Cerreta Francesca, Vučić Katarina, Laslop Andrea
Scientific Evidence Generation Department, European Medicines Agency (EMA), Amsterdam, The Netherlands.
Office of Therapies for Endocrine and Cardiovascular Diseases, Human Medicines Division, European Medicines Agency, Amsterdam, The Netherlands.
Clin Pharmacol Ther. 2023 Mar;113(3):536-540. doi: 10.1002/cpt.2793. Epub 2022 Nov 27.
The aging processes alter the body's response to a medicine's pharmacokinetics, pharmacodynamics, and susceptibility to adverse effects. In addition, older adults, especially the oldest age category (85+ years) or those with multiple chronic health conditions, polypharmacy, or frailty, are under-represented in clinical trials of new medicines. Evidence-based prescribing guidelines based on these trials might result in inappropriate prescription, increasing the risk of drug interactions and adverse drug reactions. Regulators face a conundrum between acquiring sufficient data and putting susceptible patients at risk in the early stages of a development program, when little is known about a medicine's effects. Healthcare professionals and patients deserve to have access to clear information on the knowledge and evidence gaps leading to the approval of a new medicinal product. This should also include proper consideration of the population of older patients. In the present article, we outline the approach taken by the European Medicines Agency (EMA) regulators in the assessment of a new medicine's dossier.
衰老过程会改变人体对药物药代动力学、药效学的反应以及对不良反应的易感性。此外，老年人，尤其是年龄最大的类别（85岁及以上）或患有多种慢性健康问题、同时服用多种药物或身体虚弱的老年人，在新药临床试验中的代表性不足。基于这些试验的循证处方指南可能会导致不适当的处方，增加药物相互作用和药物不良反应的风险。在新药研发项目的早期阶段，当对药物效果了解甚少时，监管机构面临着在获取足够数据与让易感患者面临风险之间的难题。医疗保健专业人员和患者有权获得关于导致新药获批的知识和证据空白的清晰信息。这还应包括对老年患者群体的适当考虑。在本文中，我们概述了欧洲药品管理局（EMA）监管机构在评估新药档案时所采用的方法。
