Drug related adverse event assessment in neonates in clinical trials and clinical care.

IF 3.6 3区 医学 Q2 PHARMACOLOGY & PHARMACY Expert Review of Clinical Pharmacology Pub Date : 2024-09-01 Epub Date: 2024-08-13 DOI:10.1080/17512433.2024.2390927
Nadir Yalcin, John van den Anker, Samira Samiee-Zafarghandy, Karel Allegaert
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Abstract

Introduction: Assessment of drug-related adverse events is essential to fully understand the benefit-risk balance of any drug exposure, weighing efficacy versus safety. This is needed for both drug labeling and clinical decision-making. Assessment is based on seriousness, severity and causality, be it more difficult to apply in neonates. Adverse event detection or prevention in the neonatal clinical setting is also more complicated because of polypharmacy, and off-label or unlicensed pharmacotherapy.

Areas covered: Tools became available to assess severity and causality of adverse events in neonates recruited in clinical trials. The first version of the Neonatal Adverse Event severity score (NAESS) reduced the inter-observer variability. Causality tools like the Naranjo score were also tailored to neonates. These tools are also instrumental to support proactive pharmacovigilance in clinical care, while multidisciplinary care teams and computerized pharmacovigilance using advanced data analysis, like machine learning are emerging approaches to develop effective decision strategies.

Expert opinion: All stakeholders involved in development of medicines or its clinical use should be aware of the limitations of the currently available assessment tools. Extension and optimization of these tools, advanced data analysis approaches, and capturing the variability in time-dependent physiology are warranted to improve pharmacovigilance in neonates.

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在临床试验和临床护理中对新生儿进行药物相关不良事件评估。
导言:评估与药物相关的不良事件对于充分了解任何药物暴露的效益与风险平衡、权衡疗效与安全性至关重要。这对于药物标签和临床决策都是必需的。评估以严重性、严重程度和因果关系为基础,但在新生儿中较难应用。新生儿临床环境中的不良事件检测或预防工作也更加复杂,因为新生儿使用多种药物、标签外或无证药物治疗:目前已有工具可用于评估临床试验中新生儿不良事件的严重性和因果关系。第一版新生儿不良事件严重程度评分(NAESS)减少了观察者之间的差异。纳兰霍评分等因果关系工具也是为新生儿量身定制的。这些工具还有助于支持临床护理中的前瞻性药物警戒,而多学科护理团队和使用先进数据分析(如机器学习)的计算机化药物警戒则是制定有效决策策略的新兴方法:专家意见:所有参与药品研发或临床使用的相关人员都应认识到现有评估工具的局限性。为了改善新生儿的药物警戒,有必要对这些工具进行扩展和优化,采用先进的数据分析方法,并捕捉随时间变化的生理变化。
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来源期刊
Expert Review of Clinical Pharmacology
Expert Review of Clinical Pharmacology PHARMACOLOGY & PHARMACY-
CiteScore
7.30
自引率
2.30%
发文量
127
期刊介绍: Advances in drug development technologies are yielding innovative new therapies, from potentially lifesaving medicines to lifestyle products. In recent years, however, the cost of developing new drugs has soared, and concerns over drug resistance and pharmacoeconomics have come to the fore. Adverse reactions experienced at the clinical trial level serve as a constant reminder of the importance of rigorous safety and toxicity testing. Furthermore the advent of pharmacogenomics and ‘individualized’ approaches to therapy will demand a fresh approach to drug evaluation and healthcare delivery. Clinical Pharmacology provides an essential role in integrating the expertise of all of the specialists and players who are active in meeting such challenges in modern biomedical practice.
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