Differences in Reporting of Analyses in Internal Company Documents Versus Published Trial Reports: Comparisons in Industry-Sponsored Trials in Off-Label Uses of Gabapentin
Differences in Reporting of Analyses in Internal Company Documents Versus Published Trial Reports: Comparisons in Industry-Sponsored Trials in Off-Label Uses of Gabapentin
复制标题
DOI：
10.1371/journal.pmed.1001378
复制
发表时间：
2013-01-01
期刊：
影响因子：
15.8
通讯作者：
Dickersin, Kay
中科院分区：
文献类型：
--
作者：
Vedula, S. Swaroop;Li, Tianjing;Dickersin, Kay
背景：关于分析类型的详细信息（e）。例如，在一个实施例中，意图治疗[ITT]）和定义（即，将参与者纳入分析的标准）对于解释临床试验的结果是必要的。我们的目的是比较分析类型的描述和纳入出版物参与者的标准（即，报告了什么）以及相应的内部公司文档中的描述（即，计划和做了什么）。试验是由辉瑞公司和帕克-戴维斯赞助的加巴喷丁的标签外使用，并通过诉讼获得文件。方法和结果：对于每项试验，我们比较了内部公司文件（协议，统计分析计划，研究报告，所有未发表），出版物。一个作者提取数据，另一个人进行验证，第三个人验证不一致的项目，其余的样本。提取的数据包括随机化和有效性分析的受试者数量，有效性和安全性分析的类型及其定义（即，将参与者纳入每种类型分析的标准）。我们确定了21项试验，其中11项是已发表的随机对照试验，并提供了计划比较所需的文件。对于三项试验，研究报告和出版物之间的随机参与者数量存在分歧。在方案、统计分析计划和出版物中描述了7种类型的疗效分析，包括ITT和其他6种。方案或出版物使用六种不同的定义描述ITT，导致两个文件之间经常出现分歧（即，不同数量的参与者被包括在分析中）。结论：对所进行分析的描述在公司内部文件和公开报道之间不一致。公司内部文件提供了计划和使用的方法以及试验结果的广泛文件，并应公开查阅。随机对照试验的报告标准应建议对所进行的分析进行透明的描述和定义，以及排除哪些研究参与者。
Background: Details about the type of analysis (e. g., intent to treat [ITT]) and definitions (i.e., criteria for including participants in the analysis) are necessary for interpreting a clinical trial's findings. Our objective was to compare the description of types of analyses and criteria for including participants in the publication (i.e., what was reported) with descriptions in the corresponding internal company documents (i.e., what was planned and what was done). Trials were for off-label uses of gabapentin sponsored by Pfizer and Parke-Davis, and documents were obtained through litigation.Methods and Findings: For each trial, we compared internal company documents (protocols, statistical analysis plans, and research reports, all unpublished), with publications. One author extracted data and another verified, with a third person verifying discordant items and a sample of the rest. Extracted data included the number of participants randomized and analyzed for efficacy, and types of analyses for efficacy and safety and their definitions (i.e., criteria for including participants in each type of analysis). We identified 21 trials, 11 of which were published randomized controlled trials, and that provided the documents needed for planned comparisons. For three trials, there was disagreement on the number of randomized participants between the research report and publication. Seven types of efficacy analyses were described in the protocols, statistical analysis plans, and publications, including ITT and six others. The protocol or publication described ITT using six different definitions, resulting in frequent disagreements between the two documents (i.e., different numbers of participants were included in the analyses).Conclusions: Descriptions of analyses conducted did not agree between internal company documents and what was publicly reported. Internal company documents provide extensive documentation of methods planned and used, and trial findings, and should be publicly accessible. Reporting standards for randomized controlled trials should recommend transparent descriptions and definitions of analyses performed and which study participants are excluded.