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. 2021 Sep 21;7(5):453-459. doi: 10.1093/ehjcvp/pvaa126.

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).

Keywords: Antithrombotic therapy; Cardiovascular disease; Cardiovascular pharmacotherapy; Diabetes; Lipids; Randomized clinical trials.

Publication types

  • Review

MeSH terms

  • Diabetes Mellitus* / diagnosis
  • Diabetes Mellitus* / drug therapy
  • Fibrinolytic Agents* / adverse effects
  • Humans
  • Lipids
  • Randomized Controlled Trials as Topic
  • Research Design

Substances

  • Fibrinolytic Agents
  • Lipids