleming,et al. Standard versus adaptive monitoring procedures: a commentary , 2006, Statistics in medicine.
[15] Alan S. Perelson,et al. The first T cell response to transmitted/founder virus contributes to the control of acute viremia in HIV-1 infection , 2009, The Journal of experimental medicine.
[16] D. Siegmund. Sequential Analysis: Tests and Confidence Intervals , 1985 .
[17] S. Buchbinder,et al. Overview of STEP and Phambili trial results: two phase IIb test-of-concept studies investigating the efficacy of MRK adenovirus type 5 gag/pol/nef subtype B HIV vaccine , 2010, Current opinion in HIV and AIDS.
[18] Joseph F Heyse,et al. Evaluating the safety of a rotavirus vaccine: the REST of the story , 2008, Clinical trials.
[19] Marie Davidian,et al. Improving Efficiency of Inferences in Randomized Clinical Trials Using Auxiliary Covariates , 2008, Biometrics.
[20] J. Robins,et al. Identifiability and Exchangeability for Direct and Indirect Effects , 1992, Epidemiology.
[21] Roderick J. A. Little,et al. Adjusting for Nonignorable Drop-Out Using Semiparametric Nonresponse Models: Comment , 1999 .
[22] Punnee Pitisuttithum,et al. Randomized, double-blind, placebo-controlled efficacy trial of a bivalent recombinant glycoprotein 120 HIV-1 vaccine among injection drug users in Bangkok, Thailand. , 2006, The Journal of infectious diseases.
[23] P. Rosenbaum. The Consequences of Adjustment for a Concomitant Variable that Has Been Affected by the Treatment , 1984 .
[24] R. Betensky. Construction of a continuous stopping boundary from an alpha spending function. , 1998, Biometrics.
[25] S. Nolte,et al. Prevention of HIV infection in women. , 1993, Journal of obstetric, gynecologic, and neonatal nursing : JOGNN.
[26] S. Self,et al. Analytic Insights Into the Population Level Impact of Imperfect Prophylactic HIV Vaccines , 2007, Journal of acquired immune deficiency syndromes.
[27] P A Lachenbruch,et al. Intent-to-treat analysis and preventive vaccine efficacy. , 2000, Vaccine.
[28] K. K. Lan,et al. Discrete sequential boundaries for clinical trials , 1983 .
[29] G. Churchyard,et al. P15-08. Did unblinding affect HIV risk behaviour and risk perception in the HVTN503/Phambili study? , 2009, Retrovirology.
[30] Kenneth H Mayer,et al. Placebo-controlled phase 3 trial of a recombinant glycoprotein 120 vaccine to prevent HIV-1 infection. , 2005, The Journal of infectious diseases.
[31] Scott S Emerson,et al. Issues in the use of adaptive clinical trial designs , 2006, Statistics in medicine.
[32] J. Robins,et al. Adjusting for Nonignorable Drop-Out Using Semiparametric Nonresponse Models , 1999 .
[33] David L. DeMets,et al. Data Monitoring Committees in Clinical Trials: A Practical Perspective , 2002 .
[34] R. Anderson,et al. Low-efficacy HIV vaccines: potential for community-based intervention programmes , 1996, The Lancet.
[35] J. Swinton,et al. Potential impact of low efficacy HIV-1 vaccines in populations with high rates of infection , 1995, Proceedings of the Royal Society of London. Series B: Biological Sciences.
[36] M J van der Laan,et al. Covariate adjustment in randomized trials with binary outcomes: Targeted maximum likelihood estimation , 2009, Statistics in medicine.
[37] N. Binding,et al. Hepatitis A and hepatitis B vaccinations: immunogenicity of combined vaccine and of simultaneously or separately applied single vaccines. , 2000, Vaccine.
[38] Devan V Mehrotra,et al. Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial , 2008, The Lancet.
[39] P. O'Brien,et al. A multiple testing procedure for clinical trials. , 1979, Biometrics.
[40] Jerome H. Kim,et al. Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand. , 2009, The New England journal of medicine.
[41] D. Rubin,et al. Principal Stratification in Causal Inference , 2002, Biometrics.
[42] Peter B Gilbert,et al. Evaluating a surrogate endpoint at three levels, with application to vaccine development , 2008, Statistics in medicine.
[43] T R Fleming,et al. Symmetric group sequential test designs. , 1989, Biometrics.
[44] J. Lieberman,et al. A Sound Rationale Needed for Phase III HIV-1 Vaccine Trials , 2004, Science.
[45] Peter B Gilbert,et al. A framework for assessing immunological correlates of protection in vaccine trials. , 2007, The Journal of infectious diseases.
[46] Peter B. Gilbert,et al. Increasing the Efficiency of Prevention Trials by Incorporating Baseline Covariates , 2010, Statistical communications in infectious diseases.
[47] Ian W McKeague,et al. The 2-sample problem for failure rates depending on a continuous mark: an application to vaccine efficacy. , 2007, Biostatistics.
[48] Julian Wolfson,et al. Statistical Identifiability and the Surrogate Endpoint Problem, with Application to Vaccine Trials , 2010, Biometrics.