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

Marco Valgimigli, Hector M. Garcia-Garcia, Bernard Vrijens, Pascal Vranckx, Eugène P. McFadden, Francesco Costa, Karen Pieper, David M. Vock, Min Zhang, Gerrit Anne Van Es, Pierluigi Tricoci, Usman Baber, Gabriel Steg, Gilles Montalescot, Dominick J. Angiolillo, Patrick W. Serruys, Andrew Farb, Stephan Windecker, Adnan Kastrati, Antonio ColomboFausto Feres, Peter Jüni, Gregg W. Stone, Deepak L. Bhatt, Roxana Mehran, Jan G.P. Tijssen

Research output: Contribution to journalArticlepeer-review

60 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)2070-2085
Number of pages16
JournalEuropean heart journal
Volume40
Issue number25
DOIs
StatePublished - Jul 1 2019

Bibliographical note

Publisher Copyright:
© The Author(s) 2019.

Keywords

  • Adherence
  • Clinical trial
  • Compliance
  • Medication
  • Persistence

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