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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...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2023
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.
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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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