[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 …

BOIN‐ET: Bayesian optimal interval design for dose finding based on both efficacy and toxicity outcomes

K Takeda, M Taguri, S Morita - Pharmaceutical statistics, 2018 - Wiley Online Library
One of the main purposes of a phase I dose‐finding trial in oncology is to identify an optimal
dose (OD) that is both tolerable and has an indication of therapeutic benefit for subjects in …

A comparative study of Bayesian optimal interval (BOIN) design with interval 3+ 3 (i3+ 3) design for phase I oncology dose-finding trials

Y Zhou, R Li, F Yan, JJ Lee, Y Yuan - Statistics in …, 2021 - Taylor & Francis
Bayesian optimal interval (BOIN) design is a model-assisted phase I dose-finding design to
find the maximum tolerated dose. The hallmark of the BOIN design is its concise decision …

TITE‐BOIN‐ET: time‐to‐event Bayesian optimal interval design to accelerate dose‐finding based on both efficacy and toxicity outcomes

K Takeda, S Morita, M Taguri - Pharmaceutical statistics, 2020 - Wiley Online Library
One of the primary purposes of an oncology dose‐finding trial is to identify an optimal dose
(OD) that is both tolerable and has an indication of therapeutic benefit for subjects in …

Bayesian optimal interval designs for phase I clinical trials

S Liu, Y Yuan - Journal of the Royal Statistical Society: Series C …, 2015 - JSTOR
In phase I trials, effectively treating patients and minimizing the chance of exposing them to
subtherapeutic and overly toxic doses are clinicians' top priority. Motived by this practical …

BOIN: an R package for designing single-agent and drug-combination dose-finding trials using Bayesian optimal interval designs

F Yan, L Zhang, Y Zhou, H Pan, S Liu… - Journal of Statistical …, 2020 - jstatsoft.org
This article describes the R package BOIN, which implements a recently developed
methodology for designing single-agent and drug-combination dose-finding clinical trials …

Bayesian optimal interval design: a simple and well-performing design for phase I oncology trials

Y Yuan, KR Hess, SG Hilsenbeck, MR Gilbert - Clinical Cancer Research, 2016 - AACR
Despite more than two decades of publications that offer more innovative model-based
designs, the classical 3+ 3 design remains the most dominant phase I trial design in …

Bayesian optimal interval design with multiple toxicity constraints

R Lin - Biometrics, 2018 - academic.oup.com
Most phase I dose-finding trials are conducted based on a single binary toxicity outcome to
investigate the safety of new drugs. In many situations, however, it is important to distinguish …

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 …

A utility‐based Bayesian optimal interval (U‐BOIN) phase I/II design to identify the optimal biological dose for targeted and immune therapies

Y Zhou, JJ Lee, Y Yuan - Statistics in Medicine, 2019 - Wiley Online Library
In the era of targeted therapy and immunotherapy, the objective of dose finding is often to
identify the optimal biological dose (OBD), rather than the maximum tolerated dose. We …