学术界与行业赞助的试验:关于差异、相似性和未来改进的全球调查。

IF 4.5 3区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH
Jean-Marc Hoffmann, Annina Bauer, Regina Grossmann
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引用次数: 0

摘要

背景:临床研究具有多面性的特点,需要采用多种不同的方法、设计和目标,从而使临床试验的规划、启动和实施复杂化。在这种情况下,发起机构的作用和组织至关重要。我们的目的是调查学术界和产业界在临床试验的建立和实施过程中可能面临的挑战和需求,包括其背后的因素:我们在高水平学术研究机构(ARIs)的国际网络内开展了一项横向调查研究。主要结果指标包括临床试验的监管框架、学术界和产业界资助试验的范围和组织、学术界临床试验的资金来源、提交和审批流程,以及学术界与产业界资助试验的研究行为:我们对在 I-IV 期临床试验方面具有丰富经验的 ARI 员工进行了调查。所有的研究机构都参与了学术临床试验,90% 的研究机构参与了行业赞助的试验。受访者称,与行业赞助的试验相比,学术试验在与相关机构审查委员会/伦理委员会和主管部门沟通方面面临更大的挑战。此外,受访者还发现,学术试验在进行过程中获得的资金支持要少得多。学术界与产业界相比面临的具体挑战包括 "人力资源不足"(60% 对 50%)、"招聘问题"(60% 对 78%)和 "缺乏知识/经验"(35% 对 11%):我们的研究结果表明,与学术试验相比,行业赞助的试验在设立、资金和试验开展方面遇到的问题较少。要应对这些挑战,必须加强学术赞助者与 ARI 之间的合作。应用研究机构不仅在规划和实施项目方面,而且在评估可行性和获得资金方面,都为学术研究人员提供了重要的支持和指导。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Academic vs. industry-sponsored trials: A global survey on differences, similarities, and future improvements.

Background: Clinical research is marked by its multifaceted nature, presenting a multitude of different approaches, designs, and objectives that can complicate the planning, initiation, and conduct of clinical trials. The role and organisation of the sponsor institution are pivotal in this context. We aimed to investigate possible challenges and needs, including their underlying factors, for academia and industry during the set-up and conduct of clinical trials.

Methods: We conducted a cross-sectional survey-based study within an international network of highly qualified academic research institutions (ARIs). The main outcome measures were the regulatory framework for clinical trials, scope and organisation of academic and industry-sponsored trials, funding sources of academic clinical trials, submission and approval process, as well as study conduct of academic vs. industry-sponsored trials.

Results: We surveyed employees of ARIs with extensive experience in phase I-IV clinical trials. All ARIs participated in academic clinical trials and 90% were involved in industry-sponsored trials. Respondents reported that academic trials faced greater challenges in communication with relevant institutional review boards/ethics committees and competent authorities compared to industry-sponsored trials. Additionally, academic trials were found to have significantly less financial support during their conduct. Specific challenges for academia vs. industry included 'insufficient personnel resources' (60% vs. 50%), 'recruitment problems' (60% vs. 78%) and 'lack of knowledge/experience' (35% vs. 11%).

Conclusions: Our findings indicate that industry-sponsored trials encounter fewer issues in set-up, funding, and trial conduct compared to academic trials. Improving collaboration between academic sponsors and ARIs is essential to address these challenges. ARIs provide critical support and guidance for academic researchers, not only in planning and implementing projects, but also in assessing feasibility and securing funding.

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来源期刊
Journal of Global Health
Journal of Global Health PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH -
CiteScore
6.10
自引率
2.80%
发文量
240
审稿时长
6 weeks
期刊介绍: Journal of Global Health is a peer-reviewed journal published by the Edinburgh University Global Health Society, a not-for-profit organization registered in the UK. We publish editorials, news, viewpoints, original research and review articles in two issues per year.
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