[HTML][HTML] An overview of the BOIN design and its current extensions for novel early-phase oncology trials

R Ananthakrishnan, R Lin, C He, Y Chen, D Li… - Contemporary Clinical …, 2022 - Elsevier
Abstract Bayesian Optimal Interval (BOIN) designs are a class of model-assisted dose-
finding designs that can be used in oncology trials to determine the maximum tolerated dose …

[HTML][HTML] Challenges, opportunities, and innovative statistical designs for precision oncology trials

J Yin, S Shen, Q Shi - Annals of Translational Medicine, 2022 - ncbi.nlm.nih.gov
In the era of precision oncology, improved understanding of tumor heterogeneity, particularly
at the molecular level, has caused a shift from traditionally histology based cancer drug …

Incorporating historical information to improve dose optimization design with toxicity and efficacy endpoints: iBOIN‐ET

Y Zhao, R Liu, K Takeda - Pharmaceutical Statistics, 2023 - Wiley Online Library
In modern oncology drug development, adaptive designs have been proposed to identify the
recommended phase 2 dose. The conventional dose finding designs focus on the …

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 …

BOIN-ETC: A Bayesian optimal interval design considering efficacy and toxicity to identify the optimal dose combinations

T Kakizume, K Takeda, M Taguri… - Statistical Methods in …, 2024 - journals.sagepub.com
One of the primary objectives of a dose-finding trial for novel anti-cancer agent combination
therapies, such as molecular targeted agents and immune-oncology therapies, is to identify …

DOD-BART: machine learning-based dose optimization design incorporating patient-level prognostic factors via Bayesian additive regression trees

Y Zhao, R Liu, J Lin, A Chi, S Davies - Journal of …, 2024 - Taylor & Francis
Dose optimization is a critical stage of drug development in oncology and other disease
areas. Early phase clinical trials are inherently heterogeneous due to their exploratory …

Novel Oncology Dose-Finding Designs for the New Millennium

F Shen, R Ananthakrishnan, C He - Dose Finding and Beyond in …, 2024 - Springer
Dose-finding studies are a critical part of the drug development cycle in oncology. Between
the severity of the disease and the typical toxicity of the treatments, oncology trials need to …

A Model‐Based Trial Design With a Randomization Scheme Considering Pharmacokinetics Exposure for Dose Optimization in Oncology

J Zhang, K Takeda, M Takeuchi… - Pharmaceutical …, 2024 - Wiley Online Library
The primary purpose of an oncology dose‐finding trial for novel anticancer agents has been
shifting from determining the maximum tolerated dose to identifying an optimal dose (OD) …

A generalized Bayesian optimal interval design for dose optimization in immunotherapy

Q Xia, K Takeda, Y Yamaguchi… - Pharmaceutical …, 2024 - Wiley Online Library
For novel immuno‐oncology therapies, the primary purpose of a dose‐finding trial is to
identify an optimal dose (OD), defined as the tolerable dose having adequate efficacy and …

A Bayesian optimal interval design for dose optimization with a randomization scheme based on pharmacokinetics outcomes in oncology

K Takeda, J Zhu, R Li, Y Yamaguchi - Pharmaceutical Statistics, 2023 - Wiley Online Library
The primary objective of an oncology dose‐finding trial for novel therapies, such as
molecularly targeted agents and immune‐oncology therapies, is to identify the optimal dose …