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Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation
Real‐world data and patient‐level data from completed randomized controlled trials are becoming available for secondary analysis on an unprecedented scale. A range of novel methodologies and study designs have been proposed for their analysis or combination. However, to make novel analytical methods...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7158212/ https://www.ncbi.nlm.nih.gov/pubmed/31574163 http://dx.doi.org/10.1002/cpt.1638 |
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author | Eichler, Hans‐Georg Koenig, Franz Arlett, Peter Enzmann, Harald Humphreys, Anthony Pétavy, Frank Schwarzer‐Daum, Brigitte Sepodes, Bruno Vamvakas, Spiros Rasi, Guido |
author_facet | Eichler, Hans‐Georg Koenig, Franz Arlett, Peter Enzmann, Harald Humphreys, Anthony Pétavy, Frank Schwarzer‐Daum, Brigitte Sepodes, Bruno Vamvakas, Spiros Rasi, Guido |
author_sort | Eichler, Hans‐Georg |
collection | PubMed |
description | Real‐world data and patient‐level data from completed randomized controlled trials are becoming available for secondary analysis on an unprecedented scale. A range of novel methodologies and study designs have been proposed for their analysis or combination. However, to make novel analytical methods acceptable for regulators and other decision makers will require their testing and validation in broadly the same way one would evaluate a new drug: prospectively, well‐controlled, and according to a pre‐agreed plan. From a European regulators' perspective, the established methods qualification advice procedure with active participation of patient groups and other decision makers is an efficient and transparent platform for the development and validation of novel study designs. |
format | Online Article Text |
id | pubmed-7158212 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-71582122020-04-20 Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation Eichler, Hans‐Georg Koenig, Franz Arlett, Peter Enzmann, Harald Humphreys, Anthony Pétavy, Frank Schwarzer‐Daum, Brigitte Sepodes, Bruno Vamvakas, Spiros Rasi, Guido Clin Pharmacol Ther Reviews Real‐world data and patient‐level data from completed randomized controlled trials are becoming available for secondary analysis on an unprecedented scale. A range of novel methodologies and study designs have been proposed for their analysis or combination. However, to make novel analytical methods acceptable for regulators and other decision makers will require their testing and validation in broadly the same way one would evaluate a new drug: prospectively, well‐controlled, and according to a pre‐agreed plan. From a European regulators' perspective, the established methods qualification advice procedure with active participation of patient groups and other decision makers is an efficient and transparent platform for the development and validation of novel study designs. John Wiley and Sons Inc. 2019-10-01 2020-04 /pmc/articles/PMC7158212/ /pubmed/31574163 http://dx.doi.org/10.1002/cpt.1638 Text en © 2019 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 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 | Reviews Eichler, Hans‐Georg Koenig, Franz Arlett, Peter Enzmann, Harald Humphreys, Anthony Pétavy, Frank Schwarzer‐Daum, Brigitte Sepodes, Bruno Vamvakas, Spiros Rasi, Guido Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation |
title | Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation |
title_full | Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation |
title_fullStr | Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation |
title_full_unstemmed | Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation |
title_short | Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation |
title_sort | are novel, nonrandomized analytic methods fit for decision making? the need for prospective, controlled, and transparent validation |
topic | Reviews |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7158212/ https://www.ncbi.nlm.nih.gov/pubmed/31574163 http://dx.doi.org/10.1002/cpt.1638 |
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