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Statistical and practical considerations in planning and conduct of dose-optimization trials
Y Yuan, H Zhou, S Liu - Clinical Trials, 2024 - journals.sagepub.com
The US Food and Drug Administration launched Project Optimus with the aim of shifting the
paradigm of dose-finding and selection toward identifying the optimal biological dose that …
paradigm of dose-finding and selection toward identifying the optimal biological dose that …
On multi-armed bandit designs for dose-finding trials
We study the problem of finding the optimal dosage in early stage clinical trials through the
multiarmed bandit lens. We advocate the use of the Thompson Sampling principle, a flexible …
multiarmed bandit lens. We advocate the use of the Thompson Sampling principle, a flexible …
STEIN: A simple toxicity and efficacy interval design for seamless phase I/II clinical trials
Seamless phase I/II dose‐finding trials are attracting increasing attention nowadays in early‐
phase drug development for oncology. Most existing phase I/II dose‐finding methods use …
phase drug development for oncology. Most existing phase I/II dose‐finding methods use …
Best arm identification with safety constraints
The best arm identification problem in the multi-armed bandit setting is an excellent model of
many real-world decision-making problems, yet it fails to capture the fact that in the real …
many real-world decision-making problems, yet it fails to capture the fact that in the real …
[KNIHA][B] Model-assisted Bayesian designs for dose finding and optimization: methods and applications
Y Yuan, R Lin, JJ Lee - 2022 - taylorfrancis.com
Bayesian adaptive designs provide a critical approach to improve the efficiency and success
of drug development that has been embraced by the US Food and Drug Administration …
of drug development that has been embraced by the US Food and Drug Administration …
gBOIN‐ET: The generalized Bayesian optimal interval design for optimal dose‐finding accounting for ordinal graded efficacy and toxicity in early clinical trials
One of the primary objectives of an oncology dose‐finding trial for novel therapies, such as
molecular targeted agents and immune‐oncology therapies, is to identify an optimal dose …
molecular targeted agents and immune‐oncology therapies, is to identify an optimal dose …
Dose optimization for cancer treatments with considerations for late-onset toxicities
L Biard, A Andrillon, RB Silva, SM Lee - Clinical Trials, 2024 - journals.sagepub.com
Given that novel anticancer therapies have different toxicity profiles and mechanisms of
action, it is important to reconsider the current approaches for dose selection. In an effort to …
action, it is important to reconsider the current approaches for dose selection. In an effort to …
Adaptive phase I–II clinical trial designs identifying optimal biological doses for targeted agents and immunotherapies
Targeted agents and immunotherapies have revolutionized cancer treatment, offering
promising options for various cancer types. Unlike traditional therapies the principle of “more …
promising options for various cancer types. Unlike traditional therapies the principle of “more …
TITE‐gBOIN‐ET: Time‐to‐event generalized Bayesian optimal interval design to accelerate dose‐finding accounting for ordinal graded efficacy and toxicity outcomes
One of the primary objectives of an oncology dose‐finding trial for novel therapies, such as
molecular‐targeted agents and immune‐oncology therapies, is to identify an optimal dose …
molecular‐targeted agents and immune‐oncology therapies, is to identify an optimal dose …
Bayesian adaptive model selection design for optimal biological dose finding in phase I/II clinical trials
Identification of the optimal dose presents a major challenge in drug development with
molecularly targeted agents, immunotherapy, as well as chimeric antigen receptor T-cell …
molecularly targeted agents, immunotherapy, as well as chimeric antigen receptor T-cell …