José Luis Collada Jiménez

A Bayesian design for dual-agent dose optimization with targeted therapies

José Luis Collada Jiménez, Mourad Tighiouart

In this article, we propose a phase I-II design in two stages for the combination of molecularly targeted therapies. The design is motivated by a published case study that combines MEK and PIK3CA inhibitors; a setting in which higher dose levels do …

ch, us (code pays fourni par la source)

Visualizing hypothesis tests in survival analysis under anticipated delayed effects

José Luis Collada Jiménez, Isobel Barrott, Francesca Gasperoni, Dominic Magirr

Abstract What can be considered an appropriate statistical method for the primary analysis of a randomized clinical trial (RCT) with a time‐to‐event endpoint when we anticipate non‐proportional hazards owing to a delayed effect? This question has been the subject of much recent …

ch, gb (code pays fourni par la source)

A Bayesian adaptive design for dual‐agent phase I–II oncology trials integrating efficacy data across stages

José Luis Collada Jiménez, Haiyan Zheng

Combination of several anticancer treatments has typically been presumed to have enhanced drug activity. Motivated by a real clinical trial, this paper considers phase I-II dose finding designs for dual-agent combinations, where one main objective is to characterize both the toxicity and …

ch, gb (code pays fourni par la source)

Stratified modestly weighted log‐rank tests in settings with an anticipated delayed separation of survival curves

Dominic Magirr, José Luis Collada Jiménez

Delayed separation of survival curves is a common occurrence in confirmatory studies in immuno-oncology. Many novel statistical methods that aim to efficiently capture potential long-term survival improvements have been proposed in recent years. However, the vast majority do not consider stratification, which …

ch (code pays fourni par la source)

Modeling synergism in early phase cancer trials with drug combination with continuous dose levels: is there an added value?

Mourad Tighiouart, José Luis Collada Jiménez, Márcio A. Diniz, André Rogatko

In parametric Bayesian designs of early phase cancer clinical trials with drug combinations exploring a discrete set of partially ordered doses, several authors claimed that there is no added value in including an interaction term to model synergism between the two drugs. …

us, jp, ch, nl (code pays fourni par la source)

Combining Cytotoxic Agents with Continuous Dose Levels in Seamless Phase I-II Clinical Trials

José Luis Collada Jiménez, Mourad Tighiouart

Phase I-II cancer clinical trial designs are intended to accelerate drug development. In cases where efficacy cannot be ascertained in a short period of time, it is common to divide the study in two stages: i) a first stage in which dose …

ch, us (code pays fourni par la source)

Design and analysis of group-sequential clinical trials based on a modestly weighted log-rank test in anticipation of a delayed separation of survival curves: A practical guidance

Dominic Magirr, José Luis Collada Jiménez

BACKGROUND: A common feature of many recent trials evaluating the effects of immunotherapy on survival is that non-proportional hazards can be anticipated at the design stage. This raises the possibility to use a statistical method tailored towards testing the purported long-term benefit, …

ch (code pays fourni par la source)

A modified weighted log-rank test for confirmatory trials with a high proportion of treatment switching

José Luis Collada Jiménez, Julia Niewczas, Alexander Bore, Carl‐Fredrik Burman

In confirmatory cancer clinical trials, overall survival (OS) is normally a primary endpoint in the intention-to-treat (ITT) analysis under regulatory standards. After the tumor progresses, it is common that patients allocated to the control group switch to the experimental treatment, or another …

ch, se (code pays fourni par la source)

A Bayesian adaptive design for dual-agent phase I-II oncology trials integrating efficacy data across stages

José Luis Collada Jiménez, Haiyan Zheng

Combination of several anti-cancer treatments has typically been presumed to have enhanced drug activity. Motivated by a real clinical trial, this paper considers phase I-II dose finding designs for dual-agent combinations, where one main objective is to characterize both the toxicity and …

POS0277 ANABOLIC EFFECT OF LNA043, A NOVEL DISEASE-MODIFYING OSTEOARTHRITIS DRUG CANDIDATE: RESULTS FROM AN IMAGING-BASED PROOF-OF-CONCEPT TRIAL IN PATIENTS WITH FOCAL ARTICULAR CARTILAGE LESIONS

Siegfried Trattnig, Celeste Scotti, Didier Laurent, Scott A. Hacker et autres

at, ch, us, cz, de (code pays fourni par la source)

Designing group sequential clinical trials when a delayed effect is anticipated: A practical guidance

Dominic Magirr, José Luis Collada Jiménez

A common feature of many recent trials evaluating the effects of immunotherapy on survival is that non-proportional hazards can be anticipated at the design stage. This raises the possibility to use a statistical method tailored towards testing the purported long-term benefit, rather …

Designs of Early Phase Cancer Trials with Drug Combinations

José Luis Collada Jiménez, Márcio A. Diniz, André Rogatko, Mourad Tighiouart

ch, us (code pays fourni par la source)