学术与行业赞助的试验:关于差异,相似之处和未来改进的全球调查
Jean-Marc Hoffmann1, Annina Bauer1,2, Regina Grossmann1
1Clinical Trials Center, University of Zurich/University Hospital Zurich, Zurich, Switzerland.
Journal of global health
|November 22, 2024
概括
工业赞助的临床试验比学术试验面临的挑战更少,特别是在资金和实施方面. 加强学术赞助商和研究机构之间的合作对于克服这些障碍至关重要.
科学领域:
- 临床研究 临床研究
- 药物开发 药物开发
- 监管事务 监管事务
背景情况:
- 临床试验是复杂的,具有不同的设计和目标.
- 赞助机构的组织对于试验的成功至关重要.
- 研究学术与行业临床试验设置和进行中的挑战是必不可少的.
研究的目的:
- 确定学术和行业临床试验中的挑战和需求.
- 为了比较学术和行业赞助的试验的设置和进行.
- 探索影响这些挑战的因素.
主要方法:
- 在国际学术研究机构 (ARI) 网络中的横截面调查.
- 评估了监管框架,试验范围,组织,资金和行为.
- 被调查的经验丰富的员工参与了I-IV期临床试验.
主要成果:
- 学术试验面临着与IRB/EC和主管当局的更大的沟通挑战.
- 学术试验报告说,在进行过程中,财务支持显著减少.
- 主要挑战:人力不足 (60%的学术界与50%的工业界),招聘 (60%的学术界与78%的工业界) 和知识差距 (35%的学术界与11%的工业界).
结论:
- 工业赞助的试验通常经历更顺的设置,资金和进行.
- 学术赞助商和ARI之间加强合作至关重要.
- 在支持研究人员进行规划,可行性和资助方面,ARI发挥着关键作用.
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