Incomplete and Unreported: Failure to Report Results of Incomplete Studies Results in Publication Bias

T. Shamliyan, R. Kane
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引用次数: 2

Abstract

Background: Clinical research that is incomplete and unreported can lead to bias in health care decisions. Selective reporting of outcomes in clinical research overestimates the benefits and safety of treatments and threatens the integrity of systematic reviews of health care interventions. The Common Rule does not require that results be made available from clinical studies to research subjects and the scientific community. Methods: We analyzed all closed studies (i.e., no longer recruiting) registered in the online database ClinicalTrials.gov as of May 2010 to identify the number, length, and characteristics of complete and incomplete (terminated, suspended, or withdrawn) studies. Random samples of terminated studies, which were defined as studies in which the recruitment or enrollment of participants has been halted prematurely and will not resume, were analyzed to identify the reasons for termination and availability of the results in ClinicalTrials.gov or in published articles. Results: We identified 3,554 (6.2%) terminated studies among 57,233 closed studies. Reasons for termination were unknown in 34% and safety-related in 11% of terminated studies. Industry-funded studies omitted termination reasons less often than National Institutes of Health (NIH)-funded studies (OR 0.3, 95%CI: 0.1, 0.9). Drug studies omitted termination reasons more often than all other intervention studies. (OR 2; 95% CI: 1.1, 3.7) and also cited safety as the termination reason (OR 8.6; 95%CI: 1.9, 36.8) more often than other intervention studies. Terminated studies lasted on average 2.2 ± 1.9 years, and results were available for 5% in ClinicalTrials.gov and for 8% in peer-reviewed journals. Conclusions: Existing clinical research policies should mandate registration of all clinical trials in ClinicalTrials.gov as a condition of studies approval by institutional review boards. Mandatory posting of the results in ClinicalTrials.gov for all terminated studies, along with the exact reasons for termination irrespective of study funding and market or publication status, would enhance comprehensive evidence analysis by clinicians and policymakers, as well as public trust in clinical research.
不完整和未报告:未报告不完整研究的结果导致发表偏倚
背景:不完整和未报告的临床研究可能导致医疗保健决策的偏倚。临床研究结果的选择性报告高估了治疗的益处和安全性,并威胁到卫生保健干预措施系统评价的完整性。共同规则并不要求临床研究的结果必须提供给研究对象和科学界。方法:我们分析了截至2010年5月在线数据库ClinicalTrials.gov中注册的所有关闭研究(即不再招募),以确定完成和不完整(终止、暂停或撤回)研究的数量、长度和特征。对终止研究的随机样本进行分析,以确定终止的原因和ClinicalTrials.gov或已发表文章中结果的可用性,终止研究的定义是参与者的招募或入组过早停止且不会恢复的研究。结果:我们在57,233项关闭研究中确定了3,554项(6.2%)终止研究。34%的终止研究原因不明,11%的终止研究与安全有关。行业资助的研究比国家卫生研究院(NIH)资助的研究更少遗漏终止原因(OR 0.3, 95%CI: 0.1, 0.9)。药物研究比其他干预研究更容易忽略终止的原因。(或2;95% CI: 1.1, 3.7),并将安全作为终止原因(OR 8.6;95%CI: 1.9, 36.8)比其他干预研究更常见。终止研究的平均持续时间为2.2±1.9年,临床试验网站(ClinicalTrials.gov)上的结果为5%,同行评议期刊上的结果为8%。结论:现有的临床研究政策应该强制所有临床试验在ClinicalTrials.gov上注册,作为机构审查委员会批准研究的一个条件。在ClinicalTrials.gov上强制公布所有终止研究的结果,以及终止的确切原因,而不考虑研究资金、市场或出版状况,这将加强临床医生和决策者的全面证据分析,以及公众对临床研究的信任。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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