Zobrazeno 1 - 6
of 6
pro vyhledávání: '"Erik Doffagne"'
Autor:
Junichi Sakamoto, Akira Tsuburaya, Lieven Desmet, Kazuhiro Yoshida, Marc Buyse, Satoshi Morita, Tomasz Burzykowski, Koji Oba, Laura Trotta, Yuusuke Kabeya, Paurush Praveen, David Venet, Erik Doffagne, Yumi Miyashita
Publikováno v:
Clinical Trials. 16:512-522
Background/Aims A risk-based approach to clinical research may include a central statistical assessment of data quality. We investigated the operating characteristics of unsupervised statistical monitoring aimed at detecting atypical data in multicen
Autor:
Erik Doffagne, Catherine Timmermans, Catherine Legrand, Marc Buyse, Tomasz Burzykowski, David Venet, Lieven Desmet
Publikováno v:
Statistics in Biopharmaceutical Research. 9:1-11
As part of central statistical monitoring of multicenter clinical trial data, we propose a procedure based on the beta-binomial distribution for the detection of centers with atypical values for the probability of some event. The procedure makes no a
Autor:
David Venet, Marc Buyse, Catherine Timmermans, Erik Doffagne, Tomasz Burzykowski, Lieven Desmet, Catherine Legrand
Publikováno v:
Gastric Cancer, Vol. 19, no. 1, p. 24-30 (2016)
Data quality may impact the outcome of clinical trials; hence, there is a need to implement quality control strategies for the data collected. Traditional approaches to quality control have primarily used source data verification during on-site monit
Autor:
Catherine Timmermans, Catherine Legrand, Erik Doffagne, Marc Buyse, David Venet, Lieven Desmet, Tomasz Burzykowski
Publikováno v:
Statistics in Medicine, Vol. 33, no. 30, p. 5265-5279 (2014)
Multicenter studies are widely used to meet accrual targets in clinical trials. Clinical data monitoring is required to ensure the quality and validity of the data gathered across centers. One approach to this end is central statistical monitoring, w
Autor:
Pierre Goffette, Erik Doffagne, Jan Lerut, Christine Sempoux, Francine Roggen, Olga Ciccarelli, Raymond Reding, Patrice Finet, Quirino Lai, Chantal De Reyck
Publikováno v:
Transplant International. 25:867-875
Liver transplantation (LT) is a validated treatment for selected cirrhotics with hepatocellular cancer (HCC). A retrospective single center study including 137 recipients having proven HCC was done to refine inclusion criteria for LT as well as to lo
Autor:
Catherine Legrand, Erik Doffagne, Yves Tellier, Valerie Bee, Tomasz Burzykowski, Ursula Becker, François Beckers, Eric Genevois-Marlin, Veronique Wilson, Marc Buyse, David Venet
Publikováno v:
Clinical trials (London, England), Vol. 9, no. 6, p. 705-713 (2012)
Background Classical monitoring approaches rely on extensive on-site visits and source data verification. These activities are associated with high cost and a limited contribution to data quality. Central statistical monitoring is of particular inter