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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
Journal article   Open access   Peer reviewed

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

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, …
European heart journal. Cardiovascular pharmacotherapy, v 7(5), pp 453-459
21 Sep 2021
DOI: https://doi.org/10.1093/ehjcvp/pvaa126
url
https://vbn.aau.dk/da/publications/472d1ea9-0994-4e1e-94fd-90e6f9ec9d56View
Published, Version of Record (VoR)Open Access (License Unspecified),  Open
url
https://doi.org/10.1093/ehjcvp/pvaa126View
Published, Version of Record (VoR) Open

Abstract

Cardiac & Cardiovascular Systems Cardiovascular System & Cardiology Life Sciences & Biomedicine Pharmacology & Pharmacy Science & Technology
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).

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