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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 LU ; Lange, Theis ; Mbuagbaw, Lawrence ; Thabane, Lehana ; Billot, Laurent ; Binder, Nadine ; Garattini, Silvio and Banzi, Rita , et al. (2023) In Health Services Insights 16.
Abstract

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... (More)

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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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
biostatistics, centre of excellence, consortium, methodology, Randomised clinical trials
in
Health Services Insights
volume
16
publisher
SAGE Publications
external identifiers
  • pmid:37077323
  • scopus:85153206128
ISSN
1178-6329
DOI
10.1177/11786329231166519
language
English
LU publication?
yes
id
dcd74b06-4930-4332-a942-068aeebb8cf4
date added to LUP
2023-07-14 11:42:57
date last changed
2024-04-19 23:29:38
@article{dcd74b06-4930-4332-a942-068aeebb8cf4,
  abstract     = {{<p>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.</p>}},
  author       = {{Jørgensen, Caroline Kamp and Olsen, Markus Harboe and Nielsen, Niklas and Lange, Theis and Mbuagbaw, Lawrence and Thabane, Lehana and Billot, Laurent and Binder, Nadine and Garattini, Silvio and Banzi, Rita and Demotes, Jacques and Biagioli, Elena and Rulli, Eliana and Bertolini, Guido and Nattino, Giovanni and Mathiesen, Ole and Torri, Valter and Gluud, Christian and Jakobsen, Janus Christian}},
  issn         = {{1178-6329}},
  keywords     = {{biostatistics; centre of excellence; consortium; methodology; Randomised clinical trials}},
  language     = {{eng}},
  publisher    = {{SAGE Publications}},
  series       = {{Health Services Insights}},
  title        = {{Centre for Statistical and Methodological Excellence (CESAME) : A Consortium Initiative for Improving Methodology in Randomised Clinical Trials}},
  url          = {{http://dx.doi.org/10.1177/11786329231166519}},
  doi          = {{10.1177/11786329231166519}},
  volume       = {{16}},
  year         = {{2023}},
}