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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, H; Lewis, BS; Rosano, GMC; Saely, CH; Tautermann, G; Huber, K; Dopheide, JF; Kaski, JC; Mader, A; Niessner, A; et al. Drexel, H; Lewis, BS; Rosano, GMC; Saely, CH; Tautermann, G; Huber, K; Dopheide, JF; Kaski, JC; Mader, A; Niessner, A; Savarese, G; Schmidt, TA; Semb, A; Tamargo, J; Wassmann, S; Kjeldsen, KP; Agewall, S; Pocock, SJ (2021) The age of randomized clinical trials: three important aspects of randomized clinical trials in cardiovascular pharmacotherapy with examples from lipid, diabetes, and antithrombotic trials. Eur Heart J Cardiovasc Pharmacother, 7 (5). pp. 453-459. ISSN 2055-6845 https://doi.org/10.1093/ehjcvp/pvaa126
SGUL Authors: Rosano, Giuseppe Massimo Claudio

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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).

Item Type: Article
Additional Information: This is a pre-copyedited, author-produced version of an article accepted for publication in European Heart Journal - Cardiovascular Pharmacotherapy following peer review. The version of record Heinz Drexel, Basil S Lewis, Giuseppe M C Rosano, Christoph H Saely, Gerda Tautermann, Kurt Huber, Joern F Dopheide, Juan Carlos Kaski, Arthur Mader, Alexander Niessner, Gianluigi Savarese, Thomas A Schmidt, AnneGrete Semb, Juan Tamargo, Sven Wassmann, Keld Per Kjeldsen, Stefan Agewall, Stuart J Pocock, The age of randomized clinical trials: three important aspects of randomized clinical trials in cardiovascular pharmacotherapy with examples from lipid, diabetes, and antithrombotic trials, European Heart Journal - Cardiovascular Pharmacotherapy, Volume 7, Issue 5, September 2021, Pages 453–459 is available online at: https://doi.org/10.1093/ehjcvp/pvaa126
SGUL Research Institute / Research Centre: Academic Structure > Molecular and Clinical Sciences Research Institute (MCS)
Journal or Publication Title: Eur Heart J Cardiovasc Pharmacother
ISSN: 2055-6845
Language: eng
Dates:
DateEvent
September 2021Published
2 November 2020Published Online
15 October 2020Accepted
Publisher License: Publisher's own licence
PubMed ID: 33135079
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/112593
Publisher's version: https://doi.org/10.1093/ehjcvp/pvaa126

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