Harnessing the Power of Real‐World Evidence (RWE): A Checklist to Ensure Regulatory‐Grade Data Quality

The role of real‐world evidence (RWE) in regulatory, drug development, and healthcare decision‐making is rapidly expanding. Recent advances have increased the complexity of cancer care and widened the gap between randomized clinical trial (RCT) results and the evidence needed for real‐world clinical...

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Detalles Bibliográficos
Autores principales: Miksad, Rebecca A., Abernethy, Amy P.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Development
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5814721/
https://www.ncbi.nlm.nih.gov/pubmed/29214638
http://dx.doi.org/10.1002/cpt.946
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author Miksad, Rebecca A.
Abernethy, Amy P.
author_facet Miksad, Rebecca A.
Abernethy, Amy P.
author_sort Miksad, Rebecca A.
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description The role of real‐world evidence (RWE) in regulatory, drug development, and healthcare decision‐making is rapidly expanding. Recent advances have increased the complexity of cancer care and widened the gap between randomized clinical trial (RCT) results and the evidence needed for real‐world clinical decisions.1 Instead of remaining invisible, data from the >95% of cancer patients treated outside of clinical trials can help fill this void.
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spelling pubmed-58147212018-02-21 Harnessing the Power of Real‐World Evidence (RWE): A Checklist to Ensure Regulatory‐Grade Data Quality Miksad, Rebecca A. Abernethy, Amy P. Clin Pharmacol Ther Development The role of real‐world evidence (RWE) in regulatory, drug development, and healthcare decision‐making is rapidly expanding. Recent advances have increased the complexity of cancer care and widened the gap between randomized clinical trial (RCT) results and the evidence needed for real‐world clinical decisions.1 Instead of remaining invisible, data from the >95% of cancer patients treated outside of clinical trials can help fill this void. John Wiley and Sons Inc. 2017-12-06 2018-02 /pmc/articles/PMC5814721/ /pubmed/29214638 http://dx.doi.org/10.1002/cpt.946 Text en © 2017 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 (http://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Development
Miksad, Rebecca A.
Abernethy, Amy P.
Harnessing the Power of Real‐World Evidence (RWE): A Checklist to Ensure Regulatory‐Grade Data Quality
title Harnessing the Power of Real‐World Evidence (RWE): A Checklist to Ensure Regulatory‐Grade Data Quality
title_full Harnessing the Power of Real‐World Evidence (RWE): A Checklist to Ensure Regulatory‐Grade Data Quality
title_fullStr Harnessing the Power of Real‐World Evidence (RWE): A Checklist to Ensure Regulatory‐Grade Data Quality
title_full_unstemmed Harnessing the Power of Real‐World Evidence (RWE): A Checklist to Ensure Regulatory‐Grade Data Quality
title_short Harnessing the Power of Real‐World Evidence (RWE): A Checklist to Ensure Regulatory‐Grade Data Quality
title_sort harnessing the power of real‐world evidence (rwe): a checklist to ensure regulatory‐grade data quality
topic Development
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5814721/
https://www.ncbi.nlm.nih.gov/pubmed/29214638
http://dx.doi.org/10.1002/cpt.946
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