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)

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 no...

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Bibliographic Details
Published in:European heart journal 2019-07, Vol.40 (25), p.2070-2085
Main Authors: Valgimigli, Marco, Garcia-Garcia, Hector M, Vrijens, Bernard, Vranckx, Pascal, McFadden, Eugène P, Costa, Francesco, Pieper, Karen, Vock, David M, Zhang, Min, Van Es, Gerrit-Anne, Tricoci, Pierluigi, Baber, Usman, Steg, Gabriel, Montalescot, Gilles, Angiolillo, Dominick J, Serruys, Patrick W, Farb, Andrew, Windecker, Stephan, Kastrati, Adnan, Colombo, Antonio, Feres, Fausto, Jüni, Peter, Stone, Gregg W, Bhatt, Deepak L, Mehran, Roxana, Tijssen, Jan G P
Format: Article
Language:English
Subjects:
Cardiovascular Agents - adverse effects
Cardiovascular Agents - economics
Cardiovascular Agents - therapeutic use
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
Life Sciences
Medication Adherence - psychology
Medication Adherence - statistics & numerical data
Physicians - organization & administration
Placebos - administration & dosage
Risk Assessment
Safety
Societies, Scientific - organization & administration
Spain - epidemiology
Special
Treatment Outcome
United States - epidemiology
United States Food and Drug Administration - organization & administration
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Summary: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.
ISSN:0195-668X
1522-9645
DOI:10.1093/eurheartj/ehy377