Improving Realism in Clinical Trial Simulations via Real‐World Data

Simulation validity depends on how well sampling distributions used reflect real‐patient characteristics, such as drug adherence, disease progression, and pharmacologic handling in the body. We challenge the current use of growth charts from nondisease‐specific pediatrics in simulations for drug dev...

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Detalles Bibliográficos
Autores principales: Kimko, Holly, Lee, Kwan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Perspective
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5702896/
https://www.ncbi.nlm.nih.gov/pubmed/28925064
http://dx.doi.org/10.1002/psp4.12232
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author Kimko, Holly
Lee, Kwan
author_facet Kimko, Holly
Lee, Kwan
author_sort Kimko, Holly
collection PubMed
description Simulation validity depends on how well sampling distributions used reflect real‐patient characteristics, such as drug adherence, disease progression, and pharmacologic handling in the body. We challenge the current use of growth charts from nondisease‐specific pediatrics in simulations for drug development. Complementary use of data from clinical trials and the real‐world is expected to achieve a more realistic representation of clinical outcomes for decisions in drug development, regulatory approval, and health technology assessment.
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spelling pubmed-57028962017-11-29 Improving Realism in Clinical Trial Simulations via Real‐World Data Kimko, Holly Lee, Kwan CPT Pharmacometrics Syst Pharmacol Perspective Simulation validity depends on how well sampling distributions used reflect real‐patient characteristics, such as drug adherence, disease progression, and pharmacologic handling in the body. We challenge the current use of growth charts from nondisease‐specific pediatrics in simulations for drug development. Complementary use of data from clinical trials and the real‐world is expected to achieve a more realistic representation of clinical outcomes for decisions in drug development, regulatory approval, and health technology assessment. John Wiley and Sons Inc. 2017-09-19 2017-11 /pmc/articles/PMC5702896/ /pubmed/28925064 http://dx.doi.org/10.1002/psp4.12232 Text en © 2017 The Authors CPT: Pharmacometrics & Systems Pharmacology 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 Perspective
Kimko, Holly
Lee, Kwan
Improving Realism in Clinical Trial Simulations via Real‐World Data
title Improving Realism in Clinical Trial Simulations via Real‐World Data
title_full Improving Realism in Clinical Trial Simulations via Real‐World Data
title_fullStr Improving Realism in Clinical Trial Simulations via Real‐World Data
title_full_unstemmed Improving Realism in Clinical Trial Simulations via Real‐World Data
title_short Improving Realism in Clinical Trial Simulations via Real‐World Data
title_sort improving realism in clinical trial simulations via real‐world data
topic Perspective
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5702896/
https://www.ncbi.nlm.nih.gov/pubmed/28925064
http://dx.doi.org/10.1002/psp4.12232
work_keys_str_mv AT kimkoholly improvingrealisminclinicaltrialsimulationsviarealworlddata
AT leekwan improvingrealisminclinicaltrialsimulationsviarealworlddata

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