Seamless phase IIa/IIb adaptive design with the same primary endpoint for proof of concept and dose finding

This paper considers combining a proof of concept (POC) study and a dose finding (DF) study where the POC and the DF share the same primary endpoint. An example based on real study conditions shows that compared to a conventional design the proposed adaptive design tests more active doses, with a sm...

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Detalles Bibliográficos
Autores principales: Yuan, Jiacheng, Radecki, Daniel, Bugarin, Denise, Geib, Till, Zhou, Jihao, Liu, Jeen
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2018
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6039539/
https://www.ncbi.nlm.nih.gov/pubmed/30003170
http://dx.doi.org/10.1016/j.conctc.2018.06.006
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author Yuan, Jiacheng
Radecki, Daniel
Bugarin, Denise
Geib, Till
Zhou, Jihao
Liu, Jeen
author_facet Yuan, Jiacheng
Radecki, Daniel
Bugarin, Denise
Geib, Till
Zhou, Jihao
Liu, Jeen
author_sort Yuan, Jiacheng
collection PubMed
description This paper considers combining a proof of concept (POC) study and a dose finding (DF) study where the POC and the DF share the same primary endpoint. An example based on real study conditions shows that compared to a conventional design the proposed adaptive design tests more active doses, with a smaller sample size and a shorter overall duration leading to a budget saving of 30% in study operations.
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spelling pubmed-60395392018-07-12 Seamless phase IIa/IIb adaptive design with the same primary endpoint for proof of concept and dose finding Yuan, Jiacheng Radecki, Daniel Bugarin, Denise Geib, Till Zhou, Jihao Liu, Jeen Contemp Clin Trials Commun Article This paper considers combining a proof of concept (POC) study and a dose finding (DF) study where the POC and the DF share the same primary endpoint. An example based on real study conditions shows that compared to a conventional design the proposed adaptive design tests more active doses, with a smaller sample size and a shorter overall duration leading to a budget saving of 30% in study operations. Elsevier 2018-06-18 /pmc/articles/PMC6039539/ /pubmed/30003170 http://dx.doi.org/10.1016/j.conctc.2018.06.006 Text en © 2018 The Authors. Published by Elsevier Inc. http://creativecommons.org/licenses/by/4.0/ This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Yuan, Jiacheng
Radecki, Daniel
Bugarin, Denise
Geib, Till
Zhou, Jihao
Liu, Jeen
Seamless phase IIa/IIb adaptive design with the same primary endpoint for proof of concept and dose finding
title Seamless phase IIa/IIb adaptive design with the same primary endpoint for proof of concept and dose finding
title_full Seamless phase IIa/IIb adaptive design with the same primary endpoint for proof of concept and dose finding
title_fullStr Seamless phase IIa/IIb adaptive design with the same primary endpoint for proof of concept and dose finding
title_full_unstemmed Seamless phase IIa/IIb adaptive design with the same primary endpoint for proof of concept and dose finding
title_short Seamless phase IIa/IIb adaptive design with the same primary endpoint for proof of concept and dose finding
title_sort seamless phase iia/iib adaptive design with the same primary endpoint for proof of concept and dose finding
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6039539/
https://www.ncbi.nlm.nih.gov/pubmed/30003170
http://dx.doi.org/10.1016/j.conctc.2018.06.006
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