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Article: Seamless Phase IIa/IIb and enhanced dose-finding adaptive design

TitleSeamless Phase IIa/IIb and enhanced dose-finding adaptive design
Authors
KeywordsAdaptive design
dose finding
proof of concept
seamless design
utility
Issue Date2016
PublisherTaylor & Francis Inc. The Journal's web site is located at http://www.tandf.co.uk/journals/titles/10543406.asp
Citation
Journal of Biopharmaceutical Statistics, 2016, v. 26 n. 5, p. 912-923 How to Cite?
AbstractIn drug development, when the drug class has a relatively well-defined path to regulatory approval and the enrollment is slow with certain patient populations, one may want to consider combining studies of different phases. This article considers combining a proof of concept (POC) study and a dose-finding (DF) study with a control treatment. Conventional DF study designs sometimes are not efficient, or do not have a high probability to find the optimal dose(s) for Phase III trials. This article seeks more efficient DF strategies that allow the economical testing of more doses. Hypothetical examples are simulated to compare the proposed adaptive design vs. the conventional design based on different models of the overall quantitative representation of efficacy, safety, and tolerability. The results show that the proposed adaptive design tests more active doses with higher power and comparable or smaller sample size in a shorter overall study duration for POC and DF, compared with a conventional design.
Persistent Identifierhttp://hdl.handle.net/10722/281769
ISSN
2019 Impact Factor: 0.601
2015 SCImago Journal Rankings: 0.850
PubMed Central ID

 

DC FieldValueLanguage
dc.contributor.authorYuan, J-
dc.contributor.authorPang, H-
dc.contributor.authorTong, T-
dc.contributor.authorXi, D-
dc.contributor.authorGuo, W-
dc.contributor.authorMesenbrink, P-
dc.date.accessioned2020-03-27T04:22:19Z-
dc.date.available2020-03-27T04:22:19Z-
dc.date.issued2016-
dc.identifier.citationJournal of Biopharmaceutical Statistics, 2016, v. 26 n. 5, p. 912-923-
dc.identifier.issn1054-3406-
dc.identifier.urihttp://hdl.handle.net/10722/281769-
dc.description.abstractIn drug development, when the drug class has a relatively well-defined path to regulatory approval and the enrollment is slow with certain patient populations, one may want to consider combining studies of different phases. This article considers combining a proof of concept (POC) study and a dose-finding (DF) study with a control treatment. Conventional DF study designs sometimes are not efficient, or do not have a high probability to find the optimal dose(s) for Phase III trials. This article seeks more efficient DF strategies that allow the economical testing of more doses. Hypothetical examples are simulated to compare the proposed adaptive design vs. the conventional design based on different models of the overall quantitative representation of efficacy, safety, and tolerability. The results show that the proposed adaptive design tests more active doses with higher power and comparable or smaller sample size in a shorter overall study duration for POC and DF, compared with a conventional design.-
dc.languageeng-
dc.publisherTaylor & Francis Inc. The Journal's web site is located at http://www.tandf.co.uk/journals/titles/10543406.asp-
dc.relation.ispartofJournal of Biopharmaceutical Statistics-
dc.rightsAOM/Preprint Before Accepted: his article has been accepted for publication in [JOURNAL TITLE], published by Taylor & Francis. AOM/Preprint After Accepted: This is an [original manuscript / preprint] of an article published by Taylor & Francis in [JOURNAL TITLE] on [date of publication], available online: http://www.tandfonline.com/[Article DOI]. Accepted Manuscript (AM) i.e. Postprint This is an Accepted Manuscript of an article published by Taylor & Francis in [JOURNAL TITLE] on [date of publication], available online: http://www.tandfonline.com/[Article DOI].-
dc.subjectAdaptive design-
dc.subjectdose finding-
dc.subjectproof of concept-
dc.subjectseamless design-
dc.subjectutility-
dc.titleSeamless Phase IIa/IIb and enhanced dose-finding adaptive design-
dc.typeArticle-
dc.identifier.emailPang, H: herbpang@hku.hk-
dc.identifier.authorityPang, H=rp01857-
dc.description.naturelink_to_OA_fulltext-
dc.identifier.doi10.1080/10543406.2015.1094807-
dc.identifier.pmid26390951-
dc.identifier.pmcidPMC5025390-
dc.identifier.scopuseid_2-s2.0-84958045323-
dc.identifier.hkuros309587-
dc.identifier.volume26-
dc.identifier.issue5-
dc.identifier.spage912-
dc.identifier.epage923-
dc.publisher.placeUnited States-

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