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.背景：目前学界对试验方案中工业界与学术研究者间的发表协议，以及此类协议与后续发表文献中相关表述的一致性尚缺乏了解。本研究旨在探究三个目标：其一，试验方案中发表协议的存在情况与类型；其二，此类协议在后续发表文献中的报告完整性与一致性；其三，工业界雇员作为共同作者的占比情况。 方法与结果：本研究采用回顾性队列研究设计，纳入2000年1月13日至2003年11月25日间经6家研究伦理委员会审批通过的存档随机对照试验（randomized clinical trial, RCT）方案，仅纳入有工业界参与的RCT。本研究对RCT方案中发表协议的记录情况，以及对应期刊发表文献中的相关表述展开了调研。在647份符合纳入标准的RCT方案中，456份（70.5%）提及了与研究结果发表相关的协议。在这456份提及相关协议的方案中，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%）的协议未对发表施加任何限制；剩余24份（5.3%）的方案提及了独立的协议文件，但本研究无法获取此类文件。在可获取发表协议的432份方案中，268项（62.0%）RCT的研究结果得以发表。绝大多数方案中记录的发表协议并未在后续发表的文献中得到报告（197/268 [73.5%]）。在71篇报告了发表协议的文献中，52篇（73.2%）的相关表述与试验方案中的记录一致。在37篇表述为发表权利不受限制的文献中，14篇（37.8%）至少有一名共同作者为工业界雇员。在25组方案-文献配对中，文献中的作者表述称发表不受任何限制，但对应试验方案中却记录了带有限制条款的发表协议。 结论：限制学术研究者发表独立性的发表协议较为常见。期刊论文极少报告发表协议相关内容，即便有所报告，其表述也可能与试验方案存在不一致。