PK/PD-integrated Bayesian platform design for phase II dose regimen optimization A Vuorinen, A Guillon, E Comets, M Ursino arXiv preprint arXiv:2609.30072, 2026
Analysis of the challenges in ensuring robust and effective clinical evaluation of AI-based digital medical devices S Boulet, V Thévenet, J Abecassis, C Collignon, B Giraudeau, E Lhomme, ... BMJ digital health & AI 2 (1), e000043, 2026
Eliciting clinical trial estimands for cystic fibrosis: a Bayesian framework W Shin, M Ursino, D Muilwijk, CK van der Ent, I Huys, S Zohar Journal of Cystic Fibrosis 25, S118, 2026
Conditional bootstrap for non-linear mixed effects models S Kaisaridi, M Ursino, E Comets arXiv preprint arXiv:2605.02534, 2026
Evaluation of the European Union Health Technology Assessment landscape and suggestion of tools to assess AI-based digital medical devices: Analyse de l’évaluation des … S Boulet, E Tavares, Y Binois, J Abecassis, M Boers, C Collignon, ... Journal of Epidemiology and Population Health 74, 203417, 2026
Comparison of two modelling approaches for two-population phase I/II dose-finding trials: Comparaison de deux approches de modélisation pour des essais de phase I/II de … J Meyring, M Ursino, S Chevret, L Biard Journal of Epidemiology and Population Health 74, 203404, 2026
Clinical trial evaluation of digital medical devices for clinical decision support: a simulation study: Évaluation en essai clinique des dispositifs médicaux numériques d’aide … B Archambaud, S Boulet, M Ursino, R Thiébaut, S Zohar Journal of Epidemiology and Population Health 74, 203415, 2026
When should the next clinical trial be conducted? A Bayesian borrowing approach for AI-based digital medical devices: Quand initier le prochain essai clinique? Une approche … C Lawless, S Boulet, M Ursino, R Thiébaut, S Zohar Journal of Epidemiology and Population Health 74, 203416, 2026
Innovative Clinical Trial Approach for Evaluating Digital Medical Devices Under European Fast‐Track Regulatory Frameworks M Ursino, S Boulet, C Collignon, F Francis‐Oliviero, E Lhomme, ... Statistics in Medicine 45 (10-12), e70572, 2026
A comparative analysis of Phase I dose-finding designs incorporating pharmacokinetics information A Vuorinen, E Comets, M Ursino The American Statistician 80 (2), 286-300, 2026
Prophylactic treatment of patent ductus arteriosus with acetaminophen: a randomized clinical trial JC Rozé, G Cambonie, C Flamant, J Patkaï, T Mühlbacher, G Gascoin, ... JAMA pediatrics 180 (4), 374-383, 2026
In silico clinical trials in drug development: a systematic review B Chen, LC Schneider, C Röver, E Comets, MC Elze, A Hooker, J IntHout, ... Therapeutic Innovation & Regulatory Science 60 (2), 423-439, 2026
Latent Neural-ODE for Model-Informed Precision Dosing: Overcoming Structural Assumptions in Pharmacokinetics B Maurel, A Guilloux, S Zohar, M Ursino, JB Woillard arXiv preprint arXiv:2602.03215, 2026
A novel workflow integrating whole-body PET microdosing data and therapeutic-dose pharmacokinetics across species to inform first-in-human dose selection BT Nguyen, A Barrail-Tran, M Ursino, S Goutal, F Caillé, T Naninck, ... bioRxiv, 2026.09. 03.748870, 2026
Sample size reassessment in Bayesian hybrid clinical trials M Ratta, P Mozgunov, S Boulet, M Ursino arXiv preprint arXiv:2512.19853, 2025
U-DESPE: a Bayesian Utility-based methodology for dosing regimen optimization in early-phase oncology trials based on Dose-Exposure, Safety, Pharmacodynamics, Efficacy A Andrillon, S Micallef, M Ursino, P Mozgunov, MK Riviere arXiv preprint arXiv:2511.17376, 2025
Modeling Whole-Body Dynamic PET Microdosing Data to Predict the Whole-Body Pharmacokinetics of Glyburide in Humans: L. Comin et al. L Comin, S Marie, M Ursino, S Zohar, N Tournier, E Comets Clinical Pharmacokinetics 64 (11), 1709-1722, 2025
Narrative review on the clinical evaluation of AI-based digital medical devices from a methodological perspective S Boulet, V Thévenet, J Abécassis, C Collignon, B Giraudeau, E Lhomme, ... SbN 2025-10th Statistics & Biopharmacy Conference, 2025
Digital pharmacological twins: Bridging multi-scale modelling and artificial intelligence for precision medicine: The DIGPHAT consortium JB Woillard, S Benzekry, J Josse, M White-Koning, E Chatelut, E Comets, ... Therapies, 2025
Modelling, Extrapolation and Simulation approaches for rare diseases-Review of two case-studies in the INVENTS project E Comets, M Ursino, Invents WP1. 1 group medRxiv, 2025.09. 17.25335979, 2025
Straightforward Phase I Dose-Finding Design for Healthy Volunteers Accounting for Surrogate Activity Biomarkers S Boulet, E Comets, A Guillon, LBS Aulin, R Michelet, C Kloft, S Zohar, ... Statistics in Biopharmaceutical Research 17 (3), 496-505, 2025
Effects of the right to be forgotten for childhood or breast cancer survivors: results of a quasi-experimental study in France N Bougas, TS Dabakuyo Yonli, E Assogba, N Haddy, F De Vathaire, ... Journal of Cancer Survivorship, 1-11, 2025
A seamless hybrid phase II/III design with bayesian interim subgroup selection B Duputel, N Stallard, F Montestruc, S Zohar, M Ursino Statistics in Medicine 44 (13-14), e70144, 2025
Stress Management in UHR Individuals: The STAR-T Randomised Controlled Trial V Lucarini, L Petersen, C Jantac, M Ursino, A Mansoux, M Charre, ... EARLY INTERVENTION IN PSYCHIATRY 19, 2025
P02-Innovative clinical trial approach for evaluating digital medical devices under European fast-track regulatory frameworks M Ursino, S Boulet, R Porcher, E Lhomme, F Francis-Oliviero, ... Journal of Epidemiology and Population Health 73, 203032, 2025
Modelling the whole-body pharmacokinetics of radiolabeled glyburide in healthy volunteers L Comin, S Marie, M Ursino, S Zohar, N Tournier, E Comets EMIM 2025-20th European Molecular Imaging Meeting, 2025
Modélisation de la pharmacocinétique sur corps entier (WBPK) de microdose du glyburide radiomarqué (11C-glyburide) chez des volontaires sains L Comin, S Marie, M Ursino, S Zohar, N Tournier, E Comets Médecine Nucléaire 49 (2), 135, 2025
TREOCAPA: prophylactic treatment of the ductus arteriosus in preterm infants by acetaminophen—statistical analysis plan for the randomized phase III group sequential trial M Ursino, C Alberti, G Cambonie, R Kemp, A Vanhecke, L Levoyer, ... Trials 26 (1), 52, 2025
SPIRIT-DEFINE explanation and elaboration: recommendations for enhancing quality and impact of early phase dose-finding clinical trials protocols M Ursino, G Villacampa, J Rekowski, M Dimairo, O Solovyeva, D Ashby, ... EClinicalMedicine 79, 2025
CONSORT-DEFINE explanation and elaboration: recommendations for enhancing reporting quality and impact of early phase dose-finding clinical trials J Rekowski, C Guo, O Solovyeva, M Dimairo, M Rouhifard, D Patel, ... EClinicalMedicine 79, 2025
Meta‐analyses of phase I dose‐finding studies: Application for the development of protein kinase inhibitors in oncology L Caquelin, P Badra, L Poulain, B Laviolle, M Ursino, C Locher Research Synthesis Methods 15 (6), 964-977, 2024
Home-Based Connected Devices Combined With Statistical Process Control for the Early Detection of Respiratory Exacerbations by Patients With Cystic Fibrosis: Pilot … E Le Roux, M Ursino, I Milovanovic, P Picq, J Haignere, G Rault, ... JMIR Formative Research 8, e51753, 2024
Survival without severe neonatal morbidity after antenatal betamethasone dose reduction: a post hoc analysis of a randomized non-inferiority trial O Baud, L Sentilhes, M Ursino, M Doret-Dion, C Alberti, C Aupiais, ... American Journal of Obstetrics and Gynecology 231 (4), 458. e1-458. e16, 2024
Enhancing Clinical Development-Bayesian Methods and Mathematical Modeling for Leveraging Available Information M Ursino Univerité Paris Cité, 2024
Modelling the whole-body pharmacokinetics (WBPK) of radiolabeled glyburide in healthy volunteers L Comin, S Marie, M Ursino, S Zohar, N Tournier, E Comets PAGE meeting 2024-Thirty-second meeting, 2024
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 S Calderazzo, S Tarima, C Reid, N Flournoy, T Friede, N Geller, ... Statistics in Biopharmaceutical Research 16 (2), 141-157, 2024
Bayesian framework for multi-source data integration-Application to human extrapolation from preclinical studies S Boulet, M Ursino, R Michelet, LBS Aulin, C Kloft, E Comets, S Zohar Statistical methods in medical research 33 (4), 574-588, 2024
Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance C Yap, O Solovyeva, J de Bono, J Rekowski, D Patel, T Jaki, A Mander, ... bmj 383, 2023
Enhancing quality and impact of early phase dose-finding clinical trial protocols: SPIRIT Dose-finding Extension (SPIRIT-DEFINE) guidance C Yap, J Rekowski, M Ursino, O Solovyeva, D Patel, M Dimairo, CJ Weir, ... bmj 383, 2023
Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study O Solovyeva, M Dimairo, CJ Weir, SW Hee, A Espinasse, M Ursino, ... BMC medicine 21 (1), 246, 2023
P163-Meta-analysis of phase I dose-finding studies: application for protein kinase inhibitors developed in oncology L Caquelin, P Badra, B Laviolle, M Ursino, C Locher Revue d'Épidémiologie et de Santé Publique 71, 101816, 2023
Using dichotomized survival data to construct a prior distribution for a Bayesian seamless Phase II/III clinical trial B Duputel, N Stallard, F Montestruc, S Zohar, M Ursino Statistical Methods in Medical Research 32 (5), 963-977, 2023
Development process of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE (DosE FIndiNg Extensions) study O Solovyeva, M Dimairo, C Weir, S Hee, M Ursino, A Espinasse, D Patel, ... OSF, 2023
Implementation of a centralized pharmacovigilance system in academic pan‐European clinical trials: Experience from EU‐Response and conect4children consortia V Terzić, L Levoyer, M Figarella, E Bigagli, N Mercier, L De Gastines, ... British Journal of Clinical Pharmacology 89 (4), 1318-1328, 2023
79MO Developing international consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding clinical trials: The DEFINE (DosE FIndiNg Extensions) study O Solovyeva, M Dimairo, C Weir, JS de Bono, A Bedding, AW Chan, ... ESMO Open 8 (1), 2023
Devenir néonatal à la sortie de l’hôpital après une réduction de 50% de la dose de bétaméthasone prénatale: analyse post-hoc de l’essai BETADOSE T Schmitz, L Sentilhes, M Doret-Dion, C Alberti, M Ursino, C Aupiais, ... Perfectionnement en Pédiatrie 6 (1), 85, 2023
Postoperative analgesia after surgical repair of distal radius fracture: a randomized comparison between distal peripheral nerve blockade and surgical site infiltration. D Sciard, K Xu, A Soulier, G Dufour, M Ursino, C Alberti, M Beaussier Minerva anestesiologica 89 (10), 876-883, 2023
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 M Cotinat, I Boquet, M Ursino, C Brocard, E Jouve, C Alberti, ... PloS one 18 (1), e0276892, 2023
DICE: A Bayesian model for early dose finding in phase I trials with multiple treatment courses M Ursino, L Biard, S Chevret Biometrical Journal 64 (8), 1486-1497, 2022
A straightforward meta‐analysis approach for oncology phase I dose‐finding studies C Röver, M Ursino, T Friede, S Zohar Statistics in Medicine 41 (20), 3915-3940, 2022
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 … T Schmitz, M Doret-Dion, L Sentilhes, O Parant, O Claris, L Renesme, ... The Lancet 400 (10352), 592-604, 2022
Bayesian framework for extrapolation from multi-source preclinical data to human S Boulet, M Ursino, R Michelet, LB Aulin, C Kloft, E Comets, S Zohar ISBA 2022-World Meeting International Society for Bayesian Analysis, 2022
Bayesian dose regimen assessment in early phase oncology incorporating pharmacokinetics and pharmacodynamics E Gerard, S Zohar, HT Thai, C Lorenzato, MK Riviere, M Ursino Biometrics 78 (1), 300-312, 2022
Bayesian modeling of a bivariate toxicity outcome for early phase oncology trials evaluating dose regimens E Gerard, S Zohar, C Lorenzato, M Ursino, M Riviere Statistics in Medicine 40 (23), 5096-5114, 2021
Impact of early corticosteroids on 60-day mortality in critically ill patients with COVID-19: A multicenter cohort study of the OUTCOMEREA network C Dupuis, E de Montmollin, N Buetti, D Goldgran-Toledano, J Reignier, ... PLoS One 16 (8), e0255644, 2021
Conditional Non-parametric Bootstrap for Non-linear Mixed Effect Models: Comets, Rodrigues, Jullien and Ursino E Comets, C Rodrigues, V Jullien, M Ursino Pharmaceutical Research 38 (6), 1057-1066, 2021
Seamless master protocol with account for correlations within subgroups B Duputel, S Zohar, F Montestruc, M Ursino Revue d'Épidémiologie et de Santé Publique 69, S14, 2021
Modélisation bayésienne d’une toxicité bivariée en essais de phase précoce en oncologie évaluant des régimes de dose E Gérard, S Zoha, M Ursino, M Rivière Revue d'Épidémiologie et de Santé Publique 69, S13-S14, 2021
Extrapolation bayésienne de la préclinique à la clinique S Boulet, M Ursino, R Michelet, C Kloft, E Comets, S Zohar Revue d'Épidémiologie et de Santé Publique 69, S13, 2021
The use of translational modelling and simulation to develop immunomodulatory therapy as an adjunct to antibiotic treatment in the context of pneumonia R Michelet, M Ursino, S Boulet, S Franck, F Casilag, M Baldry, J Rolff, ... Pharmaceutics 13 (5), 601, 2021
