Conditional borrowing external data to establish a hybrid control arm in randomized clinical trials
Sign Up to like & getrecommendations! Published in 2022 at "Journal of Biopharmaceutical Statistics"
DOI: 10.1080/10543406.2021.2021227
Abstract: ABSTRACT Utilizing external data from the real world, including data from historical clinical trials, has received increasing interest in drug development. The use of external data to support drug evaluation in clinical trials has mainly… read more here.
Keywords: arm; clinical trials; control; conditional borrowing ... See more keywords
A structured framework for adaptively incorporating external evidence in sequentially monitored clinical trials
Sign Up to like & getrecommendations! Published in 2022 at "Journal of Biopharmaceutical Statistics"
DOI: 10.1080/10543406.2022.2078346
Abstract: ABSTRACT We present a Bayesian framework for sequential monitoring that allows for use of external data, and that can be applied in a wide range of clinical trial applications. The basis for this framework is… read more here.
Keywords: sequential monitoring; trial; framework; monitoring ... See more keywords
Estimating the Observability of an Outcome from an Electronic Health Records Dataset Using External Data.
Sign Up to like & getrecommendations! Published in 2025 at "American journal of epidemiology"
DOI: 10.1093/aje/kwaf013
Abstract: One of the key limitations of electronic health records (EHR) data is that not all health care encounters are observed. The degree to which patient information is captured is referred to as observability. Poor observability,… read more here.
Keywords: external data; using external; electronic health; observability ... See more keywords
Identifying appropriate external control datasets in support of future glioblastoma clinical trials leveraging external data.
Sign Up to like & getrecommendations! Published in 2025 at "Neuro-oncology"
DOI: 10.1093/neuonc/noaf031
Abstract: BACKGROUND Recent interest in leveraging external data for clinical trial design and analysis in glioblastoma has raised questions on the identification of appropriate data to use as external controls for future trials. We perform a… read more here.
Keywords: external data; newly diagnosed; trial; glioblastoma ... See more keywords
Data Discernment for Affordable Training in Medical Image Segmentation
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DOI: 10.1109/tmi.2022.3228316
Abstract: Collecting sufficient high-quality training data for deep neural networks is often expensive or even unaffordable in medical image segmentation tasks. We thus propose to train the network by using external data that can be collected… read more here.
Keywords: image segmentation; data discernment; network; external data ... See more keywords
Extrapolating Survival from Randomized Trials Using External Data: A Review of Methods
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DOI: 10.1177/0272989x16639900
Abstract: This article describes methods used to estimate parameters governing long-term survival, or times to other events, for health economic models. Specifically, the focus is on methods that combine shorter-term individual-level survival data from randomized trials… read more here.
Keywords: term; extrapolating survival; external data; survival randomized ... See more keywords