Explanipedia

A computational method for type I error rate control in power-maximizing response-adaptive randomization Open

Stef Baas, Lukas Pin, Sofía S. Villar, William F. Rosenberger · 2025

Maximizing statistical power in experimental design often involves imbalanced treatment allocation, but several challenges hinder its practical adoption: (1) the misconception that equal allocation always maximizes power, (2) when only tar…

Revisiting optimal allocations for binary responses: insights from considering type-I error rate control Open

Lukas Pin, Sofía S. Villar, William F. Rosenberger · 2025

This work revisits optimal response-adaptive designs from a type-I error rate perspective, highlighting when and how much these allocations exacerbate type-I error rate inflation—an issue previously undocumented. We explore a range of appr…

Revisiting Optimal Allocations for Binary Responses: Insights from Considering Type-I Error Rate Control Open

Lukas Pin, Sofía S. Villar, William F. Rosenberger · 2025

This work revisits optimal response-adaptive designs from a type-I error rate perspective, highlighting when and how much these allocations exacerbate type-I error rate inflation - an issue previously undocumented. We explore a range of ap…

Exploring Stratification Strategies for Population‐ Versus Randomization‐Based Inference Open

Marco Novelli, William F. Rosenberger · 2024

Stratification on important variables is a common practice in clinical trials, since ensuring cosmetic balance on known baseline covariates is often deemed to be a crucial requirement for the credibility of the experimental results. Howeve…

Optimal design for inference on the threshold of a biomarker Open

Alessandro Baldi Antognini, Rosamarie Frieri, William F. Rosenberger, Maroussa Zagoraiou · 2024

Enrichment designs with a continuous biomarker require the estimation of a threshold to determine the subpopulation benefitting from the treatment. This article provides the optimal allocation for inference in a two-stage enrichment design…

A Two-Stage Covariate-Adjusted Response-Adaptive Enrichment Design Open

Li Yang, Guoqing Diao, William F. Rosenberger · 2024

In the precision medicine paradigm, it is of interest to identify subgroups that benefit most from the treatment. However, the subgroup often cannot be identified until after a large-scale clinical trial. Clinical trials are often designed…

Response-Adaptive Randomization Designs Based on Optimal Allocation Proportions Open

Lukas Pin, Sofía S. Villar, William F. Rosenberger · 2024

This book chapter discusses response-adaptive randomization procedures which are based on optimal allocation proportions, e.g. derived from theoretical optimization problems. We elucidate the objectives of these proportions, emphasizing th…

Randomization-Based Inference for Clinical Trials with Missing Outcome Data Open

N Heussen, R.-D Hilgers, William F. Rosenberger, Xiao Tan, Diane Uschner · 2023

Randomization-based inference is a natural way to analyze data from a clinical trial. But the presence of missing outcome data is problematic: if the data are removed, the randomization distribution is destroyed and randomization tests hav…

Design Considerations for Two-Stage Enrichment Clinical Trials Open

Rosamarie Frieri, William F. Rosenberger, Nancy Flournoy, Zhantao Lin · 2022

When there is a predictive biomarker, enrichment can focus the clinical trial on a benefiting subpopulation. We describe a two-stage enrichment design, in which the first stage is designed to efficiently estimate a threshold and the second…

The Temptation of Overgeneralizing Response-adaptive Randomization Open

Sofía S. Villar, David S. Robertson, William F. Rosenberger · 2020

Dear Editor – We read with interest the recent article by Proschan and Evans [1] on the use of response-adaptive randomization (RAR) and its potential problems; however, these problems are neither new nor applicable in general to all RAR p…

Random Norming Aids Analysis of Non-linear Regression Models with Sequential Informative Dose Selection Open

Zhantao Lin, Nancy Flournoy, William F. Rosenberger · 2019

A two-stage adaptive optimal design is an attractive option for increasing the efficiency of clinical trials. In these designs, based on interim data, the locally optimal dose is chosen for further exploration, which induces dependencies b…

Design and analysis of stratified clinical trials in the presence of bias Open

R.-D Hilgers, Martin Manolov, N Heussen, William F. Rosenberger · 2019

Background Among various design aspects, the choice of randomization procedure have to be agreed on, when planning a clinical trial stratified by center. The aim of the paper is to present a methodological approach to evaluate whether a ra…

Sociodemographic disparities in corticolimbic structures Open

Danielle Shaked, Zachary B. Millman, Danielle L. Beatty Moody, William F. Rosenberger, Hui Shao , et al. · 2019

This study sought to examine the interactive relations of socioeconomic status and race to corticolimbic regions that may play a key role in translating stress to the poor health outcomes overrepresented among those of lower socioeconomic …

Lifetime discrimination burden, racial discrimination, and subclinical cerebrovascular disease among African Americans. Open

Danielle L. Beatty Moody, Antione D Taylor, Daniel K. Leibel, Elias Al-Najjar, Leslie I. Katzel , et al. · 2018

Explore interactive relations of lifetime discrimination burden and racial discrimination – chronic stressors among African Americans (AA) – and age with magnetic resonance imaging (MRI)-assessed white matter lesion volume (WMLV), a progno…

Nonparametric covariate-adjusted response-adaptive design based on a functional urn model Open

Giacomo Aletti, Andrea Ghiglietti, William F. Rosenberger · 2018

In this paper we propose a general class of covariate-adjusted\nresponse-adaptive (CARA) designs based on a new functional urn model. We prove\nstrong consistency concerning the functional urn proportion and the proportion\nof subjects ass…

ERDO - a framework to select an appropriate randomization procedure for clinical trials Open

R.-D Hilgers, Diane Uschner, William F. Rosenberger, N Heussen · 2017

The proposed ERDO framework guides the investigator through a template for the choice of a randomization procedure, and provides easy to use tools for the assessment. The barriers for the thorough reporting and assessment of randomization …

Central limit theorem for an adaptive randomly reinforced urn model Open

Andrea Ghiglietti, Anand N. Vidyashankar, William F. Rosenberger · 2017

The generalized Pòlya urn (GPU) models and their variants have been investigated in several disciplines. However, typical assumptions made with respect to the GPU do not include urn models with diagonal replacement matrix, which arise in s…

Covariate-adjusted Response-adaptive Randomization for Multi-arm Clinical Trials Using a Modified Forward Looking Gittins Index Rule Open

Sofía S. Villar, William F. Rosenberger · 2017

Summary We introduce a non-myopic, covariate-adjusted response adaptive (CARA) allocation design for multi-armed clinical trials. The allocation scheme is a computationally tractable procedure based on the Gittins index solution to the cla…

Differential Associations of Socioeconomic Status With Global Brain Volumes and White Matter Lesions in African American and White Adults: the HANDLS SCAN Study Open

Shari R. Waldstein, Gregory A. Dore, Christos Davatzikos, Leslie I. Katzel, Rao P. Gullapalli , et al. · 2016

Objective The aim of the study was to examine interactive relations of race and socioeconomic status (SES) to magnetic resonance imaging (MRI)–assessed global brain outcomes with previously demonstrated prognostic significance for stroke, …

Beneficial Effects of Dry Needling for Treatment of Chronic Myofascial Pain Persist for 6 Weeks After Treatment Completion Open

Lynn H. Gerber, Siddhartha Sikdar, Jacqueline V. Aredo, Katee Armstrong, William F. Rosenberger , et al. · 2016

Background Dry needling is an effective treatment for reducing pain associated with active myofascial trigger points (a‐MTrPs) in the short term. The duration of the benefits of this treatment have not been fully assessed. Objective To det…

Nonlinear associations between plasma cholesterol levels and neuropsychological function. Open

Carrington R. Wendell, Alan B. Zonderman, Leslie I. Katzel, William F. Rosenberger, Victoria V Plamadeala , et al. · 2016

Results indicate differential associations between cholesterol and neuropsychological function across different ages and domains of function. High and low total and LDL cholesterol may confer both risk and benefit for suboptimal cognitive …

Front Matter Open

William F. Rosenberger, John M. Lachin · 2015

The prelims comprise: Half-Title Page Series Page Title Page Copyright Page Table of Contents Preface

Subject Index Open

William F. Rosenberger, John M. Lachin · 2015

Novel Use of Ultrasound Elastography to Quantify Muscle Tissue Changes After Dry Needling of Myofascial Trigger Points in Patients With Chronic Myofascial Pain Open

Diego Turo, Paul Otto, Md Murad Hossain, Tadesse Gebreab, Katherine Armstrong , et al. · 2015

Objectives To compare a mechanical heterogeneity index derived from ultrasound vibration elastography with physical findings before and after dry‐needling treatment of spontaneously painful active myofascial trigger points in the upper tra…

Dry Needling Alters Trigger Points in the Upper Trapezius Muscle and Reduces Pain in Subjects With Chronic Myofascial Pain Open

Lynn H. Gerber, Jay Shah, William F. Rosenberger, Kathryn Armstrong, Diego Turo , et al. · 2015

Objective To determine whether dry needling of an active myofascial trigger point (MTrP) reduces pain and alters the status of the trigger point to either a non–spontaneously tender nodule or its resolution. Design A prospective, nonrandom…

A Conversation with Nancy Flournoy Open

William F. Rosenberger · 2015

Nancy Flournoy was born in Long Beach, California, on May 4, 1947. After\ngraduating from Polytechnic School in Pasadena in 1965, she earned a B.S.\n(1969) and M.S. (1971) in biostatistics from UCLA. Between her bachelors and\nmasters degr…

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