Medication adherence is a key factor impacting efficacy and safety of medicines, yet how it is dealt with in European registration trials is unknown. A cross-sectional analysis of European Medicines Agency (EMA) marketing authorization dossiers for new medicines approved through centralized procedures in the European Union between 2010 and 2020 was performed. Data were extracted from European Public Assessment Reports and Clinical Study Reports. Clinical trials covering five therapeutic areas were included: diabetes, respiratory conditions, cardiovascular diseases, infectious diseases, and oncology. Outcomes included adherence assessment, measurement methods, and rates. Overall, 102 medicines studied in 253 clinical trials were reviewed. All but one study reported measuring adherence. Two hundred twenty trials (87%) measured adherence using quantitative methods, while 32 (13%) trials monitored adherence but did not further quantify. Reported adherence rates were high (> 90%) across trials yet marked disparities in measurement methods and definitions were found. The most frequently used adherence measurement method was pill/dose count (single method: 52.7%; in combination: 37.7%; with patient diary/report: 17.3%; electronic methods: 1.4%; bioanalytical methods: 4.1%). Patient diary/report (6.4%) and electronic methods (2.7%) were also used as single methods. Electronic methods were more often used in respiratory and anti-infective trials, while bioanalytical methods were more frequently used in diabetes. Overall, adherence is measured in EMA registration trials, yet the methods used and the way in which adherence rates are presented vary widely between trials and therapeutic areas. To better understand and compare efficacy of medicines, standardization of adherence definitions and measurement methods is needed.

中文翻译：

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支持新药批准的注册试验中的药物依从性测量方法：2010-2020 年欧盟集中程序的横断面分析

服药依从性是影响药物疗效和安全性的关键因素，但在欧洲注册试验中如何处理依从性尚不清楚。对 2010 年至 2020 年间欧盟通过集中程序批准的新药的欧洲药品管理局 (EMA) 上市许可档案进行了横断面分析。数据摘自欧洲公共评估报告和临床研究报告。涵盖五个治疗领域的临床试验包括：糖尿病、呼吸系统疾病、心血管疾病、传染病和肿瘤学。结果包括依从性评估、测量方法和比率。总体而言，对 253 项临床试验中研究的 102 种药物进行了审查。除了一项研究外，所有研究都报告了测量依从性。220 项试验 (87%) 使用定量方法测量依从性，而 32 项 (13%) 试验监测依从性但未进一步量化。各试验报告的依从率很高 (> 90%)，但发现测量方法和定义存在显着差异。最常用的依从性测量方法是药丸/剂量计数（单一方法：52.7%；组合：37.7%；患者日记/报告：17.3%；电子方法：1.4%；生物分析方法：4.1%）。患者日记/报告 (6.4%) 和电子方法 (2.7%) 也用作单一方法。电子方法更常用于呼吸和抗感染试验，而生物分析方法更常用于糖尿病。总体而言，依从性是在 EMA 注册试验中衡量的，然而，所使用的方法和显示依从率的方式在试验和治疗领域之间差异很大。为了更好地理解和比较药物的疗效，需要对依从性定义和测量方法进行标准化。