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Single‐Arm Clinical Trials as Pivotal Evidence for Cancer Drug Approval: A Retrospective Cohort Study of Centralized European Marketing Authorizations Between 2010 and 2019

Clinical pharmacology and therapeutics, 2020-09, Vol.108 (3), p.653-660

2020

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Commentary: On the levels of patient selection in registry-based randomized controlled trials

Trials, 2019-02, Vol.20 (1), p.100-100, Article 100

2019

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Estimands in CNS trials – A review of strategies for addressing intercurrent events

Contemporary clinical trials communications, 2024-04, Vol.38, p.101266-101266, Article 101266

2024

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Empirical evaluation of the implementation of the EMA guideline on missing data in confirmatory clinical trials: Specification of mixed models for longitudinal data in study protocols

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2019-11, Vol.18 (6), p.636-644

2019

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A plea to provide best evidence in trials under sample-size restrictions: the example of pioglitazone to resolve leukoplakia and erythroplakia in Fanconi anemia patients

Orphanet journal of rare diseases, 2017-05, Vol.12 (1), p.102-102, Article 102

2017

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Randomized placebo-controlled clinical trial investigating the effect of antioxidants and a vasodilator on overall safety and residual hearing preservation in cochlear implant patients

Trials, 2020-07, Vol.21 (1), p.643-643, Article 643

2020

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Estimators for handling COVID‐19‐related intercurrent events with a hypothetical strategy

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2022-11, Vol.21 (6), p.1258-1280

2022

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New research strategy with ambiguous implications: A comment on “Planning future studies based on the conditional power of a meta‐analysis”

Statistics in medicine, 2018-04, Vol.37 (8), p.1402-1404

2018

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The Impact of COVID‐19 on the Initiation of Clinical Trials in Europe and the United States

Clinical pharmacology and therapeutics, 2022-05, Vol.111 (5), p.1093-1102

2022

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Type-I-error rate inflation in mixed models for repeated measures caused by ambiguous or incomplete model specifications

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2023-11, Vol.22 (6), p.1046-1061

2023

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A Simulation Study on the Estimation of the Effect in the Hypothetical Scenario of No Use of Symptomatic Treatment in Trials for Disease-Modifying Agents for Alzheimer's Disease

Statistics in biopharmaceutical research, 2023-04, Vol.15 (2), p.386-399

2023

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Microbiota-associated Risk Factors for Clostridioides difficile Acquisition in Hospitalized Patients: A Prospective, Multicentric Study

Clinical infectious diseases, 2021-11, Vol.73 (9), p.e2625-e2634

2021

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Randomization versus Real-World Evidence

The New England journal of medicine, 2020-07, Vol.383 (4), p.e21-e21

2020

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Free-breathing Dynamic 19 F Gas MR Imaging for Mapping of Regional Lung Ventilation in Patients with COPD

Radiology, 2018-03, Vol.286 (3), p.1040

2018

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Potential impact of COVID‐19 on ongoing clinical trials: a simulation study with the neurological Yale Global Tic Severity Scale based on the CANNA‐TICS study

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2021-05, Vol.20 (3), p.675-691

2021

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Improving Maximal Strength in the Initial Postoperative Phase After Anterior Cruciate Ligament Reconstruction Surgery: Randomized Controlled Trial of an App-Based Serious Gaming Approach

JMIR serious games, 2020-01, Vol.8 (1), p.e14282-e14282

2020

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Simplified Measurement of Maximum Strength After Knee Surgery: Application-Based Knee-Training Device Compared to Isokinetic Testing

Open access journal of sports medicine, 2020-01, Vol.11 (1), p.43-49

2020

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Accuracy, realism and general applicability of European forest models

Global change biology, 2022-12, Vol.28 (23), p.6921-6943

2022

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Integrating sustainability into strategic supplier portfolio selection

Management decision, 2016-01, Vol.54 (1), p.194-221

2016

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Scaling up of hydrogen supply chains: The role of supply chain governance

Logistics research, 2023-02, Vol.16 (1), p.1-20

2023

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Insights on the costs of humanitarian logistics: A case study analysis

Logistics research, 2020, Vol.13 (1), p.1-17

2020

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A clinical decision support tool may help to optimise vedolizumab therapy in Crohn’s disease

Alimentary pharmacology & therapeutics, 2020-03, Vol.51 (5), p.553-564

2020

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Integrating three-dimensional sustainability in distribution centre selection: the process analysis method-based analytic network process

International journal of production research, 2015-01, Vol.53 (2), p.409-434

2015

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Single‐Arm Clinical Trials as Pivotal Evidence for Cancer Drug Approval: A Retrospective Cohort Study of Centralized European Marketing Authorizations Between 2010 and 2019

Commentary: On the levels of patient selection in registry-based randomized controlled trials

Estimands in CNS trials – A review of strategies for addressing intercurrent events

Empirical evaluation of the implementation of the EMA guideline on missing data in confirmatory clinical trials: Specification of mixed models for longitudinal data in study protocols

A plea to provide best evidence in trials under sample-size restrictions: the example of pioglitazone to resolve leukoplakia and erythroplakia in Fanconi anemia patients

Randomized placebo-controlled clinical trial investigating the effect of antioxidants and a vasodilator on overall safety and residual hearing preservation in cochlear implant patients

Estimators for handling COVID‐19‐related intercurrent events with a hypothetical strategy

New research strategy with ambiguous implications: A comment on “Planning future studies based on the conditional power of a meta‐analysis”

The Impact of COVID‐19 on the Initiation of Clinical Trials in Europe and the United States

Type-I-error rate inflation in mixed models for repeated measures caused by ambiguous or incomplete model specifications

A Simulation Study on the Estimation of the Effect in the Hypothetical Scenario of No Use of Symptomatic Treatment in Trials for Disease-Modifying Agents for Alzheimer's Disease

Microbiota-associated Risk Factors for Clostridioides difficile Acquisition in Hospitalized Patients: A Prospective, Multicentric Study

Randomization versus Real-World Evidence

Free-breathing Dynamic 19 F Gas MR Imaging for Mapping of Regional Lung Ventilation in Patients with COPD

Potential impact of COVID‐19 on ongoing clinical trials: a simulation study with the neurological Yale Global Tic Severity Scale based on the CANNA‐TICS study

Improving Maximal Strength in the Initial Postoperative Phase After Anterior Cruciate Ligament Reconstruction Surgery: Randomized Controlled Trial of an App-Based Serious Gaming Approach

Simplified Measurement of Maximum Strength After Knee Surgery: Application-Based Knee-Training Device Compared to Isokinetic Testing

Comparison of MRI and VQ-SPECT as a Screening Test for Patients With Suspected CTEPH: CHANGE-MRI Study Design and Rationale

Accuracy, realism and general applicability of European forest models

Tree mortality submodels drive simulated long‐term forest dynamics: assessing 15 models from the stand to global scale

Integrating sustainability into strategic supplier portfolio selection

Scaling up of hydrogen supply chains: The role of supply chain governance

Insights on the costs of humanitarian logistics: A case study analysis

A clinical decision support tool may help to optimise vedolizumab therapy in Crohn’s disease

Integrating three-dimensional sustainability in distribution centre selection: the process analysis method-based analytic network process

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