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Centre for Statistical and Methodological Excellence (CESAME) : A Consortium Initiative for Improving Methodology in Randomised Clinical Trials

Jørgensen, Caroline Kamp (author)
Copenhagen University Hospital,University of Southern Denmark
Olsen, Markus Harboe (author)
Copenhagen University Hospital
Nielsen, Niklas (author)
Lund University,Lunds universitet,Anestesiologi och intensivvård,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Kliniska Vetenskaper, Helsingborg,Institutionen för kliniska vetenskaper, Lund,Centrum för hjärtstopp,Forskargrupper vid Lunds universitet,SEBRA Sepsis and Bacterial Resistance Alliance,Anesthesiology and Intensive Care,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Clinical Sciences, Helsingborg,Department of Clinical Sciences, Lund,Center for cardiac arrest,Lund University Research Groups
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Lange, Theis (author)
University of Copenhagen
Mbuagbaw, Lawrence (author)
St Joseph’s Healthcare Hamilton,McMaster University
Thabane, Lehana (author)
McMaster University,St Joseph’s Healthcare Hamilton,University of Johannesburg
Billot, Laurent (author)
University of New South Wales
Binder, Nadine (author)
University Medical Center Freiburg
Garattini, Silvio (author)
Mario Negri Institute for Pharmacological Research
Banzi, Rita (author)
Mario Negri Institute for Pharmacological Research
Demotes, Jacques (author)
Biagioli, Elena (author)
Mario Negri Institute for Pharmacological Research
Rulli, Eliana (author)
Mario Negri Institute for Pharmacological Research
Bertolini, Guido (author)
Mario Negri Institute for Pharmacological Research
Nattino, Giovanni (author)
Mario Negri Institute for Pharmacological Research
Mathiesen, Ole (author)
University of Copenhagen,Zealand University Hospital
Torri, Valter (author)
Mario Negri Institute for Pharmacological Research
Gluud, Christian (author)
Copenhagen University Hospital,University of Southern Denmark
Jakobsen, Janus Christian (author)
Copenhagen University Hospital,University of Southern Denmark
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 (creator_code:org_t)
2023
2023
English.
In: Health Services Insights. - 1178-6329. ; 16
  • Journal article (peer-reviewed)
Abstract Subject headings
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  • 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.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Hälsovetenskap -- Annan hälsovetenskap (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Health Sciences -- Other Health Sciences (hsv//eng)

Keyword

biostatistics
centre of excellence
consortium
methodology
Randomised clinical trials

Publication and Content Type

art (subject category)
ref (subject category)

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