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黑色素瘤随机对照试验的特征和研究浪费
Hongrui Chen1, Bin Sun1, Chen Hua1
1Department of Plastic & Reconstructive Surgery, Shanghai Ninth People's Hospital, affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Clinical and experimental dermatology
|June 24, 2024
概括
研究浪费在黑色素瘤临床试验中很普遍,近40%的随机对照试验 (RCT) 尚未发表. 识别防止研究浪费的因素可以提高未来黑色素瘤研究的效率.
科学领域:
- 在瘤学瘤学.
- 临床研究方法论 临床研究方法论
- 生物统计学 生物统计学
背景情况:
- 随机对照试验 (RCT) 对于推进黑色素瘤治疗至关重要.
- 研究浪费,定义为研究知识的产生和使用的低效率,是将试验结果转化为临床实践的重大障碍.
- 之前没有任何报告在黑色素瘤特定的RCT中量化研究浪费.
研究的目的:
- 在黑色素瘤的第三期和第四期随机对照试验 (RCT) 中系统评估研究浪费的程度.
- 在黑色素瘤RCT中确定与研究浪费相关的特征和因素.
主要方法:
- 针对2000年1月至2023年12月期间注册的III期和IV期黑色素瘤RCT,对ClinicalTrials.gov进行了全面的搜索.
- 出版和引用状态使用PubMed和Scopus进行了评估.
- 研究浪费被定义为包括不公布,报告不足和可避免的设计缺陷在内的标准,不包括由于出版滞后于2019年12月之后完成的试验.
主要成果:
- 在103个分析的RCT中,39.8%尚未发表,62.1%显示研究浪费.
- 在已发表的试验中,31%的报告不足,31%的设计缺陷是可以避免的.
- 以后的注册 (2010年后),跨国行为,多种药物干预和生存为主要结果等因素与减少研究浪费有关.
结论:
- 黑色素瘤RCT中很大一部分是研究浪费,这影响了治疗策略的有效推进.
- 了解对研究浪费的保护因素对于优化未来临床试验的设计和执行至关重要.
- 这些发现为改善新的黑色素瘤RCT的合理和有效进行提供了有价值的见解.
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