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PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms
Adaptive, seamless, multisponsor, multitherapy clinical trial designs executed as large scale platforms, could create superior evidence more efficiently than single‐sponsor, single‐drug trials. These trial PIPELINEs also could diminish barriers to trial participation, increase the representation of...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5142736/ https://www.ncbi.nlm.nih.gov/pubmed/27643536 http://dx.doi.org/10.1002/cpt.514 |
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author | Trusheim, MR Shrier, AA Antonijevic, Z Beckman, RA Campbell, RK Chen, C Flaherty, KT Loewy, J Lacombe, D Madhavan, S Selker, HP Esserman, LJ |
author_facet | Trusheim, MR Shrier, AA Antonijevic, Z Beckman, RA Campbell, RK Chen, C Flaherty, KT Loewy, J Lacombe, D Madhavan, S Selker, HP Esserman, LJ |
author_sort | Trusheim, MR |
collection | PubMed |
description | Adaptive, seamless, multisponsor, multitherapy clinical trial designs executed as large scale platforms, could create superior evidence more efficiently than single‐sponsor, single‐drug trials. These trial PIPELINEs also could diminish barriers to trial participation, increase the representation of real‐world populations, and create systematic evidence development for learning throughout a therapeutic life cycle, to continually refine its use. Comparable evidence could arise from multiarm design, shared comparator arms, and standardized endpoints—aiding sponsors in demonstrating the distinct value of their innovative medicines; facilitating providers and patients in selecting the most appropriate treatments; assisting regulators in efficacy and safety determinations; helping payers make coverage and reimbursement decisions; and spurring scientists with translational insights. Reduced trial times and costs could enable more indications, reduced development cycle times, and improved system financial sustainability. Challenges to overcome range from statistical to operational to collaborative governance and data exchange. |
format | Online Article Text |
id | pubmed-5142736 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-51427362016-12-16 PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms Trusheim, MR Shrier, AA Antonijevic, Z Beckman, RA Campbell, RK Chen, C Flaherty, KT Loewy, J Lacombe, D Madhavan, S Selker, HP Esserman, LJ Clin Pharmacol Ther State of the Art Adaptive, seamless, multisponsor, multitherapy clinical trial designs executed as large scale platforms, could create superior evidence more efficiently than single‐sponsor, single‐drug trials. These trial PIPELINEs also could diminish barriers to trial participation, increase the representation of real‐world populations, and create systematic evidence development for learning throughout a therapeutic life cycle, to continually refine its use. Comparable evidence could arise from multiarm design, shared comparator arms, and standardized endpoints—aiding sponsors in demonstrating the distinct value of their innovative medicines; facilitating providers and patients in selecting the most appropriate treatments; assisting regulators in efficacy and safety determinations; helping payers make coverage and reimbursement decisions; and spurring scientists with translational insights. Reduced trial times and costs could enable more indications, reduced development cycle times, and improved system financial sustainability. Challenges to overcome range from statistical to operational to collaborative governance and data exchange. John Wiley and Sons Inc. 2016-10-19 2016-12 /pmc/articles/PMC5142736/ /pubmed/27643536 http://dx.doi.org/10.1002/cpt.514 Text en © 2016 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs (http://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | State of the Art Trusheim, MR Shrier, AA Antonijevic, Z Beckman, RA Campbell, RK Chen, C Flaherty, KT Loewy, J Lacombe, D Madhavan, S Selker, HP Esserman, LJ PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms |
title | PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms |
title_full | PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms |
title_fullStr | PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms |
title_full_unstemmed | PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms |
title_short | PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms |
title_sort | pipelines: creating comparable clinical knowledge efficiently by linking trial platforms |
topic | State of the Art |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5142736/ https://www.ncbi.nlm.nih.gov/pubmed/27643536 http://dx.doi.org/10.1002/cpt.514 |
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