Data from: Agreements between industry and academia on publication rights: a retrospective study of protocols and publications of randomized clinical trials

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.研究背景：目前学界对试验方案中工业界与学术研究者间的出版协议，以及此类协议与出版物中对应表述的一致性尚且所知甚少。本研究旨在探究：（1）试验方案中出版协议的存在情况与类型；（2）后续出版物中此类协议报告的完整性与一致性；（3）工业界雇员作为共同作者的出现频率。 研究方法与结果：本研究采用回顾性队列设计，纳入2000年1月13日至2003年11月25日间经6家研究伦理委员会（Research Ethics Committees）审批通过的存档随机临床试验（Randomized Clinical Trials, RCTs）方案，仅纳入有工业界参与的RCTs。本研究对RCT方案中出版协议的文档记录，以及对应期刊出版物中的相关表述展开调研。在647份符合纳入标准的RCT方案中，456份（70.5%）提及了与研究结果出版相关的协议。其中393份（86.2%）记录了工业界合作方有权否决或至少审阅拟投稿的稿件；39份（8.6%）的协议无出版限制。剩余24份（5.3%）方案提及了独立的协议文档，但本研究无法获取此类文档。在可获取出版协议的432份方案中，268项（62.0%）试验已发表。绝大多数方案中记录的出版协议未在后续出版物中得到报告（197/268 [73.5%]）。在71项于出版物中报告的出版协议里，52项（73.2%）与方案中的记录相符。在37份表述出版权利不受限制的出版物中，14份（37.8%）至少有一位共同作者为工业界雇员。在25组方案-出版物配对中，出版物中的作者表述称无出版限制，但对应的18份方案却记录了带有限制的出版协议。 研究结论：限制学术作者独立性的出版协议较为常见。期刊论文极少报告出版协议相关内容，即便有所报告，其表述也可能与试验方案存在出入。