利用患者观点为更好的临床试验设计和实施提供信息:当前趋势和未来方向。

IF 3.1 Q2 PHARMACOLOGY & PHARMACY
Stuart D Faulkner, Fabian Somers, Mathieu Boudes, Begõna Nafria, Paul Robinson
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引用次数: 7

摘要

由于许多因素,包括创新药物的复杂性和证明与患者相关的结果的需要,展示PE的“增值”的愿望,以及与大流行相关的临床试验运行方式的变化,例如分散研究,患者参与药物开发的方法已经迅速改变。与此同时,在技术辅助下进行临床试验的方式、获取患者健康结果和偏好方面也发生了变化,社会对多样性和包容性的需求日益增加,并努力提高临床试验的效率、透明度和问责制。组织开始更有效地监控体育活动和结果,以学习和告知未来的体育战略。因此,这些因素比以往任何时候都更有助于将患者的生活经验、偏好和需求纳入临床试验的设计和运行中。在本文中,作者反思了过去几年的新趋势及其驱动因素,以及在不久的将来我们可以期待PE在临床研究中的进展。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Using Patient Perspectives to Inform Better Clinical Trial Design and Conduct: Current Trends and Future Directions.

The approach to patient engagement (PE) in drug development has changed rapidly due to many factors, including the complexity of innovative drugs and the need to demonstrate outcomes of relevance to patients, the desire to show 'value add' of PE, and the pandemic-related changes to how clinical trials are run, e.g., decentralised studies. In parallel, there have been changes in technology-assisted ways of running clinical trials, capturing patient health outcomes and preferences, an increasing societal demand for diversity and inclusion, and efforts to improve clinical trial efficiency, transparency, and accountability. Organisations are beginning to monitor PE activities and outcomes more effectively to learn and inform future PE strategies. As a result, these factors are facilitating the incorporation of patients' lived experience, preferences and needs into the design and running of clinical trials more than ever before. In this paper, the authors reflect upon these last few years, the emerging trends and their drivers, and where we may expect PE in clinical research to progress in the near future.

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来源期刊
Pharmaceutical Medicine
Pharmaceutical Medicine PHARMACOLOGY & PHARMACY-
CiteScore
5.10
自引率
4.00%
发文量
36
期刊介绍: Pharmaceutical Medicine is a specialist discipline concerned with medical aspects of the discovery, development, evaluation, registration, regulation, monitoring, marketing, distribution and pricing of medicines, drug-device and drug-diagnostic combinations. The Journal disseminates information to support the community of professionals working in these highly inter-related functions. Key areas include translational medicine, clinical trial design, pharmacovigilance, clinical toxicology, drug regulation, clinical pharmacology, biostatistics and pharmacoeconomics. The Journal includes:Overviews of contentious or emerging issues.Comprehensive narrative reviews that provide an authoritative source of information on topical issues.Systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by PRISMA statement.Original research articles reporting the results of well-designed studies with a strong link to wider areas of clinical research.Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Pharmaceutical Medicine may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.All manuscripts are subject to peer review by international experts. Letters to the Editor are welcomed and will be considered for publication.
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