Linear mixed-effects models for central statistical monitoring of multicenter clinical trials-Reference-Cited by-同舟云学术

Linear mixed-effects models for central statistical monitoring of multicenter clinical trials

Published:2014-09-12 Issue:30 Volume:33 Page:5265-5279
ISSN:0277-6715
Container-title:Statistics in Medicine
language:en
Short-container-title:Statist. Med.

Author:

Desmet L.¹,Venet D.²,Doffagne E.³,Timmermans C.³,Burzykowski T.³⁴,Legrand C.¹,Buyse M.⁴⁵

Affiliation:

1. Institut de Statistique, Biostatistique et Sciences Actuarielles (ISBA); Université catholique de Louvain; Louvain-la-Neuve Belgium

2. Institut de Recherches Interdisciplinaires et de Développements en Intelligence Artificielle (IRIDIA); Université Libre de Bruxelles; Brussels Belgium

3. International Drug Development Institute (IDDI) S.A.; Louvain-la-Neuve Belgium

4. Interuniversity Institute for Biostatistics and statistical Bioinformatics (I-BioStat); Hasselt University; Diepenbeek Belgium

5. International Drug Development Institute (IDDI) Inc.; San Francisco CA U.S.A.

Funder

Federaal Wetenschapsbeleid

RÃ©gion Wallonne

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Reference10 articles.

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3. Guidance for industry: oversight of clinical investigations - a risk-based approach to monitoring : Silver Spring, MD 2014

4. Reflection paper on risk based quality management in clinical trials. EMA/INS/GCP/394194/2011 European Medicines Agency London, UK 2011

5. A statistical approach to central monitoring of data quality in clinical trials;Venet;Clinical Trials,2012

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