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首页> 外文期刊>BMJ: British medical journal >Benefits and harms in clinical trials of duloxetine for treatment of major depressive disorder: comparison of clinical study reports, trial registries, and publications
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Benefits and harms in clinical trials of duloxetine for treatment of major depressive disorder: comparison of clinical study reports, trial registries, and publications

机译:杜洛西汀对主要抑郁症治疗的临床试验中的益处和危害:临床研究报告,试验注册和出版物的比较

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摘要

Are there inconsistencies between protocols, clinical study reports, and main publicly available sources of trial data (journal articles and trial registries) and within clinical study reports themselves, with respect to benefits and harms of treatments? With research on duloxetine for major depressive disorder as an example, there were minor inconsistencies in the population used in the primary efficacy analysis between protocols and clinical study reports and within clinical study reports. There were also inconsistencies between different summaries and tabulations of harms data within clinical study reports. Meta-analyses of randomised clinical trials based on published data can overestimate the benefits and underestimate the harms of drugs, and a more reliable data source for meta-analyses is clinical study reports. This comparison of data sources showed inconsistencies in reported harms between different summaries and tabulations of data on harms within clinical study reports. Authors of systematic reviews should check clinical study reports for accuracy and consistency whenever possible.
机译:方案,临床研究报告和主要可公开可用的试验数据来源(期刊文章和试验注册机构)以及临床研究报告本身是否存在不一致之处?以对主要抑郁症的杜洛西汀的研究为例,在方案和临床研究报告之间以及临床研究报告中,主要疗效分析中使用的人群中使用了较小的矛盾。在临床研究报告中,不同的摘要与危害数据的列表之间也存在不一致之处。基于已公开数据的随机临床试验的荟萃分析可以高估药物的损害的好处,而荟萃分析的数据源更可靠,是临床研究报告。数据源的这种比较表明,在临床研究报告中,不同摘要与危害数据的数据列表之间的危害不一致。系统评价的作者应尽可能检查临床研究报告的准确性和一致性。

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