Search Results - "Ruberg, Stephen"

Reply to 'Bayesian approaches in drug development: continuing the virtuous cycle' by Ruberg, Stephen J

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Détente: A Practical Understanding of P values and Bayesian Posterior Probabilities by Ruberg, Stephen J.

“…Null hypothesis significance testing (NHST) with its benchmark P value < 0.05 has long been a stalwart of scientific reporting and such statistically…”
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Application of Bayesian approaches in drug development: starting a virtuous cycle by Ruberg, Stephen J., Beckers, Francois, Hemmings, Rob, Honig, Peter, Irony, Telba, LaVange, Lisa, Lieberman, Grazyna, Mayne, James, Moscicki, Richard

“…The pharmaceutical industry and its global regulators have routinely used frequentist statistical methods, such as null hypothesis significance testing and p…”
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Estimands in clinical trials – broadening the perspective by Akacha, Mouna, Bretz, Frank, Ruberg, Stephen

“…Defining the scientific questions of interest in a clinical trial is crucial to align its planning, design, conduct, analysis, and interpretation. However,…”
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Subgroup identification from randomized clinical trial data by Foster, Jared C., Taylor, Jeremy M.G., Ruberg, Stephen J.

“…We consider the problem of identifying a subgroup of patients who may have an enhanced treatment effect in a randomized clinical trial, and it is desirable…”
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Assessing and communicating heterogeneity of treatment effects for patient subpopulations: The hardest problem there is by Ruberg, Stephen J.

“…Heterogeneity is an enormously complex problem because there are so many dimensions and variables that can be considered when assessing which ones may…”
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Considerations for Evaluating Treatment Effects From Randomized Clinical Trials by Ruberg, Stephen J., Akacha, Mouna

“…This article focuses on the choice of treatment effect measures in randomized clinical trials (RCTs). Traditionally, an intention‐to‐treat (ITT) analysis is…”
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Implementation of tripartite estimands using adherence causal estimators under the causal inference framework by Qu, Yongming, Luo, Junxiang, Ruberg, Stephen J.

“…Summary Intercurrent events (ICEs) and missing values are inevitable in clinical trials of any size and duration, making it difficult to assess the treatment…”
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Efficiency of Two Sample Tests via the Restricted Mean Survival Time for Analyzing Event Time Observations by Tian, Lu, Fu, Haoda, Ruberg, Stephen J., Uno, Hajime, Wei, Lee-Jen

“…In comparing two treatments with the event time observations, the hazard ratio (HR) estimate is routinely used to quantify the treatment difference. However,…”
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Estimating the treatment effect for adherers using multiple imputation by Luo, Junxiang, Ruberg, Stephen J., Qu, Yongming

“…Randomized controlled trials are considered the gold standard to evaluate the treatment effect (estimand) for efficacy and safety. According to the recent…”
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Inference and Decision Making for 21st-Century Drug Development and Approval by Ruberg, Stephen J., Harrell, Frank E., Gamalo-Siebers, Margaret, LaVange, Lisa, Jack Lee, J., Price, Karen, Peck, Carl

“…The cost and time of pharmaceutical drug development continue to grow at rates that many say are unsustainable. These trends have enormous impact on what…”
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Accurate Collection of Reasons for Treatment Discontinuation to Better Define Estimands in Clinical Trials by Qu, Yongming, White, Robin D, Ruberg, Stephen J

“…Reasons for treatment discontinuation are important not only to understand the benefit and risk profile of experimental treatments, but also to help choose…”
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Making what's advanced today routine tomorrow by Ruberg, Stephen J.

“…Statistical principles and ongoing proliferation of novel statistical methodologies have dramatically improved the clinical drug development process. This…”
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The mean does not mean as much anymore: finding sub-groups for tailored therapeutics by Ruberg, Stephen J, Lei Chen, Yanping Wang

“…Background The genomics revolution is still in its infancy, and there is much to learn about how to transform biological knowledge into useful medicines to…”
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Statistical refocusing in the design of Phase II trials offers promise of increased R&D productivity by Lindborg, Stacy R., Persinger, Charles C., Sashegyi, Andreas, Mallinckrodt, Craig, Ruberg, Stephen J.

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Identification of early changes in specific symptoms that predict longer-term response to atypical antipsychotics in the treatment of patients with schizophrenia by Ruberg, Stephen J, Chen, Lei, Stauffer, Virginia, Ascher-Svanum, Haya, Kollack-Walker, Sara, Conley, Robert R, Kane, John, Kinon, Bruce J

“…To identify a simple decision tree using early symptom change to predict response to atypical antipsychotic therapy in patients with (Diagnostic and…”
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Raising the bar of efficacy for drug approval requires an understanding of patient diversity by Berger, Marc L, Eck, Stephen, Ruberg, Stephen J

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Early improvement in pain predicts pain response at endpoint in patients with fibromyalgia by Wang, Fujun, Ruberg, Stephen J, Gaynor, Paula J, Heinloth, Alexandra N, Arnold, Lesley M

“…An unanswered, but clinically important question is whether there are early indicators that a patient might respond to duloxetine treatment for fibromyalgia…”
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Identifying Potential Adverse Events Dose-Response Relationships Via Bayesian Indirect and Mixed Treatment Comparison Models by Fu, Haoda, Price, Karen L., Nilsson, Mary E., Ruberg, Stephen J.

“…Patients and prescribers need to be fully informed regarding the safety profile of approved medications. This includes knowledge and information regarding…”
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Post Hoc Analysis: Early Changes in ADHD-RS Items Predict Longer Term Response to Atomoxetine in Pediatric Patients by Block, Stan L., Williams, David, Donnelly, Craig L., Dunn, David W., Saylor, Keith E., Ruberg, Stephen J.

“…Data from 5 atomoxetine trials in pediatric outpatients with attention-deficit/hyperactivity disorder (ADHD) were divided into training and validation data…”
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