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
Embracing model-based designs for dose-finding trials
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DOI: 10.1038/bjc.2017.186
Abstract: Background:Dose-finding trials are essential to drug development as they establish recommended doses for later-phase testing. We aim to motivate wider use of model-based designs for dose finding, such as the continual reassessment method (CRM).Methods:We carried… read more here.
Keywords: model based; based designs; designs dose; dose finding ... See more keywords
On the feasibility of pediatric dose-finding trials in small samples with information from a preceding trial in adults.
Sign Up to like & getrecommendations! Published in 2021 at "Journal of biopharmaceutical statistics"
DOI: 10.1080/10543406.2021.2011905
Abstract: We consider the case of pediatric dose-finding trials with extremely limited sample size. The operating characteristics of the standard design, the Continual Reassessment Method (CRM), are only well described for sample sizes of about 20… read more here.
Keywords: pediatric dose; trial; trial adults; feasibility pediatric ... See more keywords