Reproducibility of clinical events adjudications in a trial of venous thromboembolism prevention-Reference-Cited by-同舟云学术

Reproducibility of clinical events adjudications in a trial of venous thromboembolism prevention

Published:2017-03-01 Issue:4 Volume:15 Page:662-669
ISSN:1538-7933
Container-title:Journal of Thrombosis and Haemostasis
language:en
Short-container-title:J Thromb Haemost

Author:

Girard P.¹,Penaloza A.²,Parent F.³,Gable B.⁴,Sanchez O.⁵,Durieux P.⁶,Hausfater P.⁷,Dambrine S.⁴,Meyer G.⁵,Roy P.-M.⁸

Affiliation:

1. Département Thoracique; L'Institut Mutualiste Montsouris; Paris France

2. Service des Urgences; Cliniques Universitaires St Luc; Université Catholique de Louvain; Brussels Belgium

3. Service de Pneumologie; Centre de Référence de l'Hypertension Pulmonaire Sévère; Hôpital de Bicêtre; AP-HP; Université Paris-Sud; INSERM UMRS 999; Le Kremlin Bicêtre France

4. Département de Médecine d'Urgence; CHU d'Angers; Angers France

5. Service de Pneumologie; Hôpital Européen Georges Pompidou; AP-HP; Université Paris Descartes; Sorbonne Paris Cité; INSERM UMRS 970 and CIC 1418; Paris France

6. Département de Santé Publique et Informatique Médicale; Hôpital Européen Georges Pompidou; AP-HP; Université Paris Descartes; Sorbonne Paris Cité; INSERM UMRS 872; Centre de recherche des Cordeliers; Paris France

7. Département des Urgences; Hôpital Pitié-Salpêtrière; AP-HP; Sorbonne Universités UPMC-Univ Paris 6; INSERM UMRS 1166; IHUC ICAN; GRC-UPMC BIOSFAST; Paris France

8. Département de Médecine d'Urgence; Centre Vasculaire et de la Coagulation; CHU d'Angers; Institut MITOVASC, EA3860; Université d'Angers; Angers France

Publisher

Wiley

Subject

Hematology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/jth.13626/fullpdf

Reference20 articles.

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2. Food and Drug Administration Guidance for clinical trial sponsors. Establishment and Operation of Clinical Trial Data Monitoring Committees http://www.fda.gov/downloads/Regulatoryinformation/Guidances/ucm127073.pdf

3. Inadequate planning and reporting of adjudication committees in clinical trials: recommendation proposal;Dechartres;J Clin Epidemiol,2009

4. Adjudication of bleeding outcomes in an international thromboprophylaxis trial in critical illness;Arnold;Thromb Res,2013

5. Disagreements between central clinical events committee and site investigator assessments of myocardial infarction endpoints in an international clinical trial: review of the PURSUIT study;Mahaffey;Curr Control Trials Cardiovasc Med,2001

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