Search Results - "LAIRD, Glen"
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Beyond exposure‐response: A tutorial on statistical considerations in dose‐ranging studies
Published in Clinical and translational science (01-07-2021)“…Dose‐ranging studies are a crucial part of the phase II drug development process. They complement the understanding gained from exposure‐response analyses…”
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A Phase I Study of Intravenous LBH589, a Novel Cinnamic Hydroxamic Acid Analogue Histone Deacetylase Inhibitor, in Patients with Refractory Hematologic Malignancies
Published in Clinical cancer research (01-08-2006)“…Purpose: LBH589 is a novel histone deacetylase inhibitor that inhibits proliferation and induces apoptosis in tumor cell lines. In this phase I study, LBH589…”
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A Bayesian phase II proof‐of‐concept design for clinical trials with longitudinal endpoints
Published in Statistics in medicine (15-01-2024)“…Existing phase II clinical trial designs focus on a single scalar endpoint, such as a binary, continuous, or survival endpoint. In some clinical trials, such…”
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Goodness-of-fit test for proportional subdistribution hazards model
Published in Statistics in medicine (30-09-2013)“…This paper concerns using modified weighted Schoenfeld residuals to test the proportionality of subdistribution hazards for the Fine–Gray model, similar to the…”
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Adaptive hybrid control design for comparative clinical trials with historical control data
Published in Journal of the Royal Statistical Society Series C: Applied Statistics (12-03-2024)“…We propose an adaptive hybrid control causal (AHCC) design to leverage historical control data to reduce the sample size demanded by standard randomised…”
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Design and analysis of drop-the-losers studies using binary endpoints in the rare disease setting
Published in Journal of biopharmaceutical statistics (04-07-2021)“…The drop-the-losers design combines a phase 2 trial of k treatments and a confirmatory phase 3 trial under a single adaptive protocol, thereby gaining…”
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A confirmatory basket design considering non-inferiority and superiority testing
Published in Journal of biopharmaceutical statistics (03-03-2024)“…For multiple rare diseases as defined by a common biomarker signature, or a disease with multiple disease subtypes of low frequency, it is often possible to…”
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Burden of cystic fibrosis in children <12 years of age prior to the introduction of CFTR modulator therapies
Published in BMJ open respiratory research (01-12-2021)“…BackgroundCystic fibrosis (CF) is a genetic, multisystemic, progressive and life-shortening disease caused by mutations in the CF transmembrane conductance…”
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Burden of cystic fibrosis in children
Published in BMJ open respiratory research (01-01-2021)“…Background Cystic fibrosis (CF) is a genetic, multisystemic, progressive and life-shortening disease caused by mutations in the CF transmembrane conductance…”
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Bayesian additive decision trees of biomarker by treatment interactions for predictive biomarker detection and subgroup identification
Published in Journal of biopharmaceutical statistics (04-05-2018)“…Personalized medicine, or tailored therapy, has been an active and important topic in recent medical research. Many methods have been proposed in the…”
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Clinically relevant QTc prolongation is not associated with current dose schedules of LBH589 (panobinostat)
Published in Journal of clinical oncology (10-01-2008)Get full text
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A Bayesian Case Study in Oncology Phase I Combination Dose-Finding Using Logistic Regression with Covariates
Published in Journal of biopharmaceutical statistics (01-05-2009)“…A Bayesian approach to finding the maximum tolerated dose (MTD) is presented. The approach is flexible, allowing inclusion of covariates, and enables…”
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A randomized, double-blinded, phase II study of paclitaxel/carboplatin (PC) plus CT-322 versus PC plus bevacizumab (Bev) as first-line treatment for advanced nonsquamous non-small cell lung cancer (NSCLC)
Published in Journal of clinical oncology (20-05-2012)“…Abstract only 7584 Background: CT- 322 is a pegylated protein engineered from the tenth type III human fibronectin domain thatspecifically blocks VEGFR-2…”
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Phase IA/II Study of Oral Panobinostat (LBH589), a Novel Pan- Deacetylase Inhibitor (DACi) Demonstrating Efficacy in Patients with Advanced Hematologic Malignancies
Published in Blood (16-11-2008)“…Panobinostat (LBH589) is a novel and potent pan-deacetylase inhibitor (DACi) with broad preclinical activity in models of hematologic malignancies. This trial…”
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Phase II Trial of Oral Panobinostat (LBH589) in Patients with Refractory Cutaneous T-Cell Lymphoma (CTCL)
Published in Blood (16-11-2008)“…Background: Panobinostat is a histone deacetylase inhibitor that has shown promising results in cutaneous T-cell lymphoma (CTCL). Objectives: An open-label,…”
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Psychiatric Comorbidity and Not Completing Jail-based Substance Abuse Treatment
Published in The American journal on addictions (01-01-2004)“…Many jail inmates have a history of mental illness, substance use, and drug-related crime. This article assesses the effect of psychiatric comorbidity on…”
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Phase IA/II Study of Oral LBH589, a Novel Deacetylase Inhibitor (DACi), Administered on 2 Schedules, in Patients with Advanced Hematologic Malignancies
Published in Blood (16-11-2007)“…LBH589 is a novel cinnamic acid hydroxamate DACi which induces apoptosis in multiple hematologic tumor cell lines in vitro at nanomolar levels. LBH589 has been…”
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A Phase I/II Study of Intravenous LBH589, a Novel Histone Deacetylase (HDAC) Inhibitor, in Patients (pts) with Advanced Hematologic Malignancies
Published in Blood (16-11-2004)“…LBH589 is a novel HDAC inhibitor which activates p21 and inhibits proliferation and induces apoptosis in tumor cell lines at nanomolar concentrations. In this…”
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Jail-Based Substance User Treatment: An Analysis of Retention
Published in Substance use & misuse (01-01-2003)“…Many jail inmates have a history of substance use and "abuse"; few, however, receive comprehensive treatment for substance use disorders while in jail. The…”
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Nonparametric inference for the proportionality function in the random censorship model
Published in Journal of nonparametric statistics (01-04-2003)“…By generalizing the proportional hazards model, we introduce a new function β( t ), which we call the proportionality function, and which we show plays a role…”
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