Independent academic Data Monitoring Committees for clinical trials in cardiovascular and cardiometabolic diseases-Reference-Cited by-同舟云学术

Independent academic Data Monitoring Committees for clinical trials in cardiovascular and cardiometabolic diseases

Published:2017-03-08 Issue:4 Volume:19 Page:449-456
ISSN:1388-9842
Container-title:European Journal of Heart Failure
language:en
Short-container-title:Eur J Heart Fail

Author:

Filippatos Gerasimos S.¹,de Graeff Pieter²³,Bax Jeroen J.⁴,Borg John-Joseph⁵,Cleland John G.F.⁶,Dargie Henry J.⁷,Flather Marcus⁸,Ford Ian⁹,Friede Tim¹⁰¹¹,Greenberg Barry¹²,Henon-Goburdhun Cécile¹³,Holcomb Richard¹⁴,Horst Bradley¹⁵,Lekakis John¹,Mueller-Velten Guenther¹⁶,Papavassiliou Athanasios G.¹⁷¹⁸,Prasad Krishna¹⁹²⁰,Rosano Giuseppe M.C.²¹²²,Severin Thomas¹⁶,Sherman Warren²³,Stough Wendy Gattis²⁴,Swedberg Karl²⁵²⁶,Tavazzi Luigi²⁷,Tousoulis Dimitris²⁸,Vardas Panagiotis²⁹,Ruschitzka Frank³⁰,Anker Stefan D.³¹

Affiliation:

1. National and Kapodistrian University of Athens, School of Medicine; Athens University Hospital Attikon; Athens Greece

2. Department of Clinical Pharmacy and Pharmacology, University of Groningen; University Medical Centre Groningen; Groningen the Netherlands

3. Dutch Medicines Evaluation Board (CBG-MEB); Utrecht the Netherlands

4. Department of Cardiology; Leiden University Medical Centre; Leiden the Netherlands

5. Medicines Authority; Malta

6. National Heart and Lung Institute; Royal Brompton and Harefield Hospitals; Imperial College London UK

7. Cardiology Department; Western Infirmary; Glasgow Scotland UK

8. Norfolk and Norwich University Hospitals NHS Foundation Trust and Norwich Medical School; University of East Anglia; Norfolk UK

9. Robertson Centre for Biostatistics; University of Glasgow; Glasgow UK

10. Department of Medical Statistics; University Medical Centre Göttingen; Germany

11. DZHK (German Centre for Cardiovascular Research); partner site Göttingen Göttingen Germany

12. University of California at San Diego; CA USA

13. Servier; Suresnes France

14. Minneapolis; MN USA

15. Boston Scientific; St Paul MN USA

16. Novartis Pharma AG; Basel Switzerland

17. Department of Biological Chemistry, Medical School; National and Kapodistrian University of Athens; Athens Greece

18. National Ethics Committee for Clinical Trials; Athens Greece

19. UK Medicines and Healthcare Products Regulatory Agency; London UK

20. St Thomas' Hospital; London UK

21. IRCCS San Raffaele Hospital Roma; Rome Italy

22. Cardiovascular and Cell Sciences Institute; St George's University of London; London UK

23. LoneStar Heart; Irvine, CA USA

24. Campbell University College of Pharmacy and Health Sciences; Cary, NC USA

25. Sahlgrenska Academy; University of Gothenburg; Gothenburg Sweden

26. National Heart and Lung Institute; Imperial College; London UK

27. GVM Care and Research, ES Health Science Foundation; Maria Cecilia Hospital; Cotignola Italy

28. 1st Department of Cardiology; Hippokration Hospital; University of Athens Athens Greece

29. Department of Cardiology; Heraklion University Hospital; Crete Greece

30. Department of Cardiology, Heart Failure Clinic and Transplantation; University Heart Centre Zurich; Zurich Switzerland

31. Innovative Clinical Trials, Department of Cardiology and Pneumology; University Medical Centre Göttingen (UMG); Robert-Koch-Strasse 40 D-37075 Göttingen Germany

Funder

Heart Failure Society of America

University of North Carolina

Vifor Pharma

AstraZeneca

Biotronik

Publisher

Wiley

Subject

Cardiology and Cardiovascular Medicine

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/ejhf.761/fullpdf

Reference34 articles.

1. Data safety and monitoring boards;Slutsky;N Engl J Med,2004

2. European Medicines Agency Guideline on data monitoring committees http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003635.pdf 2016

3. US Department of Health and Human Services and 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 2016

4. Independent data monitoring committees: preparing a path for the future;Hess;Am Heart J,2014

5. A primer on data safety monitoring boards: mission, methods, and controversies;Hicks;Intensive Care Med,2007

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