The age of randomized clinical trials: three important aspects of randomized clinical trials in cardiovascular pharmacotherapy with examples from lipid, diabetes, and antithrombotic trials-Reference-Cited by-同舟云学术

The age of randomized clinical trials: three important aspects of randomized clinical trials in cardiovascular pharmacotherapy with examples from lipid, diabetes, and antithrombotic trials

Published:2020-11-02 Issue:5 Volume:7 Page:453-459
ISSN:2055-6837
Container-title:European Heart Journal - Cardiovascular Pharmacotherapy
language:en
Short-container-title:

Author:

Drexel Heinz¹²³^ORCID,Lewis Basil S⁴⁵,Rosano Giuseppe M C⁶,Saely Christoph H¹²⁷,Tautermann Gerda¹²⁷,Huber Kurt⁸⁹,Dopheide Joern F¹⁰,Kaski Juan Carlos¹¹,Mader Arthur¹²⁷,Niessner Alexander¹²,Savarese Gianluigi¹³,Schmidt Thomas A¹⁴,Semb AnneGrete¹⁵,Tamargo Juan¹⁶,Wassmann Sven¹⁷¹⁸,Per Kjeldsen Keld¹⁹²⁰,Agewall Stefan²¹²²^ORCID,Pocock Stuart J²³^ORCID

Affiliation:

1. Vorarlberg Institute for Vascular Investigation and Treatment (VIVIT), Carinagasse 47, Feldkirch 6800, Austria

2. Private University of the Principality of Liechtenstein, Dorfstr. 24, Triesen 9495, Liechtenstein

3. Drexel University College of Medicine, 2900 W Queen Lane, Philadelphia, PA 19129, USA

4. Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center, Michal Str. 7, 34362 Haifa, Israel

5. Ruth and Bruce Rappaport School of Medicine, Technion-Israel Institute of Technology, Efron Str. 1, 31096 Haifa, Israel

6. Department of Medical Sciences, IRCCS San Raffaele Hospital, Via delle Pisana 249, Rome 00163, Italy

7. Department of Medicine I, Academic Teaching Hospital Feldkirch, Carinagasse 47, Feldkirch 6800, Austria

8. 3rd Medical Department, Cardiology and Intensive Care Medicine, Wilhelminen Hospital, Montleartstr. 37, Vienna 1160, Austria

9. Medical School, Cardiology, Sigmund Freud University, Freudplatz 3, Vienna 1020, Austria

10. Division of Angiology, Swiss Cardiovascular Center, University Hospital Bern, Freiburgstr. 4, 3010 Bern, Switzerland

11. Molecular and Clinical Sciences Res. Inst, St George’s University of London, Cranmer Terrace, London SW17 0RE, UK

12. Department of Internal Medicine II, Medical University of Vienna, Währinger Gürtel 18-20, Vienna 1090, Austria

13. Cardiology Unit, Department of Medicine, Karolinska University Hospital D1:04, Stockholm 171 76, Sweden

14. Department of Emergency Medicine, North Zealand University Hospital, Dyrehavevey, Hillerød 3400, Denmark

15. Department of Rheumatology, Preventive Cardio-Rheuma Clinic, Diakonhjemmet Hospital, Diakonveien 12, Oslo 0370, Norway

16. Department of Pharmacology and Toxicology, School of Medicine, Universidad Complutense, CIBERCV, Plaza de Ramón s/n, Madrid 28040, Spain

17. Cardiology Pasing, Institutstr. 14, Munich 81241, Germany

18. Medical Faculty, Clinical Medicine, University of the Saarland, Kirrbergerstr. 100, Homburg/Saar 66421, Germany

19. Department of Cardiology, Copenhagen University Hospital (Amager-Hvidovre), Italiensvej 1, 2300 Copenhagen, Denmark

20. Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Fredrik Bajers Vej 7D2, 9220 Aalborg, Denmark

21. Department of Cardiology, Ullevål, Oslo University Hospital, Kirkeveien 166, Oslo 0450, Norway

22. Institute of Clinical Sciences, Søsterhjemmet, University of Oslo, Kirkeveien 166, Oslo 0450, Norway

23. Department of Medical Statistics, London School of Hygiene and Tropical Medicine, Keppel St, London WC1E 7HT, UK

Abstract

Abstract This review article aims to explain the important issues that data safety monitoring boards (DSMB) face when considering early termination of a trial and is specifically addressed to the needs of clinical and research cardiologists. We give an insight into the overall background and then focus on the three principal reasons for stopping trials, i.e. efficacy, futility, and harm. The statistical essentials are also addressed to familiarize clinicians with the key principles. The topic is further highlighted by numerous examples from lipid trials and antithrombotic trials. This is followed by an overview of regulatory aspects, including an insight into industry–investigator interactions. To conclude, we summarize the key elements that are the basis for a decision to stop a randomized clinical trial (RCT).

Publisher

Oxford University Press (OUP)

Subject

Pharmacology (medical),Cardiology and Cardiovascular Medicine

Link

http://academic.oup.com/ehjcvp/advance-article-pdf/doi/10.1093/ehjcvp/pvaa126/34602656/pvaa126.pdf

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