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)
Eur. Heart J. Cardiovasc. Pharmacother
; 40(25)Jul. 2019. ilus
Artigo
em Inglês
| Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP
| ID: biblio-1009597
Biblioteca responsável:
BR79.1
Localização: BR79.1
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.(AU)
Texto completo:
Disponível
Coleções:
Bases de dados nacionais
/
Brasil
Base de dados:
Sec. Est. Saúde SP
/
SESSP-IDPCPROD
Assunto principal:
Adesão à Medicação
Tipo de estudo:
Ensaio clínico controlado
/
Guia de prática clínica
Idioma:
Inglês
Revista:
Eur. Heart J. Cardiovasc. Pharmacother
Ano de publicação:
2019
Tipo de documento:
Artigo
Instituição/País de afiliação:
Bern University Hospital/CH
/
Bichat Hospital/FR
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Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School/US
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Centre Hospitalier Universitaire Pitie-Salpetriere/FR
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New York-Presbyterian Hospital and the Cardiovascular Research Foundation+US
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Cork University Hospital/IE
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Department of Cardiology/CH
/
Duke University Medical Center/US
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European Cardiovascular Research Institute/NL
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Food and Drug Administration/US