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Standardized classification and framework for reporting, interpreting, and analysing medication non-adherence in cardiovascular clinical trials: a consensus report from the Non-adherence Academic Research Consortium (NARC).

Authors :
Valgimigli M
Garcia-Garcia HM
Vrijens B
Vranckx P
McFadden EP
Costa F
Pieper K
Vock DM
Zhang M
Van Es GA
Tricoci P
Baber U
Steg G
Montalescot G
Angiolillo DJ
Serruys PW
Farb A
Windecker S
Kastrati A
Colombo A
Feres F
Jüni P
Stone GW
Bhatt DL
Mehran R
Tijssen JGP
Source :
European heart journal [Eur Heart J] 2019 Jul 01; Vol. 40 (25), pp. 2070-2085.
Publication Year :
2019

Abstract

Non-adherence has been well recognized for years to be a common issue that significantly impacts clinical outcomes and health care costs. Medication adherence is remarkably low even in the controlled environment of clinical trials where it has potentially complex major implications. Collection of non-adherence data diverge markedly among cardiovascular randomized trials and, even where collected, is rarely incorporated in the statistical analysis to test the consistency of the primary endpoint(s). The imprecision introduced by the inconsistent assessment of non-adherence in clinical trials might confound the estimate of the calculated efficacy of the study drug. Hence, clinical trials may not accurately answer the scientific question posed by regulators, who seek an accurate estimate of the true efficacy and safety of treatment, or the question posed by payers, who want a reliable estimate of the effectiveness of treatment in the marketplace after approval. The Non-adherence Academic Research Consortium is a collaboration among leading academic research organizations, representatives from the U.S. Food and Drug Administration and physician-scientists from the USA and Europe. One in-person meeting was held in Madrid, Spain, culminating in a document describing consensus recommendations for reporting, collecting, and analysing adherence endpoints across clinical trials. The adoption of these recommendations will afford robustness and consistency in the comparative safety and effectiveness evaluation of investigational drugs from early development to post-marketing approval studies. These principles may be useful for regulatory assessment, as well as for monitoring local and regional outcomes to guide quality improvement initiatives.<br /> (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2018. For permissions, please email: journals.permissions@oup.com.)

Details

Language :
English
ISSN :
1522-9645
Volume :
40
Issue :
25
Database :
MEDLINE
Journal :
European heart journal
Publication Type :
Academic Journal
Accession number :
29992264
Full Text :
https://doi.org/10.1093/eurheartj/ehy377