Bayesian two-stage design for phase II oncology trials with binary endpoint.
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DOI: 10.1002/sim.9355
Abstract: In phase II oncology trials, two-stage design allowing early stopping for futility and/or efficacy is frequently used. However, this design based on frequentist statistical approaches could not guarantee a high posterior probability of attending the… read more here.
Keywords: oncology trials; two stage; phase oncology; oncology ... See more keywords
A Bayesian three-tier quantitative decision-making framework for single arm studies in early phase oncology
Sign Up to like & getrecommendations! Published in 2022 at "Journal of Biopharmaceutical Statistics"
DOI: 10.1080/10543406.2022.2089155
Abstract: ABSTRACT In early phase oncology drug development, single arm proof-of-concept (POC) studies are increasingly being used to drive the early decisions for future development of the drug. Decision-makings based on such studies, typically involving small… read more here.
Keywords: oncology; phase oncology; early phase; three tier ... See more keywords
The Use of Patient-Reported Outcome Measures in Phase I Oncology Clinical Trials
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DOI: 10.1159/000514874
Abstract: Objective: To investigate patient-reported outcome (PRO) usage in phase I oncology clinical trials, including types of PRO measures and changes over time. Methods: We analyzed ClinicalTrials.gov records of phase I oncology clinical trials completed by… read more here.
Keywords: reported outcome; phase oncology; oncology clinical; clinical trials ... See more keywords
Two-stage phase II oncology designs using short-term endpoints for early stopping
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DOI: 10.1177/0962280215585819
Abstract: Phase II oncology trials are conducted to evaluate whether the tumour activity of a new treatment is promising enough to warrant further investigation. The most commonly used approach in this context is a two-stage single-arm… read more here.
Keywords: two stage; phase oncology; oncology; stage ... See more keywords
Bridging across patient subgroups in phase I oncology trials that incorporate animal data
Sign Up to like & getrecommendations! Published in 2021 at "Statistical Methods in Medical Research"
DOI: 10.1177/0962280220986580
Abstract: In this paper, we develop a general Bayesian hierarchical model for bridging across patient subgroups in phase I oncology trials, for which preliminary information about the dose–toxicity relationship can be drawn from animal studies. Parameters… read more here.
Keywords: patient subgroups; phase oncology; bridging across; across patient ... See more keywords
Natural Language Processing for Patient Selection in Phase I or II Oncology Clinical Trials.
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DOI: 10.1200/cci.21.00003
Abstract: PURPOSE Early discontinuation affects more than one third of patients enrolled in early-phase oncology clinical trials. Early discontinuation is deleterious both for the patient and for the study, by inflating its duration and associated costs.… read more here.
Keywords: oncology clinical; phase oncology; consultation reports; clinical trials ... See more keywords
Race and ethnicity representation in clinical trials: findings from a literature review of Phase I oncology trials.
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DOI: 10.2217/fon-2020-1262
Abstract: Aim: To provide an assessment of published literature on the demographic representation in Phase I trials of biopharmaceutical oncology agents. Materials & methods: We conducted a rapid evidence assessment to identify demographic representation reported in… read more here.
Keywords: phase oncology; race ethnicity; clinical trials; oncology ... See more keywords