TY - JOUR

T1 - Centre for Statistical and Methodological Excellence (CESAME)

T2 - A Consortium Initiative for Improving Methodology in Randomised Clinical Trials

AU - Jørgensen, Caroline Kamp

AU - Olsen, Markus Harboe

AU - Nielsen, Niklas

AU - Lange, Theis

AU - Mbuagbaw, Lawrence

AU - Thabane, Lehana

AU - Billot, Laurent

AU - Binder, Nadine

AU - Garattini, Silvio

AU - Banzi, Rita

AU - Demotes, Jacques

AU - Biagioli, Elena

AU - Rulli, Eliana

AU - Bertolini, Guido

AU - Nattino, Giovanni

AU - Mathiesen, Ole

AU - Torri, Valter

AU - Gluud, Christian

AU - Jakobsen, Janus Christian

N1 - Publisher Copyright: © The Author(s) 2023.

PY - 2023

Y1 - 2023

N2 - 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.

AB - 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.

KW - biostatistics

KW - centre of excellence

KW - consortium

KW - methodology

KW - Randomised clinical trials

U2 - 10.1177/11786329231166519

DO - 10.1177/11786329231166519

M3 - Journal article

C2 - 37077323

AN - SCOPUS:85153206128

VL - 16

JO - Health Services Insights

JF - Health Services Insights

SN - 1178-6329

ER -