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Application of Bayesian approaches in drug development: starting a virtuous cycle

Nature reviews. Drug discovery, 2023-03, Vol.22 (3), p.235-250

2023

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Subgroup identification from randomized clinical trial data

Statistics in medicine, 2011-10, Vol.30 (24), p.2867-2880

2011

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Efficiency of Two Sample Tests via the Restricted Mean Survival Time for Analyzing Event Time Observations

Biometrics, 2018-06, Vol.74 (2), p.694-702

2018

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Inference and Decision Making for 21st-Century Drug Development and Approval

The American statistician, 2019-03, Vol.73 (sup1), p.319-327

2019

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Détente: A Practical Understanding of P values and Bayesian Posterior Probabilities

Clinical pharmacology and therapeutics, 2021-06, Vol.109 (6), p.1489-1498

Ruberg, Stephen J.

2021

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Assessing and communicating heterogeneity of treatment effects for patient subpopulations: The hardest problem there is

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2021-09, Vol.20 (5), p.939-944

Ruberg, Stephen J.

2021

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Considerations for Evaluating Treatment Effects From Randomized Clinical Trials

Clinical pharmacology and therapeutics, 2017-12, Vol.102 (6), p.917-923

2017

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Implementation of tripartite estimands using adherence causal estimators under the causal inference framework

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2021-01, Vol.20 (1), p.55-67

2021

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Estimating the treatment effect for adherers using multiple imputation

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2022-05, Vol.21 (3), p.525-534

2022

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Accurate Collection of Reasons for Treatment Discontinuation to Better Define Estimands in Clinical Trials

Therapeutic innovation & regulatory science, 2023-05, Vol.57 (3), p.521-528

2023

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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

BMC psychiatry, 2011-02, Vol.11 (1), p.23-23, Article 23

2011

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Making what's advanced today routine tomorrow

Journal of biopharmaceutical statistics, 2016-01, Vol.26 (1), p.55-70

Ruberg, Stephen J.

2016

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The mean does not mean as much anymore: finding sub-groups for tailored therapeutics

Clinical trials (London, England), 2010-10, Vol.7 (5), p.574-583

2010

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Statistical refocusing in the design of Phase II trials offers promise of increased R&D productivity

Nature reviews. Drug discovery, 2014-08, Vol.13 (8), p.638-640

2014

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Raising the bar of efficacy for drug approval requires an understanding of patient diversity

Journal of clinical oncology, 2010-07, Vol.28 (20), p.e343-e344

2010

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Early Improvement in Pain Predicts Pain Response at Endpoint in Patients With Fibromyalgia

The journal of pain, 2011-10, Vol.12 (10), p.1088-1094

2011

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A Bayesian Posterior Probability Is the Real Replication Probability

Statistics in biopharmaceutical research, 2020-11, Vol.13 (1), p.49-54

Ruberg, Stephen J.

2020

Volltextzugriff (PDF)

Identifying Potential Adverse Events Dose-Response Relationships Via Bayesian Indirect and Mixed Treatment Comparison Models

Journal of biopharmaceutical statistics, 2013-01, Vol.23 (1), p.26-42

2013

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Assessing the Commonly Used Assumptions in Estimating the Principal Causal Effect in Clinical Trials

Statistics in biopharmaceutical research, 2023-10, Vol.ahead-of-print (ahead-of-print), p.1-18

2023

Volltextzugriff (PDF)

Personalized Medicine: Four Perspectives of Tailored Medicine

Statistics in biopharmaceutical research, 2015-07, Vol.7 (3), p.214-229

2015

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Post Hoc Analysis: Early Changes in ADHD-RS Items Predict Longer Term Response to Atomoxetine in Pediatric Patients

Clinical pediatrics, 2010-08, Vol.49 (8), p.768-776

2010

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Paradigm shifts in clinical trials enabled by information technology

Statistics in medicine, 2001-09, Vol.20 (17-18), p.2683-2696

2001

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A semi-Markov model for patient progression through clinical trials

European journal of operational research, 2007, Vol.176 (1), p.542-549

2007

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Statistical Inference on the Estimators of the Adherer Average Causal Effect

Statistics in biopharmaceutical research, 2022-08, Vol.14 (3), p.392-395

2022

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A General Framework for Treatment Effect Estimators Considering Patient Adherence

Statistics in biopharmaceutical research, 2020-01, Vol.12 (1), p.1-18

2020

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Application of Bayesian approaches in drug development: starting a virtuous cycle

Subgroup identification from randomized clinical trial data

Efficiency of Two Sample Tests via the Restricted Mean Survival Time for Analyzing Event Time Observations

Inference and Decision Making for 21st-Century Drug Development and Approval

Détente: A Practical Understanding of P values and Bayesian Posterior Probabilities

Assessing and communicating heterogeneity of treatment effects for patient subpopulations: The hardest problem there is

Considerations for Evaluating Treatment Effects From Randomized Clinical Trials

Implementation of tripartite estimands using adherence causal estimators under the causal inference framework

Estimating the treatment effect for adherers using multiple imputation

Accurate Collection of Reasons for Treatment Discontinuation to Better Define Estimands in Clinical Trials

Identification of early changes in specific symptoms that predict longer-term response to atypical antipsychotics in the treatment of patients with schizophrenia

Making what's advanced today routine tomorrow

The mean does not mean as much anymore: finding sub-groups for tailored therapeutics

Statistical refocusing in the design of Phase II trials offers promise of increased R&D productivity

Raising the bar of efficacy for drug approval requires an understanding of patient diversity

Early Improvement in Pain Predicts Pain Response at Endpoint in Patients With Fibromyalgia

A Bayesian Posterior Probability Is the Real Replication Probability

Identifying Potential Adverse Events Dose-Response Relationships Via Bayesian Indirect and Mixed Treatment Comparison Models

Assessing the Commonly Used Assumptions in Estimating the Principal Causal Effect in Clinical Trials

Personalized Medicine: Four Perspectives of Tailored Medicine

Post Hoc Analysis: Early Changes in ADHD-RS Items Predict Longer Term Response to Atomoxetine in Pediatric Patients

Paradigm shifts in clinical trials enabled by information technology

A semi-Markov model for patient progression through clinical trials

Statistical Inference on the Estimators of the Adherer Average Causal Effect

A General Framework for Treatment Effect Estimators Considering Patient Adherence

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