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)
Year: 2018
Type: article
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.
Source: European Heart Journal
Authors: 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 Colombo, Fausto Feres, Peter Jüni, Gregg W Stone, Deepak L Bhatt, Roxana Mehran, Jan G P Tijssen
Institutions: University Hospital of Bern, MedStar Washington Hospital Center, University of Liège, Jessa Hospital, Hartcentrum Hasselt, Hasselt University, Cork University Hospital, University of Messina, Azienda Ospedaliera Universitaria Policlinico "G. Martino", Duke Medical Center, Duke Clinical Research Institute, University of Minnesota, University of Michigan, European Cardiovascular Research Institute, Icahn School of Medicine at Mount Sinai, Assistance Publique – Hôpitaux de Paris, Hôpital Bichat-Claude-Bernard, Pitié-Salpêtrière Hospital, University of Florida, Imperial College London, United States Food and Drug Administration, Center for Drug Evaluation and Research, Deutsches Herzzentrum München, Technical University of Munich, EMO GVM Centro Cuore Columbus, IRCCS Ospedale San Raffaele, Instituto Dante Pazzanese de Cardiologia, NewYork–Presbyterian Hospital, Columbia University Irving Medical Center, Cardiovascular Research Foundation, Brigham and Women's Hospital, Harvard University, Amsterdam UMC Location University of Amsterdam, University of Amsterdam
Language: English
Subfield: Family Practice
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Funders: American Heart Association, Abbott Laboratories, Amgen, Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, AstraZeneca, Sanofi, Gilead Sciences, Cleveland Clinic, CSL Behring, Boston Scientific Corporation, Boston VA Research Institute, Exelixis, Ironwood Pharmaceuticals, Incorporated, Ablynx, Amarin Corporation, Medicines Company, Osprey Medical, Regado Biosciences, Belvoir Media Group, Eisai, National Institutes of Health, St. Jude Medical, Abbott Vascular, TherOx, National Human Genome Research Institute, National Center for Advancing Translational Sciences, Duke Clinical Research Institute, Janssen Pharmaceuticals
OpenAlex ID: W2846895012