research funding

研究经费
  • 文章类型: Journal Article
    背景:制造成本缺乏透明度,谁承担大部分研发成本,以及总成本与产品定价的关系,继续推动辩论。本文考虑了奥拉帕利(Lynparza®)的案例,最近用于BRCA突变乳腺癌患者,并估计公共和慈善研发资金的范围。
    方法:我们从以前的工作中知道,试图使用纯粹的书目来源来确定公共和慈善资金的数量(即,作者对资金来源和通过资助者追踪的金额的声明)是有限的。既然我们知道公共资助的研究单位在开发奥拉帕利方面至关重要,我们决定用信息自由请求补充书目数据,以获取该研究中心研究经费数据的行政记录。
    方法:就产品开发阶段而言,在临床前研究阶段进行的工作最有可能报告非行业资助(>90%的临床前项目获得了公共或慈善资助).临床试验最不可能通过非行业来源资助-尽管即使在这里,与普遍的说法相反,这是完全由行业资助的,我们发现23%的临床试验申报了公共或慈善基金。利用出版物中报告的信息,我们确定了约1.28亿英镑的公共和慈善资金,可能有助于奥拉帕利的发展。然而,这一数额不到一家在产品发现中发挥关键作用的研究所收到的总额的三分之一。癌症研究所报告说,获得了38项资助,以支持奥拉帕尼对BRCA突变乳腺癌的工作,总额超过4亿英镑。
    结论:药品开发的政府或慈善资金很难使用公开来源进行追踪,由于作者提供的信息不完整和/或资助者提供的资金信息缺乏一致性。这项研究表明,信息自由的要求,在支持此类请求的国家,可以提供信息来帮助构建财政支持的画面。在奥拉帕利的例子中,直接报告的资金数额大大超过了使用公开书目来源可以确定的数额。
    BACKGROUND: Lack of transparency around manufacturing costs, who bears the bulk of research and development costs and how total costs relate to the pricing of products, continue to fuel debates. This paper considers the case of olaparib (Lynparza®), recently indicated for use among BRCA-mutant breast cancer patients, and estimates the extent of public and philanthropic R&D funding.
    METHODS: We know from previous work that attempting to ascertain the amount of public and philanthropic funding using purely bibliographic sources (i.e., authors\' declarations of funding sources and amounts traced through funders) is limited. Since we knew that a publically funded research unit was pivotal in developing olaparib, we decided to supplement bibliographic data with a Freedom of Information request for administrative records on research funding data from this research centre.
    METHODS: In terms of stages of product development, work conducted in the pre-clinical research stage was the most likely to report non-industry funding (> 90% of pre-clinical projects received public or philanthropic funding). Clinical trials were least likely to be funded through non-industry sources-although even here, contrary to the popular assertion that this is wholly industry-financed, we found public or philanthropic funding declared by 23% of clinical trials. Using information reported in the publications, we identified approximately £128 million of public and philanthropic funding that may have contributed to the development of olaparib. However, this amount was less than one-third of the total amount received by one research institute playing a pivotal role in product discovery. The Institute of Cancer Research reported receiving 38 funding awards to support olaparib work for BRCA-mutant breast cancer totalling over £400 million.
    CONCLUSIONS: Government or charitable funding of pharmaceutical product development is difficult to trace using publicly available sources, due to incomplete information provided by authors and/or a lack of consistency in funding information made available by funders. This study has shown that a Freedom of Information request, in countries where such requests are supported, can provide information to help build the picture of financial support. In the example of olaparib, the funding amounts directly reported considerably exceeded amounts that could be ascertained using publically available bibliographic sources.
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  • 文章类型: Journal Article
    背景:注册报告(RR)可能是提高科学研究和文献质量的一种方法,例如通过减少出版偏见和增加研究设计的严谨性。这些潜在的好处导致了研究资助者和学术期刊之间的注册报告资助伙伴关系(RRFP或简称伙伴关系),他们合作鼓励研究人员发表RRs。在这项研究中,我们调查了研究问题:“利益相关者的经验是什么(作者,审稿人,期刊编辑,资助者)在各种伙伴关系模式中?\"我们的同伴论文讨论了一个相关的,但是分开的,研究问题。方法:我们对32位半结构化的利益相关者(资助者,编辑,作者,审稿人,媒人)来自六个合伙企业。结果:受访者的认知和经历差异很大,反映了伙伴关系的复杂和微妙的影响。我们确定了6个主题:“与作者和审稿人沟通的重要性”,“对学习设计的影响”,“合作伙伴的适当性”,“减少出版偏见的潜力”,\"对审阅者工作负载的影响\",和“证据不足”。结论:这是对这些新举措的首次调查。我们希望我们的发现能够有益于并塑造当前和未来的伙伴关系。
    Background: Registered Reports (RRs) could be a way to increase the quality of scientific research and literature, such as by reducing publication bias and increasing the rigour of study designs. These potential benefits have led to Registered Report funding partnerships (RRFPs or partnerships for short) between research funders and academic journals who collaborate to encourage researchers to publish RRs. In this study we investigated the research question: \"What are the experiences of the stakeholders (authors, reviewers, journal editors, funders) in the various partnership models?\". Our companion paper addresses a related, but separate, research question. Methods: We conducted a thematic analysis of 32 semi-structured interviews with stakeholders (funders, editors, authors, reviewers, matchmakers) from six partnerships. Results: Interviewees had highly variable perceptions and experiences, reflecting the complex and nuanced impacts of partnerships. We identified 6 themes: \"Importance of communication with authors and reviewers\", \"Influence on study design\", \"Appropriateness of partners\", \"Potential to reduce publication bias\", \"Impact on reviewer workload\", and \"Insufficient evidence\". Conclusions: This was the first investigation into these novel initiatives. We hope that our findings can benefit and shape current and future partnerships.
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  • 文章类型: Journal Article
    BACKGROUND: The Patient-Centered Outcomes Research Institute (PCORI) is obligated to peer review and to post publicly \"Final Research Reports\" of all funded projects. PCORI peer review emphasizes adherence to PCORI\'s Methodology Standards and principles of ethical scientific communication. During the peer review process, reviewers and editors seek to ensure that results are presented objectively and interpreted appropriately, e.g., free of spin.
    METHODS: Two independent raters assessed PCORI peer review feedback sent to authors. We calculated the proportion of reports in which spin was identified during peer review, and the types of spin identified. We included reports submitted by April 2018 with at least one associated journal article. The same raters then assessed whether authors addressed reviewers\' comments about spin. The raters also assessed whether spin identified during PCORI peer review was present in related journal articles.
    RESULTS: We included 64 PCORI-funded projects. Peer reviewers or editors identified spin in 55/64 (86%) submitted research reports. Types of spin included reporting bias (46/55; 84%), inappropriate interpretation (40/55; 73%), inappropriate extrapolation of results (15/55; 27%), and inappropriate attribution of causality (5/55; 9%). Authors addressed comments about spin related to 47/55 (85%) of the reports. Of 110 associated journal articles, PCORI comments about spin were potentially applicable to 44/110 (40%) articles, of which 27/44 (61%) contained the same spin that was identified in the PCORI research report. The proportion of articles with spin was similar for articles accepted before and after PCORI peer review (63% vs 58%).
    CONCLUSIONS: Just as spin is common in journal articles and press releases, we found that most reports submitted to PCORI included spin. While most spin was mitigated during the funder\'s peer review process, we found no evidence that review of PCORI reports influenced spin in journal articles. Funders could explore interventions aimed at reducing spin in published articles of studies they support.
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  • 文章类型: Editorial
    暂无摘要。
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  • 文章类型: Journal Article
    对商业资助研究中利益冲突的担忧产生了越来越多的披露要求,但是这些足以评估影响力吗?以可口可乐公司为例,我们探索它的研究协议,以了解影响。信息自由请求确定了87,013页的文件,包括可口可乐与美国公共机构之间的五项协议,和加拿大。我们评估他们是否允许可口可乐行使控制权或影响力。条款赋予了可口可乐在出版前审查研究的权利,以及对(1)研究数据的控制,(2)披露结果和(3)承认可口可乐的资助。一些协议规定,在批准研究人员的最终报告之前,可口可乐对同行评审论文的发表有最终决定权。如果需要,因此,可口可乐可以防止不利研究的发表,但我们在收到的邮件中没有发现这方面的证据.这些文件还显示,研究人员可以与资助者成功谈判,以删除他们研究的限制性条款。我们建议期刊通过要求作者附上资助者协议来补充资金披露和利益冲突声明。
    Concerns about conflicts of interest in commercially funded research have generated increasing disclosure requirements, but are these enough to assess influence? Using the Coca-Cola Company as an example, we explore its research agreements to understand influence. Freedom of Information requests identified 87,013 pages of documents, including five agreements between Coca-Cola and public institutions in the United States, and Canada. We assess whether they allowed Coca-Cola to exercise control or influence. Provisions gave Coca-Cola the right to review research in advance of publication as well as control over (1) study data, (2) disclosure of results and (3) acknowledgement of Coca-Cola funding. Some agreements specified that Coca-Cola has the ultimate decision about any publication of peer-reviewed papers prior to its approval of the researchers\' final report. If so desired, Coca-Cola can thus prevent publication of unfavourable research, but we found no evidence of this to date in the emails we received. The documents also reveal researchers can negotiate with funders successfully to remove restrictive clauses on their research. We recommend journals supplement funding disclosures and conflict-of-interest statements by requiring authors to attach funder agreements.
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