The persistent exclusion of older patients from ongoing clinical trials regarding heart failure

Antonio Cherubini, Joaquim Oristrell, Xavier Pla, Carmelinda Ruggiero, Roberta Ferretti, Germán Diestre, A. Mark Clarfield, Peter Crome, Cees Hertogh, Vita Lesauskaite, Gabriel Ioan Prada, Katarzyna Szczerbinska, Eva Topinkova, Judith Sinclair-Cohen, David Edbrooke, Gary H. Mills

Research output: Contribution to journalArticle

181 Citations (Scopus)

Abstract

Background: Much clinical research of relevance to elderly patients examines individuals who are younger than those who have the disease in question. A good example is heart failure. Therefore, we investigated the extent of exclusion of older individuals in ongoing clinical trials regarding heart failure. Methods: In the context of the Increasing the PaRticipation of the ElDerly in Clinical Trials (PREDICT) study, data from ongoing clinical trials regarding heart failure were extracted from the World Health Organization Clinical Trials Registry Platform on December 1, 2008. Main outcome measures were the proportion of trials excluding patients by an arbitrary upper age limit or by other exclusion criteria that might indirectly cause limited recruitment of older individuals. We classified exclusion criteria into 2 categories: justified or poorly justified. Results: Among 251 trials investigating treatments for heart failure, 64 (25.5%) excluded patients by an arbitrary upper age limit. Such exclusion was significantly more common in trials conducted in the European Union than in the United States (31/96 [32.3%] vs 17/105 [16.2%]; P=.007) and in drug trials sponsored by public institutions vs those by private entities (21/59 [35.6%] vs 5/36 [13.9%]; P=.02). Overall, 109 trials (43.4%) on heart failure had 1 or more poorly justified exclusion criteria that could limit the inclusion of older individuals. A similar proportion of clinical trials with poorly justified exclusion criteria was found in pharmacologic and nonpharmacologic trials. Conclusion: Despite the recommendations of national and international regulatory agencies, exclusion of older individuals from ongoing trials regarding heart failure continues to be widespread.

Original languageEnglish
Pages (from-to)550-556
Number of pages7
JournalArchives of Internal Medicine
Volume171
Issue number6
DOIs
Publication statusPublished - Mar 28 2011

Fingerprint

Heart Failure
Clinical Trials
International Agencies
European Union
Treatment Failure
Registries
Outcome Assessment (Health Care)
Research
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Internal Medicine

Cite this

The persistent exclusion of older patients from ongoing clinical trials regarding heart failure. / Cherubini, Antonio; Oristrell, Joaquim; Pla, Xavier; Ruggiero, Carmelinda; Ferretti, Roberta; Diestre, Germán; Clarfield, A. Mark; Crome, Peter; Hertogh, Cees; Lesauskaite, Vita; Prada, Gabriel Ioan; Szczerbinska, Katarzyna; Topinkova, Eva; Sinclair-Cohen, Judith; Edbrooke, David; Mills, Gary H.

In: Archives of Internal Medicine, Vol. 171, No. 6, 28.03.2011, p. 550-556.

Research output: Contribution to journalArticle

Cherubini, A, Oristrell, J, Pla, X, Ruggiero, C, Ferretti, R, Diestre, G, Clarfield, AM, Crome, P, Hertogh, C, Lesauskaite, V, Prada, GI, Szczerbinska, K, Topinkova, E, Sinclair-Cohen, J, Edbrooke, D & Mills, GH 2011, 'The persistent exclusion of older patients from ongoing clinical trials regarding heart failure', Archives of Internal Medicine, vol. 171, no. 6, pp. 550-556. https://doi.org/10.1001/archinternmed.2011.31
Cherubini, Antonio ; Oristrell, Joaquim ; Pla, Xavier ; Ruggiero, Carmelinda ; Ferretti, Roberta ; Diestre, Germán ; Clarfield, A. Mark ; Crome, Peter ; Hertogh, Cees ; Lesauskaite, Vita ; Prada, Gabriel Ioan ; Szczerbinska, Katarzyna ; Topinkova, Eva ; Sinclair-Cohen, Judith ; Edbrooke, David ; Mills, Gary H. / The persistent exclusion of older patients from ongoing clinical trials regarding heart failure. In: Archives of Internal Medicine. 2011 ; Vol. 171, No. 6. pp. 550-556.
@article{33b89296ebe842d38f0d409516574c09,
title = "The persistent exclusion of older patients from ongoing clinical trials regarding heart failure",
abstract = "Background: Much clinical research of relevance to elderly patients examines individuals who are younger than those who have the disease in question. A good example is heart failure. Therefore, we investigated the extent of exclusion of older individuals in ongoing clinical trials regarding heart failure. Methods: In the context of the Increasing the PaRticipation of the ElDerly in Clinical Trials (PREDICT) study, data from ongoing clinical trials regarding heart failure were extracted from the World Health Organization Clinical Trials Registry Platform on December 1, 2008. Main outcome measures were the proportion of trials excluding patients by an arbitrary upper age limit or by other exclusion criteria that might indirectly cause limited recruitment of older individuals. We classified exclusion criteria into 2 categories: justified or poorly justified. Results: Among 251 trials investigating treatments for heart failure, 64 (25.5{\%}) excluded patients by an arbitrary upper age limit. Such exclusion was significantly more common in trials conducted in the European Union than in the United States (31/96 [32.3{\%}] vs 17/105 [16.2{\%}]; P=.007) and in drug trials sponsored by public institutions vs those by private entities (21/59 [35.6{\%}] vs 5/36 [13.9{\%}]; P=.02). Overall, 109 trials (43.4{\%}) on heart failure had 1 or more poorly justified exclusion criteria that could limit the inclusion of older individuals. A similar proportion of clinical trials with poorly justified exclusion criteria was found in pharmacologic and nonpharmacologic trials. Conclusion: Despite the recommendations of national and international regulatory agencies, exclusion of older individuals from ongoing trials regarding heart failure continues to be widespread.",
author = "Antonio Cherubini and Joaquim Oristrell and Xavier Pla and Carmelinda Ruggiero and Roberta Ferretti and Germ{\'a}n Diestre and Clarfield, {A. Mark} and Peter Crome and Cees Hertogh and Vita Lesauskaite and Prada, {Gabriel Ioan} and Katarzyna Szczerbinska and Eva Topinkova and Judith Sinclair-Cohen and David Edbrooke and Mills, {Gary H.}",
year = "2011",
month = "3",
day = "28",
doi = "10.1001/archinternmed.2011.31",
language = "English",
volume = "171",
pages = "550--556",
journal = "Archives of Internal Medicine",
issn = "0003-9926",
publisher = "American Medical Association",
number = "6",

}

TY - JOUR

T1 - The persistent exclusion of older patients from ongoing clinical trials regarding heart failure

AU - Cherubini, Antonio

AU - Oristrell, Joaquim

AU - Pla, Xavier

AU - Ruggiero, Carmelinda

AU - Ferretti, Roberta

AU - Diestre, Germán

AU - Clarfield, A. Mark

AU - Crome, Peter

AU - Hertogh, Cees

AU - Lesauskaite, Vita

AU - Prada, Gabriel Ioan

AU - Szczerbinska, Katarzyna

AU - Topinkova, Eva

AU - Sinclair-Cohen, Judith

AU - Edbrooke, David

AU - Mills, Gary H.

PY - 2011/3/28

Y1 - 2011/3/28

N2 - Background: Much clinical research of relevance to elderly patients examines individuals who are younger than those who have the disease in question. A good example is heart failure. Therefore, we investigated the extent of exclusion of older individuals in ongoing clinical trials regarding heart failure. Methods: In the context of the Increasing the PaRticipation of the ElDerly in Clinical Trials (PREDICT) study, data from ongoing clinical trials regarding heart failure were extracted from the World Health Organization Clinical Trials Registry Platform on December 1, 2008. Main outcome measures were the proportion of trials excluding patients by an arbitrary upper age limit or by other exclusion criteria that might indirectly cause limited recruitment of older individuals. We classified exclusion criteria into 2 categories: justified or poorly justified. Results: Among 251 trials investigating treatments for heart failure, 64 (25.5%) excluded patients by an arbitrary upper age limit. Such exclusion was significantly more common in trials conducted in the European Union than in the United States (31/96 [32.3%] vs 17/105 [16.2%]; P=.007) and in drug trials sponsored by public institutions vs those by private entities (21/59 [35.6%] vs 5/36 [13.9%]; P=.02). Overall, 109 trials (43.4%) on heart failure had 1 or more poorly justified exclusion criteria that could limit the inclusion of older individuals. A similar proportion of clinical trials with poorly justified exclusion criteria was found in pharmacologic and nonpharmacologic trials. Conclusion: Despite the recommendations of national and international regulatory agencies, exclusion of older individuals from ongoing trials regarding heart failure continues to be widespread.

AB - Background: Much clinical research of relevance to elderly patients examines individuals who are younger than those who have the disease in question. A good example is heart failure. Therefore, we investigated the extent of exclusion of older individuals in ongoing clinical trials regarding heart failure. Methods: In the context of the Increasing the PaRticipation of the ElDerly in Clinical Trials (PREDICT) study, data from ongoing clinical trials regarding heart failure were extracted from the World Health Organization Clinical Trials Registry Platform on December 1, 2008. Main outcome measures were the proportion of trials excluding patients by an arbitrary upper age limit or by other exclusion criteria that might indirectly cause limited recruitment of older individuals. We classified exclusion criteria into 2 categories: justified or poorly justified. Results: Among 251 trials investigating treatments for heart failure, 64 (25.5%) excluded patients by an arbitrary upper age limit. Such exclusion was significantly more common in trials conducted in the European Union than in the United States (31/96 [32.3%] vs 17/105 [16.2%]; P=.007) and in drug trials sponsored by public institutions vs those by private entities (21/59 [35.6%] vs 5/36 [13.9%]; P=.02). Overall, 109 trials (43.4%) on heart failure had 1 or more poorly justified exclusion criteria that could limit the inclusion of older individuals. A similar proportion of clinical trials with poorly justified exclusion criteria was found in pharmacologic and nonpharmacologic trials. Conclusion: Despite the recommendations of national and international regulatory agencies, exclusion of older individuals from ongoing trials regarding heart failure continues to be widespread.

UR - http://www.scopus.com/inward/record.url?scp=79955162230&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79955162230&partnerID=8YFLogxK

U2 - 10.1001/archinternmed.2011.31

DO - 10.1001/archinternmed.2011.31

M3 - Article

C2 - 21444844

AN - SCOPUS:79955162230

VL - 171

SP - 550

EP - 556

JO - Archives of Internal Medicine

JF - Archives of Internal Medicine

SN - 0003-9926

IS - 6

ER -