Subgroup analyses in randomized clinical trials: value and limitations. Review #3 on important aspects of randomized clinical trials in cardiovascular pharmacotherapy

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  • Heinz Drexel
  • Stuart J. Pocock
  • Basil S. Lewis
  • Christoph H. Saely
  • Juan Carlos Kaski
  • Giuseppe M.C. Rosano
  • Gerda Tautermann
  • Kurt Huber
  • Joern F. Dopheide
  • Arthur Mader
  • Alexander Niessner
  • Gianluigi Savarese
  • Schmidt, Thomas Andersen
  • Anne Grete Semb
  • Juan Tamargo
  • Sven Wassmann
  • Martin Clodi
  • Keld Per Kjeldsen
  • Stefan Agewall
Two review articles previously published from our working group were dedicated to the selection of endpoints as well as to reasons for premature stopping of randomized clinical trials (RCTs).1,2 We there first discussed the importance of mortality and morbidity endpoints vs. softer endpoints like revascularization rates and the issue of endpoint adjudication. Second, we have shed light on the statistical methods and requirements to stop RCTs prematurely due to safety, futility, or overwhelming efficacy (vs. the control arm).

The main objective of this article is now to provide the clinical cardiologist with information how to judge and interpret published subgroup analyses. The next section will summarize the situation regarding subgroup analysis and put the current article in context.
TidsskriftEuropean Heart Journal - Cardiovascular Pharmacotherapy
Udgave nummer3
Sider (fra-til)302-310
Antal sider9
StatusUdgivet - 2022

ID: 313707849