Moreno Ursino

2024

Journal articles

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Sandrine Boulet, Moreno Ursino, Robin Michelet, Linda Bs Aulin, Charlotte Kloft, et al.. Bayesian framework for multi-source data integration-Application to human extrapolation from preclinical studies. Statistical Methods in Medical Research, 2024, Statistical Methods in Medical Research, ⟨10.1177/09622802241231493⟩. ⟨hal-04513000⟩

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2023

Journal articles

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Christina Yap, Jan Rekowski, Moreno Ursino, Olga Solovyeva, Dhrusti Patel, et al.. Enhancing quality and impact of early phase dose-finding clinical trial protocols: SPIRIT Dose-finding Extension (SPIRIT-DEFINE) guidance. BMJ – British Medical Journal, In press, pp.e076386. ⟨10.1136/bmj-2023-076386⟩. ⟨hal-04336820⟩

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Christina Yap, Olga Solovyeva, Johann de Bono, Jan Rekowski, Dhrusti Patel, et al.. Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance. BMJ – British Medical Journal, In press, pp.e076387. ⟨10.1136/bmj-2023-076387⟩. ⟨hal-04336824⟩

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Didier Sciard, Kailai Xu, Anne Soulier, Guillaume Dufour, Moreno Ursino, et al.. Postoperative analgesia after surgical repair of distal radius fracture: a randomized comparison between distal peripheral nerve blockade and surgical site infiltration. Minerva Anestesiologica, 2023, 89 (10), ⟨10.23736/s0375-9393.23.16956-2⟩. ⟨hal-04336790⟩

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Olga Solovyeva, Munyaradzi Dimairo, Christopher Weir, Siew Wan Hee, Aude Espinasse, et al.. Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study. BMC Medicine, 2023, 21 (1), pp.246. ⟨10.1186/s12916-023-02937-0⟩. ⟨hal-04336816⟩

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Silvia Calderazzo, Sergey Tarima, Carissa Reid, Nancy Flournoy, Tim Friede, et al.. 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. Statistics in Biopharmaceutical Research, 2023, pp.1-17. ⟨10.1080/19466315.2023.2211023⟩. ⟨hal-04336804⟩

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Benjamin Duputel, Nigel Stallard, François Montestruc, Sarah Zohar, Moreno Ursino. Using dichotomized survival data to construct a prior distribution for a Bayesian seamless Phase II/III clinical trial. Statistical Methods in Medical Research, 2023, 32 (5), pp.963-977. ⟨10.1177/09622802231160554⟩. ⟨hal-04126394⟩

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Maëva Cotinat, Isabelle Boquet, Moreno Ursino, Cécile Brocard, Elisabeth Jouve, et al.. Riluzole for treating spasticity in patients with chronic traumatic spinal cord injury: Study protocol in the phase ib/iib adaptive multicenter randomized controlled RILUSCI trial. PLoS ONE, 2023, 18, ⟨10.1371/journal.pone.0276892⟩. ⟨hal-04087364⟩

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Conference papers

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Laura Caquelin, P. Badra, Moreno Ursino, Bruno Laviolle, Clara Locher. Meta-analysis of phase I dose-finding studies: Application for protein kinase inhibitors developed in oncology. EPICLIN 2023 17e Conférence francophone d’Épidémiologie Clinique – 30e Journées des statisticiens des Centres de Lutte contre le Cancer, May 2023, Villers-lès-Nancy, France. ⟨10.1016/j.respe.2023.101816⟩. ⟨hal-04266628⟩

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2022

Journal articles

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Christian Röver, Moreno Ursino, Tim Friede, Sarah Zohar. A straightforward meta‐analysis approach for oncology phase I dose‐finding studies. Statistics in Medicine, 2022, 41 (20), pp.3915-3940. ⟨10.1002/sim.9484⟩. ⟨hal-03864767⟩

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Thomas Schmitz, Muriel Doret-Dion, Loic Sentilhes, Olivier Parant, Olivier Claris, et al.. Neonatal outcomes for women at risk of preterm delivery given half dose versus full dose of antenatal betamethasone: a randomised, multicentre, double-blind, placebo-controlled, non-inferiority trial. The Lancet, 2022, 400 (10352), pp.592-604. ⟨10.1016/S0140-6736(22)01535-5⟩. ⟨hal-03872891⟩

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Emma Gerard, Sarah Zohar, Hoai‐thu Thai, Christelle Lorenzato, Marie‐karelle Riviere, et al.. Bayesian dose‐regimen assessment in early phase oncology incorporating pharmacokinetics and pharmacodynamics. Biometrics, 2022, ⟨10.1111/biom.13433⟩. ⟨hal-03141298⟩

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Moreno Ursino, Lucie Biard, Sylvie Chevret. DICE: A Bayesian model for early dose finding in phase I trials with multiple treatment courses. Biometrical Journal, In press, ⟨10.1002/bimj.202000369⟩. ⟨hal-03873768⟩

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2021

Journal articles

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Emma Gerard, Sarah Zohar, Christelle Lorenzato, Moreno Ursino, Marie‐karelle Riviere. Bayesian modeling of a bivariate toxicity outcome for early phase oncology trials evaluating dose regimens. Statistics in Medicine, 2021, ⟨10.1002/sim.9113⟩. ⟨hal-03335297⟩

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Claire Dupuis, Etienne de Montmollin, Niccolò Buetti, Dany Goldgran-Toledano, Jean Reignier, et al.. Impact of early corticosteroids on 60-day mortality in critically ill patients with COVID-19: A multicenter cohort study of the OUTCOMEREA network. PLoS ONE, 2021, 16 (8), pp.e0255644. ⟨10.1371/journal.pone.0255644⟩. ⟨hal-03873780⟩

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Emma Gerard, Sarah Zohar, Christelle Lorenzato, Moreno Ursino, Marie‐karelle Riviere. Bayesian modeling of a bivariate toxicity outcome for early phase oncology trials evaluating dose regimens. Statistics in Medicine, 2021, ⟨10.1002/sim.9113⟩. ⟨hal-03288022⟩

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Emmanuelle Comets, Christelle Rodrigues, Vincent Jullien, Moreno Ursino. Conditional Non-parametric Bootstrap for Non-linear Mixed Effect Models. Pharmaceutical Research, 2021, 38 (6), pp.1057-1066. ⟨10.1007/s11095-021-03052-6⟩. ⟨hal-03280469⟩

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Robin Michelet, Moreno Ursino, Sandrine Boulet, Sebastian Franck, Fiordiligie Casilag, et al.. The Use of Translational Modelling and Simulation to Develop Immunomodulatory Therapy as an Adjunct to Antibiotic Treatment in the Context of Pneumonia. Pharmaceutics, 2021, 13 (5), pp.601. ⟨10.3390/pharmaceutics13050601⟩. ⟨hal-03215662⟩

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Adrien Coulet, Stéphanie Allassonniere, François Angoulvant, Anita Burgun, Xiaoyi Chen, et al.. L’équipe-projet HeKA. Bulletin de l’Association Française pour l’Intelligence Artificielle, 2021, 112, pp.29-32. ⟨hal-03485904⟩

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Moreno Ursino, Christian Röver, Sarah Zohar, Tim Friede. Random-effects meta-analysis of Phase I dose-finding studies using stochastic process priors. Annals of Applied Statistics, 2021, 15 (1), ⟨10.1214/20-AOAS1390⟩. ⟨hal-03206436⟩

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Adrien Ollier, Sarah Zohar, Satoshi Morita, Moreno Ursino. Estimating Similarity of Dose–Response Relationships in Phase I Clinical Trials—Case Study in Bridging Data Package. International Journal of Environmental Research and Public Health, 2021, 18 (4), pp.1639. ⟨10.3390/ijerph18041639⟩. ⟨hal-03878713⟩

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Moreno Ursino, Nigel Stallard. Bayesian Approaches for Confirmatory Trials in Rare Diseases: Opportunities and Challenges. International Journal of Environmental Research and Public Health, 2021, 18 (3), pp.1022. ⟨10.3390/ijerph18031022⟩. ⟨hal-03124245⟩

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Moreno Ursino, Claire Dupuis, Niccolò Buetti, Etienne de Montmollin, Lila Bouadma, et al.. Multistate Modeling of COVID-19 Patients Using a Large Multicentric Prospective Cohort of Critically Ill Patients. Journal of Clinical Medicine, 2021, 10 (3), pp.544. ⟨10.3390/jcm10030544⟩. ⟨hal-03134612⟩

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Claire Dupuis, Lila Bouadma, Etienne de Montmollin, Dany Goldgran-Toledano, Carole Schwebel, et al.. Association Between Early Invasive Mechanical Ventilation and Day-60 Mortality in Acute Hypoxemic Respiratory Failure Related to Coronavirus Disease-2019 Pneumonia. Critical Care Explorations, 2021, 3 (1), pp.e0329. ⟨10.1097/CCE.0000000000000329⟩. ⟨hal-03873783⟩

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2020

Journal articles

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Adrien Ollier, Satoshi Morita, Moreno Ursino, Sarah Zohar. An adaptive power prior for sequential clinical trials – Application to bridging studies. Statistical Methods in Medical Research, 2020, 29 (8), pp.2282-2294. ⟨10.1177/0962280219886609⟩. ⟨hal-03863036⟩

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Adrien Ollier, Satoshi Morita, Moreno Ursino, Sarah Zohar. An adaptive power prior for sequential clinical trials – Application to bridging studies. Statistical Methods in Medical Research, 2020, 29 (8), pp.2282-2294. ⟨10.1177/0962280219886609⟩. ⟨hal-03878712⟩

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Edda Battaglia, Valentina Boano, Moreno Ursino, Chiara Elia, Luigi Russo, et al.. Nissen fundoplication and dyspeptic symptoms: is the water load test useful?. Minerva Gastroenterologica e Dietologica, 2020, 66 (1), ⟨10.23736/S1121-421X.19.02632-1⟩. ⟨hal-03873786⟩

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Sandrine Boulet, Moreno Ursino, Peter F Thall, Bruno Landi, Céline Lepere, et al.. Integration of elicited expert information via a power prior in Bayesian variable selection: Application to colon cancer data. Statistical Methods in Medical Research, 2020, 38 (12), Ahead of print. ⟨10.1177/0962280219841082⟩. ⟨inserm-02456624⟩

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2019

Journal articles

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Camille Aupiais, Corinne Alberti, Thomas Schmitz, Olivier Baud, Moreno Ursino, et al.. A Bayesian non-inferiority approach using experts’ margin elicitation – application to the monitoring of safety events. BMC Medical Research Methodology, 2019, 19 (1), pp.187. ⟨10.1186/s12874-019-0826-5⟩. ⟨inserm-02456619⟩

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Adrien Ollier, Satoshi Morita, Moreno Ursino, Sarah Zohar. An adaptive power prior for sequential clinical trials – Application to bridging studies. Statistical Methods in Medical Research, 2019, pp.096228021988660. ⟨10.1177/0962280219886609⟩. ⟨inserm-02456616⟩

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Elvira Erhardt, Moreno Ursino, Jeike Biewenga, Tom Jacobs, Mauro Gasparini. Bayesian knowledge integration for an in vitro–in vivo correlation model. Biometrical Journal, 2019, 61 (5), pp.1104-1119. ⟨10.1002/bimj.201700263⟩. ⟨hal-03873774⟩

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Fabiola La Gamba, Tom Jacobs, Helena Geys, Thomas Jaki, Jan Serroyen, et al.. Bayesian sequential integration within a preclinical pharmacokinetic and pharmacodynamic modeling framework: Lessons learned. Pharmaceutical Statistics, 2019, pst.1941. ⟨10.1002/pst.1941⟩. ⟨hal-03873772⟩

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Moreno Ursino, Ying Yuan, Corinne Alberti, Emmanuelle Comets, Geraldine Favrais, et al.. A dose finding design for seizure reduction in neonates. Journal of the Royal Statistical Society: Series C Applied Statistics, 2019, 68 (2), pp.427-444. ⟨10.1111/rssc.12289⟩. ⟨hal-03862983⟩

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Peter Thall, Moreno Ursino, Véronique Baudouin, Corinne Alberti, Sarah Zohar. Bayesian treatment comparison using parametric mixture priors computed from elicited histograms. Statistical Methods in Medical Research, 2019, 28 (2), pp.404-418. ⟨10.1177/0962280217726803⟩. ⟨hal-03862933⟩

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Shing Lee, Moreno Ursino, Ying Kuen Cheung, Sarah Zohar. Dose-finding designs for cumulative toxicities using multiple constraints. Biostatistics, 2019, 20 (1), pp.17-29. ⟨10.1093/biostatistics/kxx059⟩. ⟨inserm-02456629⟩

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Géraldine Favrais, Moreno Ursino, Catherine Mouchel, Estelle Boivin, Vincent Jullien, et al.. Levetiracetam optimal dose-finding as first-line treatment for neonatal seizures occurring in the context of hypoxic-ischaemic encephalopathy (LEVNEONAT-1) study protocol of a phase II trial. BMJ Open, 2019, 9 (1), pp.e022739. ⟨10.1136/bmjopen-2018-022739⟩. ⟨hal-02049819⟩

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Sandrine Boulet, Moreno Ursino, Peter F Thall, Anne-Sophie Jannot, Sarah Zohar. Bayesian variable selection based on clinical relevance weights in small sample studies—Application to colon cancer. Statistics in Medicine, 2019, 38 (12), pp.2228-2247. ⟨10.1002/sim.8107⟩. ⟨hal-02120840⟩

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Thomas Schmitz, Corinne Alberti, Moreno Ursino, Olivier Baud, Camille Aupiais. Full versus half dose of antenatal betamethasone to prevent severe neonatal respiratory distress syndrome associated with preterm birth: study protocol for a randomised, multicenter, double blind, placebo-controlled, non-inferiority trial (BETADOSE). BMC Pregnancy and Childbirth, 2019, 19, pp.67. ⟨10.1186/s12884-019-2206-x⟩. ⟨hal-02052145⟩

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2018

Journal articles

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Tim Friede, Martin Posch, Sarah Zohar, Corinne Alberti, Norbert Benda, et al.. Recent advances in methodology for clinical trials in small populations the InSPiRe project. Orphanet Journal of Rare Diseases, 2018, 13 (1), pp.186. ⟨10.1186/s13023-018-0919-y⟩. ⟨hal-01935072⟩

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Caroline Petit, Adeline Samson, Satoshi Morita, Moreno Ursino, Vincent Jullien, et al.. Unified approach for extrapolation and bridging of adult information in early-phase dose-finding paediatric studies. Statistical Methods in Medical Research, 2018, 27 (6), pp.1860-1877. ⟨10.1177/0962280216671348⟩. ⟨hal-01623760⟩

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Moreno Ursino, Mauro Gasparini. A new parsimonious model for ordinal longitudinal data with application to subjective evaluations of a gastrointestinal disease. Statistical Methods in Medical Research, 2018, 27 (5), pp.1376-1393. ⟨10.1177/0962280216661370⟩. ⟨hal-03873777⟩

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Tim Friede, Corinne Alberti, Norbert Benda, Emmanuelle Comets, Alex Dmitrienko, et al.. Approaches to sample size calculation for clinical trials in rare diseases. Pharmaceutical Statistics, 2018, 17 (3), pp.214-230. ⟨10.1002/pst.1848⟩. ⟨inserm-02456642⟩

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2017

Journal articles

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Moreno Ursino, Sarah Zohar, Frederike Lentz, Corinne Alberti, Tim Friede, et al.. Dose-finding methods for Phase I clinical trials using pharmacokinetics in small populations. Biometrical Journal, 2017, 59 (4), pp.804-825. ⟨10.1002/bimj.201600084⟩. ⟨hal-01560222⟩

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Peter F Thall, Moreno Ursino, Véronique Baudouin, Corinne Alberti, Sarah Zohar. Bayesian treatment comparison using parametric mixture priors computed from elicited histograms. Statistical Methods in Medical Research, 2017, 28 (2), pp.404-418. ⟨10.1177/0962280217726803⟩. ⟨hal-02016667⟩

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