不确定性原则和行业赞助的研究
B Djulbegovic1, M Lacevic, A Cantor
1Division of Blood and Bone Marrow Transplantation, H Lee Moffitt Cancer Center and Research Institute at the University of South Florida, Tampa 33612, USA. djulbebm@moffitt.usf.edu
Lancet (London, England)
|September 1, 2000
概括
制药行业对临床试验的资助可能会带来偏见. 非营利性资助的研究更好地维护不确定性原则,确保更公平的治疗比较.
科学领域:
- 临床试验方法论 临床试验方法论
- 医学研究伦理学医学研究伦理学
- 制药业监督 制药业监督 制药业监督
背景情况:
- 制药行业赞助的随机临床试验 (RCT) 面临潜在偏见的审查.
- 偏见可能来自选择性报告或出版低质量的研究与不利的结果.
- 根据不确定性原则,只有当关于治疗疗效存在真正的不确定性时,才要求进行RCT.
研究的目的:
- 评估136个已发表的RCT中遵守不确定性原则.
- 分析资金来源对试验质量和遵守不确定性原则的影响.
- 调查制药行业赞助的研究中的潜在偏见.
主要方法:
- 在多发性骨髓瘤中检查了136个RCT,以遵守不确定性原则.
- 对比了偏好实验与标准治疗的研究比例.
- 根据资金来源 (营利性与非营利性) 分析了试验质量和遵守情况.
主要成果:
- 部分或全部由营利性组织资助的试验显示了更高质量得分的趋势 (p=0.06).
- 非营利性资助的研究更好地保持平衡 (47%对53%偏爱新疗法,p=0.608).
- 营利性资助的试验显示出对实验性治疗的明显偏见 (74%对26%,p=0.004).
结论:
- 违反不确定性原则可能解释了制药行业赞助的研究中报告的偏见.
- 鼓励透明的报告和适当的比较控制对于临床试验赞助商至关重要.
- 确保试验设计中的平衡对于公正的研究结果至关重要.
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