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

Drexel, Heinz; Lewis, Basil S; Rosano, Giuseppe M C; Saely, Christoph H; Tautermann, Gerda; Huber, Kurt; Dopheide, Joern F.; Kaski, Juan Carlos; Mader, Arthur; Niessner, Alexander; Savarese, Gianluigi; Schmidt, Thomas A; Semb, AnneGrete; Tamargo, Juan; Wassmann, Sven; Kjeldsen, Keld Per; Agewall, Stefan; Pocock, Stuart J (2020). The age of randomized clinical trials: three important aspects of randomized clinical trials in cardiovascular pharmacotherapy with examples from lipid, diabetes, and antithrombotic trials. (In Press). European heart journal. Cardiovascular pharmacotherapy Oxford University Press 10.1093/ehjcvp/pvaa126

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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).

Item Type:

Journal Article (Review Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Angiology

UniBE Contributor:

Dopheide, Jörn

Subjects:

600 Technology > 610 Medicine & health

ISSN:

2055-6845

Publisher:

Oxford University Press

Language:

English

Submitter:

Rebecca Scheidegger

Date Deposited:

07 Jan 2021 10:23

Last Modified:

07 Apr 2021 08:24

Publisher DOI:

10.1093/ehjcvp/pvaa126

PubMed ID:

33135079

BORIS DOI:

10.48350/149865

URI:

https://boris.unibe.ch/id/eprint/149865

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