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Embedding a COVID-19 group sequential clinical trial within an ongoing trial: lessons from an unusual experience

Pierre-François Dequin , Amélie Le Gouge , Elsa Tavernier , Bruno Giraudeau , Sarah Zohar
Statistics in Biopharmaceutical Research, 2020, 12 (4), pp.478-482. ⟨10.1080/19466315.2020.1800509⟩
Article dans une revue hal-03122980v1

Coping with Information Loss and the Use of Auxiliary Sources of Data: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions

Silvia Calderazzo , Sergey Tarima , Carissa Reid , Nancy Flournoy , Tim Friede , et al.
Statistics in Biopharmaceutical Research, 2023, pp.1-17. ⟨10.1080/19466315.2023.2211023⟩
Article dans une revue hal-04336804v1
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dfcomb: An R-package for phase I/II trials of drug combinations

Marie-Karelle Riviere , Jacques-Henri Jourdan , Sarah Zohar
Computer Methods and Programs in Biomedicine, 2016, 125, pp.117-133. ⟨10.1016/j.cmpb.2015.10.018⟩
Article dans une revue hal-01297367v1
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Dose-finding methods for Phase I clinical trials using pharmacokinetics in small populations

Moreno Ursino , Sarah Zohar , Frederike Lentz , Corinne Alberti , Tim Friede , et al.
Biometrical Journal, 2017, 59 (4), pp.804-825. ⟨10.1002/bimj.201600084⟩
Article dans une revue hal-01560222v1
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Designs of drug-combination phase I trials in oncology: a systematic review of the literature

Marie-Karelle Riviere , C. Le Tourneau , X. Paoletti , F. Dubois , Sarah Zohar
Annals of Oncology, 2015, 26 (4), pp.669-674. ⟨10.1093/annonc/mdu516⟩
Article dans une revue hal-01298650v1
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A dose finding design for seizure reduction in neonates

Moreno Ursino , Ying Yuan , Corinne Alberti , Emmanuelle Comets , Geraldine Favrais , et al.
Journal of the Royal Statistical Society: Series C Applied Statistics, 2019, 68 (2), pp.427-444. ⟨10.1111/rssc.12289⟩
Article dans une revue hal-03862983v1

Using the continual reassessment method to estimate the minimum effective dose in phase II dose-finding studies: a case study

Sarah Zohar , Matthieu Resche-Rigon , Sylvie Chevret
Clinical Trials, 2013, 10 (3), pp.414-421. ⟨10.1177/1740774511411593⟩
Article dans une revue inserm-02456741v1
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A straightforward meta‐analysis approach for oncology phase I dose‐finding studies

Christian Röver , Moreno Ursino , Tim Friede , Sarah Zohar
Statistics in Medicine, 2022, 41 (20), pp.3915-3940. ⟨10.1002/sim.9484⟩
Article dans une revue hal-03864767v1
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Systematic reviews in paediatric multiple sclerosis and Creutzfeldt-Jakob disease exemplify shortcomings in methods used to evaluate therapies in rare conditions

Steffen Unkel , Christian Röver , Nigel Stallard , Norbert Benda , Martin Posch , et al.
Orphanet Journal of Rare Diseases, 2016, 11, pp.16. ⟨10.1186/s13023-016-0402-6⟩
Article dans une revue hal-01286678v1
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Designing a paediatric study for an antimalarial drug including prior information from adults

Caroline Petit , Vincent Jullien , Adeline Samson , Jérémie Guedj , Jean-René Kiechel , et al.
Antimicrobial Agents and Chemotherapy, 2016, 60 (3), pp.1481-1491. ⟨10.1128/AAC.01125-15⟩
Article dans une revue hal-01255863v1
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Estimating Similarity of Dose–Response Relationships in Phase I Clinical Trials—Case Study in Bridging Data Package

Adrien Ollier , Sarah Zohar , Satoshi Morita , Moreno Ursino
International Journal of Environmental Research and Public Health, 2021, 18 (4), pp.1639. ⟨10.3390/ijerph18041639⟩
Article dans une revue hal-03878713v1

Application of the Continual Reassessment Method to Dose-finding Studies in Regional Anesthesia

Abhinav Kant , Pawan Kumar Gupta , Sarah Zohar , Sylvie Chevret , Philip Hopkins
Anesthesiology, 2013, 119 (1), pp.29-35. ⟨10.1097/ALN.0b013e31829764cf⟩
Article dans une revue inserm-02456728v1
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Bayesian variable selection based on clinical relevance weights in small sample studies—Application to colon cancer

Sandrine Boulet , Moreno Ursino , Peter F Thall , Anne-Sophie Jannot , Sarah Zohar
Statistics in Medicine, 2019, 38 (12), pp.2228-2247. ⟨10.1002/sim.8107⟩
Article dans une revue hal-02120840v1

Planning a Bayesian early-phase phase I/II study for human vaccines in HER2 carcinomas

Sarah Zohar , Ileana Baldi , Guido Forni , Franco Merletti , Giuseppe Masucci , et al.
Pharmaceutical Statistics, 2011, 10 (3), pp.218-226. ⟨10.1002/pst.450⟩
Article dans une revue istex inserm-02456773v1

Incorporating lower grade toxicity information into dose finding designs

Alexia Iasonos , Sarah Zohar , John O'Quigley
Clinical Trials, 2011, 8 (4), pp.370-379. ⟨10.1177/1740774511410732⟩
Article dans une revue inserm-02456758v1

Hematopoietic progenitor cell mobilization and harvesting in children with malignancies: do the advantages of pegfilgrastim really translate into clinical benefit?

Etienne Merlin , Sarah Zohar , C. Jérôme , Richard Veyrat-Masson , Geoffroy Marceau , et al.
Bone Marrow Transplantation, 2009, 43 (12), pp.919-25. ⟨10.1038/bmt.2008.412⟩
Article dans une revue inserm-00435572v1
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Bayesian design and conduct of phase II single-arm clinical trials with binary outcomes: A tutorial

Sarah Zohar , Satoshi Teramukai , Yinghui Zhou
Contemporary Clinical Trials Communications, 2008, 29 (4), pp.608-616. ⟨10.1016/j.cct.2007.11.005⟩
Article dans une revue inserm-02456790v1
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Recommendations for the design of therapeutic trials for neonatal seizures

Janet S Soul , Ronit Pressler , Marilee Allen , Geraldine Boylan , Heike Rabe , et al.
Pediatric Research, 2019, 85 (7), pp.943-954. ⟨10.1038/s41390-018-0242-2⟩
Article dans une revue hal-02149297v1

Phase I/II dose-finding design for molecularly targeted agent: Plateau determination using adaptive randomization

Marie-Karelle Riviere , Ying Yuan , Jacques-Henri Jourdan , Frédéric Dubois , Sarah Zohar
Statistical Methods in Medical Research, 2018, 27 (2), pp.466-479. ⟨10.1177/0962280216631763⟩
Article dans une revue hal-03864773v1

Exploring how non-inferiority and equivalence are assessed in paediatrics: a systematic review

Camille Aupiais , Sarah Zohar , Garry Taverny , Enora Le Roux , Rym Boulkedid , et al.
Archives of Disease in Childhood, 2018, pp.archdischild-2018-314874. ⟨10.1136/archdischild-2018-314874⟩
Article dans une revue hal-03864775v1

Approaches to sample size calculation for clinical trials in rare diseases

Tim Friede , Corinne Alberti , Norbert Benda , Emmanuelle Comets , Alex Dmitrienko , et al.
Pharmaceutical Statistics, 2018, 17 (3), pp.214-230. ⟨10.1002/pst.1848⟩
Article dans une revue inserm-02456642v1
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Response to comments on ‘Competing designs for drug combination in phase I dose-finding clinical trials’ by G. Yin, R. Lin and N. Wages

Marie-Karelle Riviere , Frédéric Dubois , Sarah Zohar
Statistics in Medicine, 2015, 34 (1), pp.23-26. ⟨10.1002/sim.6332⟩
Article dans une revue istex hal-01298661v1

Comments on ‘A comparative study of adaptive dose-finding designs for phase I oncology trials of combination therapies’

Marie-Karelle Riviere , Sarah Zohar
Statistics in Medicine, 2016, 35 (3), pp.475-478. ⟨10.1002/sim.6630⟩
Article dans une revue istex inserm-02456674v1

Clinical Trials Impacted by the COVID-19 Pandemic: Adaptive Designs to the Rescue?

Cornelia Ursula Kunz , Silke Jörgens , Frank Bretz , Nigel Stallard , Kelly van Lancker , et al.
Statistics in Biopharmaceutical Research, 2020, 12 (4), pp.461-477. ⟨10.1080/19466315.2020.1799857⟩
Article dans une revue hal-03122985v1

Dose-finding designs using a novel quasi-continuous endpoint for multiple toxicities

Monia Ezzalfani , Sarah Zohar , Rui Qin , Sumithra Mandrekar , Marie-Cécile Le Deley
Statistics in Medicine, 2013, 32 (16), pp.2728-2746. ⟨10.1002/sim.5737⟩
Article dans une revue inserm-02456722v1
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Bayesian dose‐regimen assessment in early phase oncology incorporating pharmacokinetics and pharmacodynamics

Emma Gerard , Sarah Zohar , Hoai‐thu Thai , Christelle Lorenzato , Marie‐karelle Riviere , et al.
Biometrics, 2022, ⟨10.1111/biom.13433⟩
Article dans une revue hal-03141298v1

Bayesian sample size determination for phase IIA clinical trials using historical data and semi‐parametric prior's elicitation

Paola Berchialla , Sarah Zohar , Ileana Baldi
Pharmaceutical Statistics, 2018, 18 (2), pp.198-211. ⟨10.1002/pst.1914⟩
Article dans une revue hal-03862856v1

Approaches to sample size calculation for clinical trials in rare diseases

Frank Miller , Sarah Zohar , Nigel Stallard , Jason Madan , Martin Posch , et al.
Pharmaceutical Statistics, 2018, 17 (3), pp.214-230. ⟨10.1002/pst.1848⟩
Article dans une revue hal-03864774v1

dfpk: An R-package for Bayesian dose-finding designs using pharmacokinetics (PK) for phase I clinical trials

A. Toumazi , E. Comets , C. Alberti , T. Friede , F. Lentz , et al.
Computer Methods and Programs in Biomedicine, 2018, 157, pp.163-177. ⟨10.1016/j.cmpb.2018.01.023⟩
Article dans une revue hal-03864772v1
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Decision-theoretic designs for small trials and pilot studies: A review

Siew Wan Hee , Thomas Hamborg , Simon Day , Jason Madan , Frank Miller , et al.
Statistical Methods in Medical Research, 2016, 25 (3), pp.1022-1038. ⟨10.1177/0962280215588245⟩
Article dans une revue inserm-02456662v1