50 citations · 78 across the 13 of their papers we have counts for
8 papers · 1 filter
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…
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…
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…
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…