Department of Primary Education, School of Education, University of Ioannina, Ioannina, Greece; Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada; Department of Surgery & Cancer, Institute of Reproductive and Developmental Biology, Faculty of Medicine, Imperial College, London, UK.
Knowledge Translation Program, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.
J Clin Epidemiol. 2019 Sep;113:176-188. doi: 10.1016/j.jclinepi.2019.05.031. Epub 2019 May 30.
The aim of the study was to examine the effect of providing a financial incentive to authors of randomized clinical trials (RCTs) to obtain individual patient data (IPD).
Parallel-group RCT with authors identified in the RCTs eligible for two systematic reviews. The authors were randomly allocated to the intervention (financial incentive with several contact approaches) or control group (using the same contact approaches). Studied outcomes are proportion of authors who provided IPD, time to obtain IPD, and completeness of IPD received.
Of the 129 authors contacted, 37 authors suggested or contacted a person or funder providing relevant details or showed interest to collaborate, whereas 45 authors directed us to contact a person or funder, lacked resources or time, did not have ownership or approval to share the IPD, or claimed IPD was too old. None of the authors shared their IPD. We contacted 17 sponsors and received two complete IPD datasets from one sponsor. The time to obtain IPD was >1 year after a sponsor's positive response. Common barriers included study identification, data ownership, limited data access, and required IPD licenses.
IPD sharing may depend on study characteristics, including funding type, study size, study risk of bias, and treatment effect, but not on providing a financial incentive.
本研究旨在考察为随机临床试验（RCT）的作者提供获取个体患者数据（IPD）的经济激励措施的效果。
这是一项平行组 RCT，符合两项系统评价条件的 RCT 作者有资格参与。作者被随机分配到干预组（经济激励措施，采用多种联系方式）或对照组（使用相同的联系方式）。研究结果为提供 IPD 的作者比例、获取 IPD 的时间以及收到的 IPD 的完整性。
在联系的 129 位作者中，有 37 位作者提供或联系了提供相关详细信息的人或资助者，或表现出合作的兴趣，而 45 位作者指导我们联系了人或资助者，缺乏资源或时间，对分享 IPD 没有所有权或批准，或者声称 IPD 太旧。没有一位作者分享他们的 IPD。我们联系了 17 个赞助商，并从一个赞助商那里收到了两个完整的 IPD 数据集。获取 IPD 的时间超过了赞助商做出积极回应后的 1 年。常见的障碍包括研究识别、数据所有权、有限的数据访问以及所需的 IPD 许可证。
IPD 的共享可能取决于研究特征，包括资助类型、研究规模、研究偏倚风险和治疗效果，但与提供经济激励无关。
