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Mycophenolate Mofetil Versus Cyclophosphamide for Remission Induction in Childhood Polyarteritis Nodosa: An Open‐Label, Randomized, Bayesian Noninferiority Trial

Arthritis & rheumatology (Hoboken, N.J.), 2021-09, Vol.73 (9), p.1673-1682

2021

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Extrapolation of efficacy and other data to support the development of new medicines for children: A systematic review of methods

Statistical methods in medical research, 2018-02, Vol.27 (2), p.398-413

2018

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A robust Bayesian meta-analytic approach to incorporate animal data into phase I oncology trials

Statistical methods in medical research, 2020-01, Vol.29 (1), p.94-110

2020

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Group sequential tests for delayed responses (with discussion)

Journal of the Royal Statistical Society. Series B, Statistical methodology, 2013-01, Vol.75 (1), p.3-54

2013

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Bridging across patient subgroups in phase I oncology trials that incorporate animal data

Statistical methods in medical research, 2021-04, Vol.30 (4), p.1057-1071

2021

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Bayesian methods for the design and interpretation of clinical trials in very rare diseases

Statistics in medicine, 2014-10, Vol.33 (24), p.4186-4201

2014

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Many-to-one comparisons after safety selection in multi-arm clinical trials

PloS one, 2017-06, Vol.12 (6), p.e0180131-e0180131

2017

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A Bayesian decision‐theoretic approach to incorporate preclinical information into phase I oncology trials

Biometrical journal, 2020-10, Vol.62 (6), p.1408-1427

2020

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Assurance methods for designing a clinical trial with a delayed treatment effect

Statistics in medicine, 2024-08, Vol.43 (19), p.3595-3612

2024

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DELTA 2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial

BMJ (Online), 2018-11, Vol.363, p.k3750

2018

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Handbook of Statistical Methods for Randomized Controlled Trials

1, 2021

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A phase I trial of the γ-secretase inhibitor MK-0752 in combination with gemcitabine in patients with pancreatic ductal adenocarcinoma

British journal of cancer, 2018-03, Vol.118 (6), p.793-801

2018

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Exposure–response modelling approaches for determining optimal dosing rules in children

Statistical methods in medical research, 2020-09, Vol.29 (9), p.2583-2602

2020

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A New Comprehensive Approach to Assess the Probability of Success of Development Programs Before Pivotal Trials

Clinical pharmacology and therapeutics, 2022-05, Vol.111 (5), p.1050-1060

2022

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Eliciting judgements about dependent quantities of interest: The SHeffield ELicitation Framework extension and copula methods illustrated using an asthma case study

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2022-09, Vol.21 (5), p.1005-1021

2022

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Designing multi-arm multi-stage clinical trials using a risk-benefit criterion for treatment selection

Statistics in medicine, 2016-02, Vol.35 (4), p.522-533

2016

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Optimizing the data combination rule for seamless phase II/III clinical trials

Statistics in medicine, 2015-01, Vol.34 (1), p.39-58

2015

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Effectiveness of tisagenlecleucel versus real-world standard of care in relapsed/refractory follicular lymphoma

Journal of comparative effectiveness research, 2023-07, Vol.12 (7), p.e220173-e220173

2023

Volltextzugriff (PDF)

Elicitation of expert prior opinion: application to the MYPAN trial in childhood polyarteritis nodosa

PloS one, 2015-03, Vol.10 (3), p.e0120981

2015

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Improving the assessment of the probability of success in late stage drug development

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2022-03, Vol.21 (2), p.439-459

2022

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Comment on "Biostatistical Considerations When Using RWD and RWE in Clinical Studies for Regulatory Purposes: A Landscape Assessment"

Statistics in biopharmaceutical research, 2023-01, Vol.15 (1), p.23-26

2023

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Incorporating individual historical controls and aggregate treatment effect estimates into a Bayesian survival trial: a simulation study

BMC medical research methodology, 2019-04, Vol.19 (1), p.85-85, Article 85

2019

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Study to evaluate the optimal dose of remifentanil required to ensure apnea during magnetic resonance imaging of the heart under general anesthesia

Pediatric anesthesia, 2021-05, Vol.31 (5), p.548-556

2021

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Asymmetric inner wedge group sequential tests with applications to verifying whether effective drug concentrations are similar in adults and children

Statistics in medicine, 2017-02, Vol.36 (3), p.426-441

2017

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A framework for prospectively defining progression rules for internal pilot studies monitoring recruitment

Statistical methods in medical research, 2018-12, Vol.27 (12), p.3612-3627

2018

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Mycophenolate Mofetil Versus Cyclophosphamide for Remission Induction in Childhood Polyarteritis Nodosa: An Open‐Label, Randomized, Bayesian Noninferiority Trial

Extrapolation of efficacy and other data to support the development of new medicines for children: A systematic review of methods

A robust Bayesian meta-analytic approach to incorporate animal data into phase I oncology trials

Group sequential tests for delayed responses (with discussion)

Bridging across patient subgroups in phase I oncology trials that incorporate animal data

Bayesian methods for the design and interpretation of clinical trials in very rare diseases

Many-to-one comparisons after safety selection in multi-arm clinical trials

A Bayesian decision‐theoretic approach to incorporate preclinical information into phase I oncology trials

Assurance methods for designing a clinical trial with a delayed treatment effect

DELTA 2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial

Handbook of Statistical Methods for Randomized Controlled Trials

A phase I trial of the γ-secretase inhibitor MK-0752 in combination with gemcitabine in patients with pancreatic ductal adenocarcinoma

Exposure–response modelling approaches for determining optimal dosing rules in children

A New Comprehensive Approach to Assess the Probability of Success of Development Programs Before Pivotal Trials

Eliciting judgements about dependent quantities of interest: The SHeffield ELicitation Framework extension and copula methods illustrated using an asthma case study

Designing multi-arm multi-stage clinical trials using a risk-benefit criterion for treatment selection

Optimizing the data combination rule for seamless phase II/III clinical trials

Effectiveness of tisagenlecleucel versus real-world standard of care in relapsed/refractory follicular lymphoma

Elicitation of expert prior opinion: application to the MYPAN trial in childhood polyarteritis nodosa

Improving the assessment of the probability of success in late stage drug development

Comment on "Biostatistical Considerations When Using RWD and RWE in Clinical Studies for Regulatory Purposes: A Landscape Assessment"

Incorporating individual historical controls and aggregate treatment effect estimates into a Bayesian survival trial: a simulation study

Study to evaluate the optimal dose of remifentanil required to ensure apnea during magnetic resonance imaging of the heart under general anesthesia

Asymmetric inner wedge group sequential tests with applications to verifying whether effective drug concentrations are similar in adults and children

A framework for prospectively defining progression rules for internal pilot studies monitoring recruitment

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