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

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 drug...

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Bibliographic Details
Published inRecenti progressi in medicina Vol. 103; no. 3; p. 103
Main Authors Cherubini, Antonio, Cerenzia, Annarita, Zengarini, Elisa
Format Journal Article
LanguageItalian
Published Italy 01.03.2012
Subjects
Aged
Clinical Trials as Topic - ethics
Clinical Trials as Topic - standards
Heart Failure
Humans
Patient Selection - ethics
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Summary: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.
ISSN:0034-1193
DOI:10.1701/1046.11401