Understanding MCP-MOD dose finding as a method based on linear regression.
Sign Up to like & getrecommendations! Published in 2017 at "Statistics in medicine"
DOI: 10.1002/sim.7424
Abstract: MCP-MOD is a testing and model selection approach for clinical dose finding studies. During testing, contrasts of dose group means are derived from candidate dose response models. A multiple-comparison procedure is applied that controls the… read more here.
Keywords: dose finding; mcp mod; model; linear regression ... See more keywords
STEIN: A simple toxicity and efficacy interval design for seamless phase I/II clinical trials.
Sign Up to like & getrecommendations! Published in 2017 at "Statistics in medicine"
DOI: 10.1002/sim.7428
Abstract: 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 sophisticated yet untestable models to quantify dose-toxicity and dose-efficacy relationships, which always… read more here.
Keywords: toxicity; phase; interval design; dose finding ... See more keywords
Subgroup identification in dose-finding trials via model-based recursive partitioning.
Sign Up to like & getrecommendations! Published in 2018 at "Statistics in medicine"
DOI: 10.1002/sim.7594
Abstract: An important task in early-phase drug development is to identify patients, which respond better or worse to an experimental treatment. While a variety of different subgroup identification methods have been developed for the situation of… read more here.
Keywords: model based; dose finding; recursive partitioning; subgroup identification ... See more keywords
Incorporating patient-reported outcomes in dose-finding clinical trials.
Sign Up to like & getrecommendations! Published in 2019 at "Statistics in medicine"
DOI: 10.1002/sim.8402
Abstract: Oncology dose-finding clinical trials determine the maximum tolerated dose (MTD) based on toxicity outcomes captured by clinicians. With the availability of more rigorous instruments for measuring toxicity directly from patients, there is a growing interest… read more here.
Keywords: reported outcomes; dose finding; clinical trials; patient ... See more keywords
Early phase dose-finding trials in virology.
Sign Up to like & getrecommendations! Published in 2020 at "Statistics in medicine"
DOI: 10.1002/sim.8771
Abstract: Little has been published in terms of dose-finding methodology in virology. Aside from a few papers focusing on HIV, the considerable progress in dose-finding methodology of the last 25 years has focused almost entirely on… read more here.
Keywords: methodology; virology; dose finding; early phase ... See more keywords
Subgroup-specific dose finding for phase I-II trials using Bayesian clustering.
Sign Up to like & getrecommendations! Published in 2022 at "Statistics in medicine"
DOI: 10.1002/sim.9410
Abstract: In most models and algorithms for dose-finding clinical trials, it is assumed that the trial participants are homogeneous-the optimal dose is the same for all those who qualify for the trial. However, if there are… read more here.
Keywords: bayesian clustering; dose finding; methodology; subgroup specific ... See more keywords
A Bayesian interval dose-finding design addressingOckham's razor: mTPI-2.
Sign Up to like & getrecommendations! Published in 2017 at "Contemporary clinical trials"
DOI: 10.1016/j.cct.2017.04.006
Abstract: There has been an increasing interest in using interval-based Bayesian designs for dose finding, one of which is the modified toxicity probability interval (mTPI) method. We show that the decision rules in mTPI correspond to… read more here.
Keywords: razor; bayesian interval; dose finding; interval ... See more keywords
Efficacy/toxicity dose-finding using hierarchical modeling for multiple populations.
Sign Up to like & getrecommendations! Published in 2018 at "Contemporary clinical trials"
DOI: 10.1016/j.cct.2018.06.012
Abstract: Traditionally, Phase I oncology trials evaluate the safety profile of a novel agent and identify a maximum tolerable dose based on toxicity alone. With the development of biologically targeted agents, investigators believe the efficacy of… read more here.
Keywords: multiple populations; dose finding; toxicity; hierarchical modeling ... See more keywords
Hi3 + 3: A model-assisted dose-finding design borrowing historical data.
Sign Up to like & getrecommendations! Published in 2021 at "Contemporary clinical trials"
DOI: 10.1016/j.cct.2021.106437
Abstract: BACKGROUND In phase I clinical trials, historical data may be available through multi-regional programs, reformulation of the same drug, or previous trials for a drug under the same class. Statistical designs that borrow information from… read more here.
Keywords: dose finding; borrowing historical; historical data; safety ... See more keywords
Controlled backfill in oncology dose-finding trials.
Sign Up to like & getrecommendations! Published in 2021 at "Contemporary clinical trials"
DOI: 10.1016/j.cct.2021.106605
Abstract: The use of backfill in early phase dose-finding trials is a relatively recent practice. It consists of assigning patients to dose levels below the level where the study is at. The main reason for backfilling… read more here.
Keywords: dose finding; dose level; finding trials; patients dose ... See more keywords
A rule-based, dose-finding design for use in stroke rehabilitation research: methodological development.
Sign Up to like & getrecommendations! Published in 2017 at "Physiotherapy"
DOI: 10.1016/j.physio.2016.10.393
Abstract: BACKGROUND Dose-optimisation studies as precursors to clinical trials are rare in stroke rehabilitation. OBJECTIVE To develop a rule-based, dose-finding design for stroke rehabilitation research. DESIGN 3+3 rule-based, dose-finding study. Dose escalation/de-escalation was undertaken according to… read more here.
Keywords: dose finding; rule based; stroke rehabilitation; based dose ... See more keywords