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Bridging the Gap Between RCTs and RWE Through Endpoint Selection

This commentary is authored by several industry real-world evidence (RWE) experts, with support from IQVIA, as part of the 'RWE Leadership Forum': a group of Industry Leaders who have come together as non-competitive partners to understand and respond to RWD/E challenges and opportunities...

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Autores principales: LoCasale, Robert J., Pashos, Chris L., Gutierrez, Ben, Dreyer, Nancy A., Collins, Toby, Calleja, Alan, Seewald, Michael J., Plumb, Jonathan M., Liwing, Johan, Tepie, Maurille Feudjo, Khosla, Sajan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7785541/
https://www.ncbi.nlm.nih.gov/pubmed/32632753
http://dx.doi.org/10.1007/s43441-020-00193-5
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author LoCasale, Robert J.
Pashos, Chris L.
Gutierrez, Ben
Dreyer, Nancy A.
Collins, Toby
Calleja, Alan
Seewald, Michael J.
Plumb, Jonathan M.
Liwing, Johan
Tepie, Maurille Feudjo
Khosla, Sajan
author_facet LoCasale, Robert J.
Pashos, Chris L.
Gutierrez, Ben
Dreyer, Nancy A.
Collins, Toby
Calleja, Alan
Seewald, Michael J.
Plumb, Jonathan M.
Liwing, Johan
Tepie, Maurille Feudjo
Khosla, Sajan
author_sort LoCasale, Robert J.
collection PubMed
description This commentary is authored by several industry real-world evidence (RWE) experts, with support from IQVIA, as part of the 'RWE Leadership Forum': a group of Industry Leaders who have come together as non-competitive partners to understand and respond to RWD/E challenges and opportunities with a single expert voice. Here, the forum discusses the value in bridging the industry disconnect between RTCs and RWE, with a view to promoting the use of RWE in the RCT environment. RCT endpoints are explored along several axes including their clinical relevance and their measure of direct patient benefit, and then compared with their real-world counterparts to identify suitable paths, or gaps, for assimilating RWE endpoints into the RCT environment.
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spelling pubmed-77855412021-01-11 Bridging the Gap Between RCTs and RWE Through Endpoint Selection LoCasale, Robert J. Pashos, Chris L. Gutierrez, Ben Dreyer, Nancy A. Collins, Toby Calleja, Alan Seewald, Michael J. Plumb, Jonathan M. Liwing, Johan Tepie, Maurille Feudjo Khosla, Sajan Ther Innov Regul Sci Commentary This commentary is authored by several industry real-world evidence (RWE) experts, with support from IQVIA, as part of the 'RWE Leadership Forum': a group of Industry Leaders who have come together as non-competitive partners to understand and respond to RWD/E challenges and opportunities with a single expert voice. Here, the forum discusses the value in bridging the industry disconnect between RTCs and RWE, with a view to promoting the use of RWE in the RCT environment. RCT endpoints are explored along several axes including their clinical relevance and their measure of direct patient benefit, and then compared with their real-world counterparts to identify suitable paths, or gaps, for assimilating RWE endpoints into the RCT environment. Springer International Publishing 2020-07-06 2021 /pmc/articles/PMC7785541/ /pubmed/32632753 http://dx.doi.org/10.1007/s43441-020-00193-5 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
spellingShingle Commentary
LoCasale, Robert J.
Pashos, Chris L.
Gutierrez, Ben
Dreyer, Nancy A.
Collins, Toby
Calleja, Alan
Seewald, Michael J.
Plumb, Jonathan M.
Liwing, Johan
Tepie, Maurille Feudjo
Khosla, Sajan
Bridging the Gap Between RCTs and RWE Through Endpoint Selection
title Bridging the Gap Between RCTs and RWE Through Endpoint Selection
title_full Bridging the Gap Between RCTs and RWE Through Endpoint Selection
title_fullStr Bridging the Gap Between RCTs and RWE Through Endpoint Selection
title_full_unstemmed Bridging the Gap Between RCTs and RWE Through Endpoint Selection
title_short Bridging the Gap Between RCTs and RWE Through Endpoint Selection
title_sort bridging the gap between rcts and rwe through endpoint selection
topic Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7785541/
https://www.ncbi.nlm.nih.gov/pubmed/32632753
http://dx.doi.org/10.1007/s43441-020-00193-5
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