工业资助试验和非工业资助试验的临床试验特征的比较
Emily Hughes1, Tamara Van Bakel2, Ashley Raudanskis1
1SINAI HEALTH SYSTEM, DIVISION OF GENERAL INTERNAL MEDICINE, TORONTO, ONTARIO, CANADA.
概括
行业资金没有影响随机对照试验 (RCT) 的质量. 研究特征,如盲目化和安慰剂使用,无论资助者类型如何,都相似.
科学领域:
- 临床研究方法论 临床研究方法论
- 基于证据的医学基于证据的医学.
- 生物医学研究评估 生物医学研究评估
背景情况:
- 行业资金是临床试验的常见来源.
- 人们担心行业资助的研究可能存在偏见.
- 评估随机对照试验 (RCT) 的方法质量对于可靠的证据至关重要.
研究的目的:
- 为了比较行业资助的RCT与非行业资助的RCT的研究特征.
- 确定资助者类型是否影响RCT的方法严格性.
- 调查资金来源和试验报告实践之间的关系.
主要方法:
- 研究特征的比较分析.
- 评估了697个由行业资助的RCT和835个非行业资助的RCT.
- 评估包括盲目的因素,安慰剂的使用,结果报告在clinicaltrials.gov.gov.
主要成果:
- 在高影响力期刊上发表的RCT更有可能被蒙蔽.
- 在高影响力期刊上的试验也更有可能包括安慰剂.
- 在高影响力期刊上发表与在clinicaltrials.gov上发布试验结果的可能性更高相关,无论资金来源如何.
结论:
- 一个RCT的资助者类型似乎不会影响其方法质量.
- 应强调基于方法论的严谨性来评估RCT,而不仅仅是基于资金来源.
- 通过发布结果等实践确保透明度对于所有临床试验至关重要.
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