从洞察到影响:对制药行业专业人员对患者参与价值的看法的定性研究。

IF 2.2 4区 医学 Q1 MEDICINE, GENERAL & INTERNAL
Current Medical Research and Opinion Pub Date : 2025-07-01 Epub Date: 2025-08-03 DOI:10.1080/03007995.2025.2537888
Fatima I Auwal, Elizabeth J Clark, Caroline S Copeland, Graham R McClelland
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引用次数: 0

摘要

患者参与(PE)越来越被认为是临床研究和药物开发的关键组成部分。然而,其执行情况仍然不一致,其影响的证据有限。目的:本研究探讨制药专业人员对PE在药物开发中的价值、挑战和促进因素的看法。方法:对来自欧洲和北美的28名行业专业人士进行在线访谈(2023年11月- 2024年5月)。数据分析采用归纳反身主题分析。结果:结果表明,尽管PE在加强试验设计、患者招募和保留、提高数据质量、监管成功和市场准入方面的潜力得到了认可,但证明其在这些领域的影响的证据仍然有限。重点强调的主要挑战是缺乏评估PE价值的标准化方法,一些地区患者组织的准入受限,以及使全球采用复杂化的监管要求的差异。此外,时间、资源限制和文化差异等实际障碍阻碍了一致和有意义的敬业实践的实施。该研究还确定了创建系统和一致的体育的一些潜在推动因素:使用数字工具,具有成本效益的参与方法,文化敏感的沟通方法,与患者倡导团体的合作伙伴关系,以及将体育建立为公认的科学学科。结论:本研究强调需要强有力的方法和标准化的PE实践来证明参与的回报及其对创新药物成功开发的贡献。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
From insight to impact: a qualitative study on pharmaceutical industry professionals' perceptions of the value of patient engagement.

Introduction: Patient engagement (PE) is increasingly recognised as a critical component of clinical research and pharmaceutical development. However, its implementation remains inconsistent, and evidence of its impact limited.

Objectives: This study explored pharmaceutical professionals' perspectives on the value, challenges, and facilitators of PE in medicine development.

Methods: Twenty-eight industry professionals from Europe and North America were interviewed online (November 2023-May 2024). Data were analysed using inductive reflexive thematic analysis.

Results: The result showed that while PE is acknowledged for its potential in enhancing trial design, patient recruitment and retention, enhancing data quality, regulatory success and market access - the evidence demonstrating its impact in these areas are still limited. Key challenges highlighted were the lack of standardised ways for assessing PE's value, limited access to patient organisations in some regions, and disparities in regulatory requirements that complicate global adoption. Additionally, practical barriers - such as time, resource constraints, and cultural differences, hinder the implementation of consistent and meaningful engagement practices. The study also identified a number of potential enablers for creating systematic and consistent PE: the use of digital tools, cost-effective engagement methods, culturally sensitive communication approaches, partnerships with patient advocacy groups and the establishment of PE as a recognised scientific discipline.

Conclusion: This research emphasised the need for robust methodologies and standardized PE practices to demonstrate return on engagement and its contribution to successful development of innovative medicines.

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来源期刊
Current Medical Research and Opinion
Current Medical Research and Opinion 医学-医学:内科
CiteScore
4.40
自引率
4.30%
发文量
247
审稿时长
3-8 weeks
期刊介绍: Current Medical Research and Opinion is a MEDLINE-indexed, peer-reviewed, international journal for the rapid publication of original research on new and existing drugs and therapies, Phase II-IV studies, and post-marketing investigations. Equivalence, safety and efficacy/effectiveness studies are especially encouraged. Preclinical, Phase I, pharmacoeconomic, outcomes and quality of life studies may also be considered if there is clear clinical relevance
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