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 …

On multi-armed bandit designs for dose-finding trials

M Aziz, E Kaufmann, MK Riviere - Journal of Machine Learning Research, 2021 - jmlr.org
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 …

STEIN: A simple toxicity and efficacy interval design for seamless phase I/II clinical trials

R Lin, G Yin - Statistics in medicine, 2017 - Wiley Online Library
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 …

Best arm identification with safety constraints

Z Wang, AJ Wagenmaker… - … Conference on Artificial …, 2022 - proceedings.mlr.press
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 …

[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 …

gBOIN‐ET: The generalized Bayesian optimal interval design for optimal dose‐finding accounting for ordinal graded efficacy and toxicity in early clinical trials

K Takeda, S Morita, M Taguri - Biometrical Journal, 2022 - Wiley Online Library
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 …

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 …

Adaptive phase I–II clinical trial designs identifying optimal biological doses for targeted agents and immunotherapies

Y Zang, B Guo, Y Qiu, H Liu, M Opyrchal… - Clinical Trials, 2024 - journals.sagepub.com
Targeted agents and immunotherapies have revolutionized cancer treatment, offering
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

K Takeda, Y Yamaguchi, M Taguri… - Biometrical Journal, 2023 - Wiley Online Library
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 …

Bayesian adaptive model selection design for optimal biological dose finding in phase I/II clinical trials

R Lin, G Yin, H Shi - Biostatistics, 2023 - academic.oup.com
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 …