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A dose finding design for seizure reduction in neonates
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Ursino, Moreno, Yuan, Ying, Alberti, Corinne, Comets, Emmanuelle, Favrais, Geraldine, Friede, Tim, Lentz, Frederike, Stallard, Nigel and Zohar, Sarah (2019) A dose finding design for seizure reduction in neonates. Journal of the Royal Statistical Society: Series C (Applied Statistics), 68 (2). pp. 427-444. doi:10.1111/rssc.12289
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WRAP-dose-finding-design-seizure-neonates-Stallard-2018.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons: Attribution-Noncommercial 4.0. Download (951Kb) | Preview |
Official URL: http://dx.doi.org/10.1111/rssc.12289
Abstract
Clinical trials in vulnerable populations are extremely difficult to conduct. A sequential phase I–II trial aimed at finding the appropriate dose of levetiracetam for treating neonatal seizures was planned with a maximum sample size of 50 newborns. Three primary outcomes are considered: efficacy and two types of toxicity that occur at the same time but are measured at different time points. In the case of failure, physicians could add a second agent as a rescue medication. The primary outcomes were modelled via a logistic model for efficacy and a weighted likelihood with pseudo‐outcomes for the two toxicities taking into account the dependences under Bayesian inference. Simulations were conducted to assess the design properties.
| Item Type: | Journal Article | ||||||||
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| Subjects: | R Medicine > RJ Pediatrics | ||||||||
| Divisions: | Faculty of Medicine > Warwick Medical School > Health Sciences > Statistics and Epidemiology Faculty of Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Pediatric pharmacology, Newborn infants -- Effect of drugs on, Drugs -- Dosage, Drugs -- Testing, Spasms, Infantile -- Prevention | ||||||||
| Journal or Publication Title: | Journal of the Royal Statistical Society: Series C (Applied Statistics) | ||||||||
| Publisher: | Wiley-Blackwell Publishing Ltd. | ||||||||
| ISSN: | 0035-9254 | ||||||||
| Official Date: | February 2019 | ||||||||
| Dates: |
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| Volume: | 68 | ||||||||
| Number: | 2 | ||||||||
| Page Range: | pp. 427-444 | ||||||||
| DOI: | 10.1111/rssc.12289 | ||||||||
| Status: | Peer Reviewed | ||||||||
| Publication Status: | Published | ||||||||
| Access rights to Published version: | Open Access | ||||||||
| RIOXX Funder/Project Grant: |
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