Eliasson Lina, Clifford Sarah, Mulick Amy, Jackson Christina, Vrijens Bernard
Sprout Behaviour Change Ltd, London, UK.
London School of Hygiene and Tropical Medicine, London, UK.
Br J Clin Pharmacol. 2020 Apr;86(4):687-697. doi: 10.1111/bcp.14240. Epub 2020 Feb 28.
Medication adherence in drug trials is suboptimal, affecting the quality of these studies and adding significant costs. Nonadherence in this setting can lead to null findings, unduly large sample sizes and the need for dose modification after a drug has been approved. Despite these drawbacks, adherence behaviours are not consistently measured, analysed or reported appropriately in trial settings. The ESPACOMP Medication Adherence Reporting Guideline (EMERGE) offers a solution by facilitating a sound protocol design that takes this crucial factor into account. This article summarises key evidence on traditional and newer measurements of adherence, discusses implementation in clinical trial settings and makes recommendations about the analysis and interpretation of adherence data. Given the potential benefits of this approach, the authors call on regulators and the pharmaceutical industry to endorse the EMERGE guideline.
药物试验中的用药依从性不理想，影响了这些研究的质量，并增加了巨大成本。在这种情况下，不依从可能导致无效结果、样本量过大以及药物获批后需要调整剂量。尽管存在这些缺点，但在试验环境中，依从行为并未得到一致的测量、分析或恰当报告。ESPACOMP用药依从性报告指南（EMERGE）通过促进一个将这一关键因素考虑在内的合理方案设计提供了一种解决方案。本文总结了关于传统和新型依从性测量方法的关键证据，讨论了在临床试验环境中的实施情况，并就依从性数据的分析和解读提出了建议。鉴于这种方法的潜在益处，作者呼吁监管机构和制药行业认可EMERGE指南。
