[The exclusion of older patients from clinical trials regarding heart failure. Causes and consequences]

Recenti Prog Med. 2012 Mar;103(3):103-8. doi: 10.1701/1046.11401.
[Article in Italian]

Abstract

Older subjects are commonly excluded from clinical trials, that are the gold standard to assess the efficacy and safety of new drugs and non pharmacological therapies. The consequence is the lack of evidence about the optimal drug therapy in this population, who makes the highest consumption of drugs, with increased risk of adverse reactions and undertreatment. A clear example is heart failure: data obtained in the context of the European Project PREDICT confirm a widespread exclusion of older individuals from ongoing clinical trials in heart failure, despite the recommendations of regulatory agencies.

Publication types

  • Editorial
  • English Abstract

MeSH terms

  • Aged
  • Clinical Trials as Topic / ethics*
  • Clinical Trials as Topic / standards*
  • Heart Failure*
  • Humans
  • Patient Selection / ethics*