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首页> 外文期刊>PLoS Medicine >Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials
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Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials

机译：出版物行业与学术界的协议：对随机临床试验的协议和出版物的回顾性研究

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Background Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees. Methods and Findings We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5%) mentioned an agreement regarding publication of results. Of these 456, 393 (86.2%) documented an industry partner’s right to disapprove or at least review proposed manuscripts; 39 (8.6%) agreements were without constraints of publication. The remaining 24 (5.3%) protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0%) trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]). Of 71 agreements reported in publications, 52 (73.2%) were concordant with those documented in the protocol. In 14 of 37 (37.8%) publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements. Conclusions Publication agreements constraining academic authors’ independence are common. Journal articles seldom report on publication agreements, and, if they do, statements can be discrepant with the trial protocol.
机译：背景技术对于在审判协议中的行业和学术调查人员之间的出版协议以及这些协议与出版物中的相应陈述之间的一致性知之甚少。我们旨在调查（i）审判议定书中的出版协议的存在和类型，（ii）在随后的出版物中报告这些协议的完整性和一致性，并由行业员工的共同作者频率。方法和调查结果我们利用了基于六个研究伦理委员会于2000年1月13日至2003年11月13日至11月25日批准的归档协议进行了回顾性临床试验（RCT）。只有行业参与的RCT有资格。我们调查了对应期刊出版物中的RCT协议和陈述中的出版协议文件。 647符合条件的RCT协议，456（70.5％）提到了关于出版结果的协议。其中456,393（86.2％）记录了行业合作伙伴不赞成或至少审查拟议的稿件; 39（8.6％）协议没有发表的制约。剩下的24（5.3％）议定书提到了我们无法访问的单独协议文件。在那些有可访问的出版协议的432项协议中，发表了268名（62.0％）试验。在随后的出版物（197/268 [73.5％]）中没有报告议定书中的大多数协议。在出版物中报告的71个协议，52名（73.2％）与议定书中文件的协调人士协调一致。在37个（37.8％）出版物中，陈述提出不受限制的出版物权利，至少有一个合作者是一个行业员工。在25个协议出版对中，出版物中的作者陈述没有提出约束，但18个相应的协议记录了限制协议。结论出版协议约束学术作者的独立性是常见的。期刊文章很少关于出版协议的报告，如果他们这样做，则可以使用试验方案差异差异。

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