Phase II Trials in Drug Development and Adaptive Trial Design

Phase II clinical studies represent a critical point in determining drug costs, and phase II is a poor predictor of drug success: >30% of drugs entering phase II studies fail to progress, and >58% of drugs go on to fail in phase III. Adaptive clinical trial design has been proposed as a way to...

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Detalles Bibliográficos
Autor principal: Van Norman, Gail A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2019
Materias:
TRANSLATIONAL TOOLBOX
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6609997/
https://www.ncbi.nlm.nih.gov/pubmed/31312766
http://dx.doi.org/10.1016/j.jacbts.2019.02.005
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author Van Norman, Gail A.
author_facet Van Norman, Gail A.
author_sort Van Norman, Gail A.
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description Phase II clinical studies represent a critical point in determining drug costs, and phase II is a poor predictor of drug success: >30% of drugs entering phase II studies fail to progress, and >58% of drugs go on to fail in phase III. Adaptive clinical trial design has been proposed as a way to reduce the costs of phase II testing by providing earlier determination of futility and prediction of phase III success, reducing overall phase II and III trial sizes, and shortening overall drug development time. This review examines issues in phase II testing and adaptive trial design.
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spelling pubmed-66099972019-07-16 Phase II Trials in Drug Development and Adaptive Trial Design Van Norman, Gail A. JACC Basic Transl Sci TRANSLATIONAL TOOLBOX Phase II clinical studies represent a critical point in determining drug costs, and phase II is a poor predictor of drug success: >30% of drugs entering phase II studies fail to progress, and >58% of drugs go on to fail in phase III. Adaptive clinical trial design has been proposed as a way to reduce the costs of phase II testing by providing earlier determination of futility and prediction of phase III success, reducing overall phase II and III trial sizes, and shortening overall drug development time. This review examines issues in phase II testing and adaptive trial design. Elsevier 2019-06-24 /pmc/articles/PMC6609997/ /pubmed/31312766 http://dx.doi.org/10.1016/j.jacbts.2019.02.005 Text en © 2019 The Authors http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle TRANSLATIONAL TOOLBOX
Van Norman, Gail A.
Phase II Trials in Drug Development and Adaptive Trial Design
title Phase II Trials in Drug Development and Adaptive Trial Design
title_full Phase II Trials in Drug Development and Adaptive Trial Design
title_fullStr Phase II Trials in Drug Development and Adaptive Trial Design
title_full_unstemmed Phase II Trials in Drug Development and Adaptive Trial Design
title_short Phase II Trials in Drug Development and Adaptive Trial Design
title_sort phase ii trials in drug development and adaptive trial design
topic TRANSLATIONAL TOOLBOX
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6609997/
https://www.ncbi.nlm.nih.gov/pubmed/31312766
http://dx.doi.org/10.1016/j.jacbts.2019.02.005
work_keys_str_mv AT vannormangaila phaseiitrialsindrugdevelopmentandadaptivetrialdesign

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