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Mobilizing the clinical trial ecosystem to drive adoption of master protocols
Master protocol studies typically use an overarching protocol to answer several questions by guiding a variety of sub-studies. These sub-studies can incorporate multiple diseases, therapies, or both. Although this innovative approach offers many benefits, including the ability to deliver clinical re...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
SAGE Publications
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9679560/ https://www.ncbi.nlm.nih.gov/pubmed/36086812 http://dx.doi.org/10.1177/17407745221110199 |
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author | Bronson, Abby Chase, Marianne K Fisher, Kimberly Millar, Daniel Perlmutter, Jane Richardson, Nicholas |
author_facet | Bronson, Abby Chase, Marianne K Fisher, Kimberly Millar, Daniel Perlmutter, Jane Richardson, Nicholas |
author_sort | Bronson, Abby |
collection | PubMed |
description | Master protocol studies typically use an overarching protocol to answer several questions by guiding a variety of sub-studies. These sub-studies can incorporate multiple diseases, therapies, or both. Although this innovative approach offers many benefits, including the ability to deliver clinical research that is more patient-centric and efficient, several common barriers curtail widespread adoption. The Clinical Trials Transformation Initiative (CTTI) convened industry representatives, regulatory agencies, patient groups, and academic institutions to identify emerging best practices and develop resources designed to help sponsors and other stakeholders overcome these challenges. We first identify some broad changes needed in the clinical trials ecosystem to facilitate mainstream adoption of master protocol studies, and we subsequently summarize CTTI’s resources designed to support this effort. |
format | Online Article Text |
id | pubmed-9679560 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | SAGE Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-96795602022-11-23 Mobilizing the clinical trial ecosystem to drive adoption of master protocols Bronson, Abby Chase, Marianne K Fisher, Kimberly Millar, Daniel Perlmutter, Jane Richardson, Nicholas Clin Trials Perspective Master protocol studies typically use an overarching protocol to answer several questions by guiding a variety of sub-studies. These sub-studies can incorporate multiple diseases, therapies, or both. Although this innovative approach offers many benefits, including the ability to deliver clinical research that is more patient-centric and efficient, several common barriers curtail widespread adoption. The Clinical Trials Transformation Initiative (CTTI) convened industry representatives, regulatory agencies, patient groups, and academic institutions to identify emerging best practices and develop resources designed to help sponsors and other stakeholders overcome these challenges. We first identify some broad changes needed in the clinical trials ecosystem to facilitate mainstream adoption of master protocol studies, and we subsequently summarize CTTI’s resources designed to support this effort. SAGE Publications 2022-09-09 2022-12 /pmc/articles/PMC9679560/ /pubmed/36086812 http://dx.doi.org/10.1177/17407745221110199 Text en © The Author(s), 2022 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage). |
spellingShingle | Perspective Bronson, Abby Chase, Marianne K Fisher, Kimberly Millar, Daniel Perlmutter, Jane Richardson, Nicholas Mobilizing the clinical trial ecosystem to drive adoption of master protocols |
title | Mobilizing the clinical trial ecosystem to drive adoption of master
protocols |
title_full | Mobilizing the clinical trial ecosystem to drive adoption of master
protocols |
title_fullStr | Mobilizing the clinical trial ecosystem to drive adoption of master
protocols |
title_full_unstemmed | Mobilizing the clinical trial ecosystem to drive adoption of master
protocols |
title_short | Mobilizing the clinical trial ecosystem to drive adoption of master
protocols |
title_sort | mobilizing the clinical trial ecosystem to drive adoption of master
protocols |
topic | Perspective |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9679560/ https://www.ncbi.nlm.nih.gov/pubmed/36086812 http://dx.doi.org/10.1177/17407745221110199 |
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