多国制药公司对沙特阿拉伯临床试验分配的看法 - - 定性研究
Nouf M Aloudah1, Ahmed M Shaman1
1Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh 11523, Saudi Arabia.
Pharmacy (Basel, Switzerland)
|November 25, 2024
概括
制药公司在沙特阿拉伯面临着运营和监管障碍.
科学领域:
- 临床研究 临床研究
- 制药行业 制药行业 制药行业
- 沙特阿拉伯 医疗保健 医疗保健
背景情况:
- 临床试验对于将本地研究转化为广泛解决方案至关重要.
- 沙特阿拉伯的制药市场是该地区最大的,超过了130亿沙尔.
- 自2010年以来,该国对医疗保健基础设施进行了大量投资.
研究的目的:
- 探索沙特阿拉伯临床试验的障碍和促进者.
- 了解制药行业和合同研究组织 (CRO) 人员的观点.
- 确定影响该地区临床试验进行的关键主题.
主要方法:
- 与9名关键人员进行了深入的半结构化采访.
- 面试数据的定性分析.
- 探索运营,监管和价值主张方面的问题.
主要成果:
- 确定了运营挑战和监管审批复杂性,导致试验延迟.
- 强调该地区在糖尿病,朝圣健康和罕见疾病方面的试验潜力.
- 尽管市场规模很大,但临床试验注册的数量有限 (2009-2020年为354例).
结论:
- 解决监管障碍和简化流程对于吸引更多临床试验至关重要.
- 加强利益相关者的协调和利用医疗保健投资可以使沙特阿拉伯成为一个研究中心.
- 需要有针对性的干预措施来克服障碍,促进国际临床研究合作.
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