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A narrative review of estimands in drug development and regulatory evaluation: old wine in new barrels?

Trials, 2020-07, Vol.21 (1), p.671-671, Article 671

2020

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Goal attainment scaling as an outcome measure in rare disease trials: a conceptual proposal for validation

BMC medical research methodology, 2019-12, Vol.19 (1), p.227-227, Article 227

2019

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Cannabidiol (Epidyolex®) for severe behavioral manifestations in patients with tuberous sclerosis complex, mucopolysaccharidosis type III and fragile X syndrome: protocol for a series of randomized, placebo-controlled N-of-1 trials

BMC psychiatry, 2024-01, Vol.24 (1), p.23-23, Article 23

2024

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Methylphenidate for attention-deficit/hyperactivity disorder in patients with Smith–Magenis syndrome: protocol for a series of N-of-1 trials

Orphanet journal of rare diseases, 2021-09, Vol.16 (1), p.1-380, Article 380

2021

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The SNAP Trial: 2-Year Results of a Double-Blind Multicenter Randomized Controlled Trial of a Silicon Nitride Versus a PEEK Cage in Patients After Lumbar Fusion Surgery

Global spine journal, 2022-10, Vol.12 (8), p.1687-1695

2022

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Bayesian sample size re-estimation using power priors

Statistical methods in medical research, 2019-06, Vol.28 (6), p.1664-1675

2019

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The POWER-tool: Recommendations for involving patient representatives in choosing relevant outcome measures during rare disease clinical trial design

Health policy (Amsterdam), 2018-12, Vol.122 (12), p.1287-1294

2018

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Ethics in musculoskeletal regenerative medicine; guidance in choosing the appropriate comparator in clinical trials

Osteoarthritis and cartilage, 2019-01, Vol.27 (1), p.34-40

2019

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Quantitative Falsification of Instrumental Variables Assumption Using Balance Measures

Epidemiology (Cambridge, Mass.), 2014-09, Vol.25 (5), p.770-772

2014

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Statistical analysis of Goal Attainment Scaling endpoints in randomised trials

Statistical methods in medical research, 2019-06, Vol.28 (6), p.1893-1910

2019

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Direct comparison of predictive performance of PRECISE-DAPT versus PARIS versus CREDO-Kyoto: a subanalysis of the ReCre8 trial

Netherlands heart journal, 2021-04, Vol.29 (4), p.201-214

2021

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Interpretation and Inference in Noninferiority Randomized Controlled Trials in Drug Research

Clinical pharmacology and therapeutics, 2010-09, Vol.88 (3), p.420-423

2010

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P812: Usefulness of movement and heart rate as physiological signals to detect nocturnal epileptic seizures

Clinical neurophysiology, 2014-06, Vol.125, p.S259-S260

2014

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Validation and Predictive Performance Assessment of Clinical Trial Simulation Models

Clinical pharmacology and therapeutics, 2011-04, Vol.89 (4), p.487-488

2011

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MEDUCATE trial: effectiveness of an intensive EDUCATional intervention for IT-mediated MEDication management in the outpatient clinic - study protocol for a cluster randomized controlled trial

Trials, 2015-05, Vol.16 (1), p.223-223, Article 223

2015

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A compilation of research working groups on drug utilisation across Europe

BMC research notes, 2014-03, Vol.7 (1), p.143-143, Article 143

2014

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Multimodal seizure detection: A review

Epilepsia (Copenhagen), 2018-06, Vol.59 (S1), p.42-47

2018

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New Perspectives on Technology in Society: Experimentation beyond the Laboratory

1st edition., 2018

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Pharmacological treatment of severely depressed patients: a meta-analysis comparing efficacy of mirtazapine and amitriptyline

European neuropsychopharmacology, 1997-05, Vol.7 (2), p.115-124

1997

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The Authors Reply

American journal of epidemiology, 2012-08, Vol.176 (4), p.358-359

2012

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The IMI PROTECT project: purpose, organizational structure, and procedures

Pharmacoepidemiology and drug safety, 2016-03, Vol.25 (S1), p.5-10

2016

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Inpatient Drug Utilization in Europe: Nationwide Data Sources and a Review of Publications on a Selected Group of Medicines (PROTECT Project)

Basic & clinical pharmacology & toxicology, 2015-03, Vol.116 (3), p.201-211

2015

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DESIGN AND ANALYSIS ISSUES FOR CROSSOVER DESIGNS IN PHASE I CLINICAL STUDIES

Journal of biopharmaceutical statistics, 1999-03, Vol.9 (1), p.109-128

1999

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Explaining the variation in the management of lifestyle risk factors in primary health care: a multilevel cross sectional study

BMC public health, 2009-05, Vol.9 (1), p.165-165, Article 165

2009

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Mirtazapine effects on alertness and sleep in patients as recorded by interactive telecommunication during treatment with different dosing regimens

Journal of clinical psychopharmacology, 2000-10, Vol.20 (5), p.531-537

2000

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A narrative review of estimands in drug development and regulatory evaluation: old wine in new barrels?

Goal attainment scaling as an outcome measure in rare disease trials: a conceptual proposal for validation

Cannabidiol (Epidyolex®) for severe behavioral manifestations in patients with tuberous sclerosis complex, mucopolysaccharidosis type III and fragile X syndrome: protocol for a series of randomized, placebo-controlled N-of-1 trials

Methylphenidate for attention-deficit/hyperactivity disorder in patients with Smith–Magenis syndrome: protocol for a series of N-of-1 trials

The SNAP Trial: 2-Year Results of a Double-Blind Multicenter Randomized Controlled Trial of a Silicon Nitride Versus a PEEK Cage in Patients After Lumbar Fusion Surgery

Bayesian sample size re-estimation using power priors

The POWER-tool: Recommendations for involving patient representatives in choosing relevant outcome measures during rare disease clinical trial design

Ethics in musculoskeletal regenerative medicine; guidance in choosing the appropriate comparator in clinical trials

Quantitative Falsification of Instrumental Variables Assumption Using Balance Measures

Statistical analysis of Goal Attainment Scaling endpoints in randomised trials

Direct comparison of predictive performance of PRECISE-DAPT versus PARIS versus CREDO-Kyoto: a subanalysis of the ReCre8 trial

Interpretation and Inference in Noninferiority Randomized Controlled Trials in Drug Research

P812: Usefulness of movement and heart rate as physiological signals to detect nocturnal epileptic seizures

Validation and Predictive Performance Assessment of Clinical Trial Simulation Models

MEDUCATE trial: effectiveness of an intensive EDUCATional intervention for IT-mediated MEDication management in the outpatient clinic - study protocol for a cluster randomized controlled trial

A compilation of research working groups on drug utilisation across Europe

Multimodal seizure detection: A review

New Perspectives on Technology in Society: Experimentation beyond the Laboratory

Pharmacological treatment of severely depressed patients: a meta-analysis comparing efficacy of mirtazapine and amitriptyline

The Authors Reply

The IMI PROTECT project: purpose, organizational structure, and procedures

Inpatient Drug Utilization in Europe: Nationwide Data Sources and a Review of Publications on a Selected Group of Medicines (PROTECT Project)

DESIGN AND ANALYSIS ISSUES FOR CROSSOVER DESIGNS IN PHASE I CLINICAL STUDIES

Explaining the variation in the management of lifestyle risk factors in primary health care: a multilevel cross sectional study

Mirtazapine effects on alertness and sleep in patients as recorded by interactive telecommunication during treatment with different dosing regimens

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