与未能发表大型随机试验相关的因素在瘤学会议上提出
Monika K Krzyzanowska1, Melania Pintilie, Ian F Tannock
1Center for Outcomes and Policy Research, Department of Adult Oncology, Dana-Farber Cancer Institute, Boston, Mass, USA.
JAMA
|July 24, 2003
概括
许多大型临床试验在提交5年后仍然未公布,对公布不重要的结果有偏见. 这影响了医学文献和患者护理决策.
科学领域:
- 临床试验 临床试验
- 瘤学研究研究
- 出版偏见 出版偏见
背景情况:
- 大规模的临床试验对于治疗决策至关重要.
- 不公布试验结果可能会带来偏见,并导致不理想的医疗选择.
研究的目的:
- 评估在美国临床瘤学会 (ASCO) 会议上提交的大型随机试验的完整出版率.
- 量化与非显著发现的出版偏差.
- 确定影响出版时间的因素.
主要方法:
- 在ASCO会议 (1989-1998) 上提出的510个大型 (>=200名参与者),第三阶段,随机对照试验的调查.
- 将试验结果分类为显著 (P<=.05) 或非显著 (P>.05).
- 通过MEDLINE,EMBASE和Cochrane Register追踪到2002年11月的完整出版状况;如果未发表,作者会被联系.
主要成果:
- 26%的大型随机试验在提交5年内没有完全发表.
- 有意义结果的试验的发表率 (81%) 比无意义结果的试验 (68%) 高.
- 口头/全体会议演讲和制药公司的赞助与更快的出版时间有关.
结论:
- 大型瘤学试验的很大一部分在提交5年后仍未发表.
- 对非显著结果的出版偏见即使在大型,高影响力的试验中也存在.
- 不公布会破坏对参与者,资助者和审查委员会的道德义务.
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