50 citations · 78 across the 13 of their papers we have counts for
14 papers
PK/PD-integrated Bayesian platform design for phase II dose regimen optimization
Axel Vuorinen, Antoine Guillon, Emmanuelle Comets +2
Early-phase dose-finding methods increasingly assess toxicity and efficacy jointly, but comparisons based only on administered dose may inadequately characterize regimens differing…
Conditional bootstrap for non-linear mixed effects models
Sofia Kaisaridi, Moreno Ursino, Emmanuelle Comets
Background and Objective: Uncertainty in non-linear mixed effect models is often assessed using the Fisher information matrix to derive the standard errors of estimation. The boots…
Latent Neural-ODE for Model-Informed Precision Dosing: Overcoming Structural Assumptions in Pharmacokinetics
Benjamin Maurel, Agathe Guilloux, Sarah Zohar +2
Accurate estimation of tacrolimus exposure, quantified by the area under the concentration-time curve (AUC), is essential for precision dosing after renal transplantation. Current…
Sample size reassessment in Bayesian hybrid clinical trials
Marco Ratta, Pavel Mozgunov, Sandrine Boulet +1
The use of historical controls offers a valuable alternative when traditional randomized controlled trials are not feasible. However, such approaches may introduce bias due to temp…
U-DESPE: a Bayesian Utility-based methodology for dosing regimen optimization in early-phase oncology trials based on Dose-Exposure, Safety, Pharmacodynamics, Efficacy
Anaïs Andrillon, Sandrine Micallef, Moreno Ursino +2
With the development of novel therapies such as molecularly targeted agents and immunotherapy, the maximum tolerated dose paradigm that "more is better" does not necessarily hold a…
In silico clinical trials in drug development: a systematic review
Bohua Chen, Lucia Chantal Schneider, Christian Röver +15
In the context of clinical research, computational models have received increasing attention over the past decades. In this systematic review, we aimed to provide an overview of th…
Straightforward Phase I Dose-Finding Design for Healthy Volunteers Accounting for Surrogate Activity Biomarkers
Sandrine Boulet, Emmanuelle Comets, Antoine Guillon +5
Conventionally, a first-in-human phase I trial in healthy volunteers aims to confirm the safety of a drug in humans. In such situations, volunteers should not suffer from any safet…
Bayesian Framework for Multi-Source Data Integration -- Application to Human Extrapolation From Preclinical Studies
Sandrine Boulet, Moreno Ursino, Robin Michelet +4
In preclinical investigations, e.g. in in vitro, in vivo and in silico studies, the pharmacokinetic, pharmacodynamic and toxicological characteristics of a drug are evaluated befor…
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 +9
Clinical trials disruption has always represented a non negligible part of the ending of interventional studies. While the SARS-CoV-2 (COVID-19) pandemic has led to an impressive a…
A straightforward meta-analysis approach for oncology phase I dose-finding studies
Christian Röver, Moreno Ursino, Tim Friede +1
Phase I early-phase clinical studies aim at investigating the safety and the underlying dose-toxicity relationship of a drug or combination. While little may still be known about t…
Bayesian model for early dose-finding in phase I trials with multiple treatment courses
Moreno Ursino, Lucie Biard, Sylvie Chevret
Dose-finding clinical trials in oncology aim to determine the maximum tolerated dose (MTD) of a new drug, generally defined by the proportion of patients with short-term dose-limit…
Bayesian dose-regimen assessment in early phase oncology incorporating pharmacokinetics and pharmacodynamics
Emma Gerard, Sarah Zohar, Hoai-Thu Thai +3
Phase I dose-finding trials in oncology seek to find the maximum tolerated dose (MTD) of a drug under a specific schedule. Evaluating drug-schedules aims at improving treatment saf…
Random-effects meta-analysis of phase I dose-finding studies using stochastic process priors
Moreno Ursino, Christian Röver, Sarah Zohar +1
Phase I dose-finding studies aim at identifying the maximal tolerated dose (MTD). It is not uncommon that several dose-finding studies are conducted, although often with some varia…
Recent advances in methodology for clinical trials in small populations: the InSPiRe project
T. Friede, M. Posch, S. Zohar +19
Where there are a limited number of patients, such as in a rare disease, clinical trials in these small populations present several challenges, including statistical issues. This l…