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). - 2019

Available online from MWHC library: 1996 - present (after 1 year), Available in print through MWHC library: 1999 - 2006

Copyright Published on behalf of the European Society of Cardiology. All rights reserved. (c) The Author(s) 2018. For permissions, please email: journals.permissions@oup.com. 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.


English

0195-668X

10.1093/eurheartj/ehy377 [doi] 5050879 [pii]


*Cardiovascular Agents/tu [Therapeutic Use]
*Cardiovascular Diseases/dt [Drug Therapy]
*Cardiovascular System/de [Drug Effects]
*Health Care Costs/sn [Statistics & Numerical Data]
*Medication Adherence/sn [Statistics & Numerical Data]
Cardiovascular Agents/ae [Adverse Effects]
Cardiovascular Agents/ec [Economics]
Case-Control Studies
Consensus
Decision Making
Humans
Intention to Treat Analysis/sn [Statistics & Numerical Data]
Medication Adherence/px [Psychology]
Physicians/og [Organization & Administration]
Placebos/ad [Administration & Dosage]
Risk Assessment
Safety
Societies, Scientific/og [Organization & Administration]
Spain/ep [Epidemiology]
Treatment Outcome
United States Food and Drug Administration/og [Organization & Administration]
United States/ep [Epidemiology]


MedStar Heart & Vascular Institute


Journal Article