Hakoum Maram B, Jouni Nahla, Abou-Jaoude Eliane A, Hasbani Divina Justina, Abou-Jaoude Elias A, Lopes Luciane Cruz, Khaldieh Mariam, Hammoud Mira Zein, Al-Gibbawi Mounir, Anouti Sirine, Guyatt Gordon, Akl Elie A
Clinical Research Institute, American University of Beirut Medical Center, Beirut, Lebanon.
Faculty of Agriculture and Food Sciences, American University of Beirut, Beirut, Lebanon.
BMJ Open. 2017 Oct 5;7(10):e015997. doi: 10.1136/bmjopen-2017-015997.
To provide a detailed and current characterisation of funding of a representative sample clinical trials. We also aimed to develop guidance for standardised reporting of funding information.
We addressed the extent to which clinical trials published in 2015 in any of the 119 Core Clinical Journals included a statement on the funding source (eg, whether a not-for-profit organisation was supported by a private-for-profit organisation), type of funding, amount and role of funder. We used a stepwise approach to develop a guidance and an instrument for standardised reporting of funding information.
Of 200 trials, 178 (89%) included a funding statement, of which 171 (96%) reported being funded. Funding statements in the 171 funded trials indicated the source in 100%, amount in 1% and roles of funders in 50%. The most frequent sources were governmental (58%) and private-for-profit (40%). Of 54 funding statements in which the source was a not-for-profit organisation, we found evidence of undisclosed support of those from private-for-profit organisation(s) in 26 (48%). The most frequently reported roles of funders in the 171 funded trials related to study design (42%) and data analysis, interpretation or management (41%). Of 139 randomised controlled trials (RCTs) addressing pharmacological or surgical interventions, 29 (21%) reported information on the supplier of the medication or device. The proposed guidance addresses both the funding information that RCTs should report and the reporting process. Attached to the guidance is a fillable PDF document for use as an instrument for standardised reporting of funding information.
Although the majority of RCTs report funding, there is considerable variability in the reporting of funding source, amount and roles of funders. A standardised approach to reporting of funding information would address these limitations. Future research should explore the implications of funding by not-for-profit organisations that are supported by for-profit organisations.
对具有代表性的样本临床试验的资金情况进行详细且最新的描述。我们还旨在制定资金信息标准化报告的指南。
我们研究了2015年在119种核心临床期刊中发表的临床试验在多大程度上包含了关于资金来源的声明（例如，非营利组织是否得到营利性组织的支持）、资金类型、金额以及资助者的作用。我们采用逐步推进的方法来制定资金信息标准化报告的指南和工具。
在200项试验中，178项（89%）包含资金声明，其中171项（96%）报告获得了资助。171项获得资助的试验中的资金声明显示，100%说明了资金来源，1%说明了金额，50%说明了资助者的作用。最常见的资金来源是政府（58%）和营利性组织（40%）。在来源为非营利组织的54份资金声明中，我们发现有26份（48%）存在营利性组织对其未披露支持的证据。在171项获得资助的试验中，资助者最常被报告的作用与研究设计（42%）以及数据分析、解读或管理（41%）有关。在139项涉及药物或手术干预的随机对照试验（RCT）中，29项（21%）报告了药物或器械供应商的信息。拟议的指南既涉及RCT应报告的资金信息，也涉及报告流程。该指南附有一份可填写的PDF文档，用作资金信息标准化报告的工具。
尽管大多数RCT报告了资金情况，但在资金来源报告、金额以及资助者作用方面存在相当大的差异。资金信息报告的标准化方法将解决这些局限性问题。未来的研究应探讨由营利性组织支持的非营利组织提供资金所产生的影响。
