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Centre for Statistical and Methodological Excellence (CESAME): A Consortium Initiative for Improving Methodology in Randomised Clinical Trials
When conducting randomised clinical trials, the choice of methodology and statistical analyses will influence the results. If the planned methodology is not of optimal quality and predefined in detail, there is a risk of biased trial results and interpretation. Even though clinical trial methodology...
Autores principales: | , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
SAGE Publications
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10107963/ https://www.ncbi.nlm.nih.gov/pubmed/37077323 http://dx.doi.org/10.1177/11786329231166519 |
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author | Jørgensen, Caroline Kamp Olsen, Markus Harboe Nielsen, Niklas Lange, Theis Mbuagbaw, Lawrence Thabane, Lehana Billot, Laurent Binder, Nadine Garattini, Silvio Banzi, Rita Demotes, Jacques Biagioli, Elena Rulli, Eliana Bertolini, Guido Nattino, Giovanni Mathiesen, Ole Torri, Valter Gluud, Christian Jakobsen, Janus Christian |
author_facet | Jørgensen, Caroline Kamp Olsen, Markus Harboe Nielsen, Niklas Lange, Theis Mbuagbaw, Lawrence Thabane, Lehana Billot, Laurent Binder, Nadine Garattini, Silvio Banzi, Rita Demotes, Jacques Biagioli, Elena Rulli, Eliana Bertolini, Guido Nattino, Giovanni Mathiesen, Ole Torri, Valter Gluud, Christian Jakobsen, Janus Christian |
author_sort | Jørgensen, Caroline Kamp |
collection | PubMed |
description | When conducting randomised clinical trials, the choice of methodology and statistical analyses will influence the results. If the planned methodology is not of optimal quality and predefined in detail, there is a risk of biased trial results and interpretation. Even though clinical trial methodology is already at a very high standard, there are many trials that deliver biased results due to the implementation of inadequate methodology, poor data quality and erroneous or biased analyses. To increase the internal and external validity of randomised clinical trial results, several international institutions within clinical intervention research have formed The Centre for Statistical and Methodological Excellence (CESAME). Based on international consensus, the CESAME initiative will develop recommendations for the proper methodological planning, conduct and analysis of clinical intervention research. CESAME aims to increase the validity of randomised clinical trial results which will ultimately benefit patients worldwide across medical specialities. The work of CESAME will be performed within 3 closely interconnected pillars: (1) planning randomised clinical trials; (2) conducting randomised clinical trials; and (3) analysing randomised clinical trials. |
format | Online Article Text |
id | pubmed-10107963 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | SAGE Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-101079632023-04-18 Centre for Statistical and Methodological Excellence (CESAME): A Consortium Initiative for Improving Methodology in Randomised Clinical Trials Jørgensen, Caroline Kamp Olsen, Markus Harboe Nielsen, Niklas Lange, Theis Mbuagbaw, Lawrence Thabane, Lehana Billot, Laurent Binder, Nadine Garattini, Silvio Banzi, Rita Demotes, Jacques Biagioli, Elena Rulli, Eliana Bertolini, Guido Nattino, Giovanni Mathiesen, Ole Torri, Valter Gluud, Christian Jakobsen, Janus Christian Health Serv Insights Perspective When conducting randomised clinical trials, the choice of methodology and statistical analyses will influence the results. If the planned methodology is not of optimal quality and predefined in detail, there is a risk of biased trial results and interpretation. Even though clinical trial methodology is already at a very high standard, there are many trials that deliver biased results due to the implementation of inadequate methodology, poor data quality and erroneous or biased analyses. To increase the internal and external validity of randomised clinical trial results, several international institutions within clinical intervention research have formed The Centre for Statistical and Methodological Excellence (CESAME). Based on international consensus, the CESAME initiative will develop recommendations for the proper methodological planning, conduct and analysis of clinical intervention research. CESAME aims to increase the validity of randomised clinical trial results which will ultimately benefit patients worldwide across medical specialities. The work of CESAME will be performed within 3 closely interconnected pillars: (1) planning randomised clinical trials; (2) conducting randomised clinical trials; and (3) analysing randomised clinical trials. SAGE Publications 2023-04-11 /pmc/articles/PMC10107963/ /pubmed/37077323 http://dx.doi.org/10.1177/11786329231166519 Text en © The Author(s) 2023 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 Jørgensen, Caroline Kamp Olsen, Markus Harboe Nielsen, Niklas Lange, Theis Mbuagbaw, Lawrence Thabane, Lehana Billot, Laurent Binder, Nadine Garattini, Silvio Banzi, Rita Demotes, Jacques Biagioli, Elena Rulli, Eliana Bertolini, Guido Nattino, Giovanni Mathiesen, Ole Torri, Valter Gluud, Christian Jakobsen, Janus Christian Centre for Statistical and Methodological Excellence (CESAME): A Consortium Initiative for Improving Methodology in Randomised Clinical Trials |
title | Centre for Statistical and Methodological Excellence (CESAME): A
Consortium Initiative for Improving Methodology in Randomised Clinical
Trials |
title_full | Centre for Statistical and Methodological Excellence (CESAME): A
Consortium Initiative for Improving Methodology in Randomised Clinical
Trials |
title_fullStr | Centre for Statistical and Methodological Excellence (CESAME): A
Consortium Initiative for Improving Methodology in Randomised Clinical
Trials |
title_full_unstemmed | Centre for Statistical and Methodological Excellence (CESAME): A
Consortium Initiative for Improving Methodology in Randomised Clinical
Trials |
title_short | Centre for Statistical and Methodological Excellence (CESAME): A
Consortium Initiative for Improving Methodology in Randomised Clinical
Trials |
title_sort | centre for statistical and methodological excellence (cesame): a
consortium initiative for improving methodology in randomised clinical
trials |
topic | Perspective |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10107963/ https://www.ncbi.nlm.nih.gov/pubmed/37077323 http://dx.doi.org/10.1177/11786329231166519 |
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