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).
Cardiovascular Agents
/ adverse effects
Cardiovascular Diseases
/ drug therapy
Cardiovascular System
/ drug effects
Case-Control Studies
Consensus
Decision Making
Health Care Costs
/ statistics & numerical data
Humans
Intention to Treat Analysis
/ statistics & numerical data
Medication Adherence
/ psychology
Physicians
/ organization & administration
Placebos
/ administration & dosage
Risk Assessment
Safety
Societies, Scientific
/ organization & administration
Spain
/ epidemiology
Treatment Outcome
United States
/ epidemiology
United States Food and Drug Administration
/ organization & administration
Adherence
Clinical trial
Compliance
Medication
Persistence
Journal
European heart journal
ISSN: 1522-9645
Titre abrégé: Eur Heart J
Pays: England
ID NLM: 8006263
Informations de publication
Date de publication:
01 07 2019
01 07 2019
Historique:
received:
12
02
2018
revised:
20
03
2018
accepted:
04
07
2018
pubmed:
12
7
2018
medline:
30
9
2020
entrez:
12
7
2018
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 29992264
pii: 5050879
doi: 10.1093/eurheartj/ehy377
pmc: PMC7963139
doi:
Substances chimiques
Cardiovascular Agents
0
Placebos
0
Types de publication
Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Webcast
Langues
eng
Sous-ensembles de citation
IM
Pagination
2070-2085Subventions
Organisme : NCATS NIH HHS
ID : UL1 TR000064
Pays : United States
Organisme : NHGRI NIH HHS
ID : U01 HG007269
Pays : United States
Commentaires et corrections
Type : ErratumIn
Type : ErratumIn
Informations de copyright
Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2018. For permissions, please email: journals.permissions@oup.com.
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