Characteristics of funding of clinical trials: cross-sectional survey and proposed guidance.
Characteristics of funding of clinical trials: cross-sectional survey and proposed guidance.
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DOI：
10.1136/bmjopen-2017-015997
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发表时间：
2017-10-05
期刊：
影响因子：
2.9
通讯作者：
Akl EA
中科院分区：
文献类型：
--
作者：
Hakoum MB;Jouni N;Abou-Jaoude EA;Hasbani DJ;Abou-Jaoude EA;Lopes LC;Khaldieh M;Hammoud MZ;Al-Gibbawi M;Anouti S;Guyatt G;Akl EA
提供代表性样本临床试验资金的详细和当前特征。我们还旨在制定有关资金信息标准化报告的指南。我们讨论了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括关于资金来源的声明（例如，非营利组织是否得到私人营利组织的支持），资金类型，资助者的金额和角色。我们采用了逐步的方法来制定资助信息标准化报告的指南和工具。在200项试验中，178项（89%）包括资金声明，其中171项（96%）报告获得资金。171项资助试验的资金报表显示100%的资金来源，1%的金额和50%的资助者的角色。最常见的来源是政府（58%）和私人营利（40%）。在来源为非营利组织的54份资助声明中，我们发现26份（48%）来自私人营利组织的未公开支持的证据。在171项资助的试验中，资助者最常报告的角色与研究设计（42%）和数据分析，解释或管理（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，也涉及报告过程。该指南附有一份可填写的PDF文件，用作标准化报告供资信息的工具。尽管大多数RCT报告了资金，但在报告资金来源、金额和资助者角色方面存在相当大的差异。采用标准化的供资信息报告办法将解决这些限制。未来的研究应探讨由非营利组织资助的营利组织支持的资金的影响。
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.
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影响因子：
2.8
作者：
Clifford TJ;Barrowman NJ;Moher D
通讯作者：
Moher D
影响因子：
2.6
作者：
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通讯作者：
Tuech, Jean-Jacques
DOI：
10.1513/pats.200701-007gc
发表时间：
2007-05-01
期刊：
Proceedings of the American Thoracic Society
影响因子：
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作者：
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通讯作者：
Coultas, David
影响因子：
5.5
作者：
Aaron, Daniel G.;Siegel, Michael B.
通讯作者：
Siegel, Michael B.
影响因子：
2.9
作者：
Akl EA;Carrasco-Labra A;Brignardello-Petersen R;Neumann I;Johnston BC;Sun X;Briel M;Busse JW;Ebrahim S;Granados CE;Iorio A;Irfan A;Martínez García L;Mustafa RA;Ramírez-Morera A;Selva A;Solà I;Sanabria AJ;Tikkinen KA;Vandvik PO;Vernooij RW;Zazueta OE;Zhou Q;Guyatt GH;Alonso-Coello P
通讯作者：
Alonso-Coello P