亚太学术瘤学临床试验的运营挑战
Daphne Day1,2, Han Chong Toh3, Raghib Ali4
1Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia.
JCO global oncology
|June 26, 2023
概括
在亚太地区 (APAC) 进行跨国学术临床试验,由于多样性而面临重大挑战. 该ASCOLT试验强调了需要协调的法规和协作联盟,以高效的瘤学研究.
科学领域:
- 瘤学 临床试验 临床试验
- 亚太地区医疗保健研究研究
- 多国研究协调多国研究协调.
背景情况:
- 亚太地区 (APAC) 是全球临床研究的关键区域.
- 亚太地区的文化,语言,经济和监管多样性为进行临床试验,特别是学术试验,造成了重大障碍.
研究的目的:
- 描述在亚太地区开展由研究人员发起的第三期阿司匹林对杜克斯C和高风险杜克斯B结肠直肠癌试验 (ASCOLT) 的经验和挑战.
- 确定关键因素,并提出提高亚太地区学术临床试验效率和以患者为中心的策略.
主要方法:
- ASCOLT试验 (N = 1,587) 是对阿司匹林在切除的高风险结直肠癌患者的第三期随机研究,在12个亚太国家/地区的74个地点进行.
- 中央协调由新加坡国家癌症中心管理,当地合作团体和合同研究组织积极参与,以应对复杂性.
主要成果:
- 该研究面临许多挑战,包括复杂的监管环境,沟通障碍,资金限制和特定地点的基础设施差异.
- 监管部门批准 (超过100个合同,49个伦理审查) 和网站启动 (大约100个合同,49个伦理审查) 需要相当长的时间. 每个地点6个月).
- 缓解策略包括向电子数据管理过渡,并使用集中式药物配送系统.
结论:
- 在亚太地区协调监管流程对于有效进行临床试验至关重要.
- 建立亚太学术瘤学试验联盟可以简化流程并提供必要的治理.
- 持续增长需要政府,资助机构和行业的持续承诺和合作.
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