DEC-2018 : Electronic compilation of drug dosing history data using MEMS® combined with the medAmigo® software suite facilitates greatly the implementation of NARC in clinical trials.
The NARC classification is based on the duration of the pharmacological effect of the study drug and relies on individual dosing history data to stratify patients’ adherence to medications during the course of clinical trials.
The Academic Research Consortium (ARC) 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.
Given the high prevalence of non-adherence even in the controlled environment of clinical trials, the consortium has proposed a continuous, hierarchical and standardized classification and framework for reporting medication non-adherence (NARC) in clinical trials.
The NARC paper describes 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.
Eur Heart J. 2018 Jul 9.
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).
Valgimigli M, Garcia Garcia H, Vrijens B, Vranckx P, McFadden EP, Costa F, Pieper K, Vock DM, Zhang M, Van Es GA, Tricoci P, Baber U, Steg G, Montalescot G, Angiolillo DJ, Serruys PW, Farb A, Windecker S, Kastrati A, Colombo A, Feres F, Jüni P, Stone GW, Bhatt DL, Mehran R, Tijssen JGP.