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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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Official URL: http://dx.doi.org/10.1111/rssc.12289

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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
Subjects: R Medicine > RJ Pediatrics
Divisions: Faculty of Medicine > Warwick Medical School > Health Sciences > Statistics and Epidemiology
Faculty of Medicine > Warwick Medical School
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:
DateEvent
February 2019Published
18 May 2018Available
9 April 2018Accepted
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:
Project/Grant IDRIOXX Funder NameFunder ID
FP HEALTH 2013-602144FP7 Healthhttp://dx.doi.org/10.13039/100011272

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