Background/Aims:

Over the past decade, numerous data sharing platforms have been launched, providing access to de-identified individual patient-level data and supporting documentation. We evaluated the characteristics of prominent clinical data sharing platforms, including types of studies listed as available for request, data requests received, and rates of dissemination of research findings from data requests.

Methods:

We reviewed publicly available information listed on the websites of six prominent clinical data sharing platforms: Biological Specimen and Data Repository Information Coordinating Center, ClinicalStudyDataRequest.com, Project Data Sphere, Supporting Open Access to Researchers–Bristol Myers Squibb, Vivli, and the Yale Open Data Access Project. We recorded key platform characteristics, including listed studies and available supporting documentation, information on the number and status of data requests, and rates of dissemination of research findings from data requests (i.e. publications in a peer-reviewed journals, preprints, conference abstracts, or results reported on the platform’s website).

Results:

The number of clinical studies listed as available for request varied among five data sharing platforms: Biological Specimen and Data Repository Information Coordinating Center (n = 219), ClinicalStudyDataRequest.com (n = 2,897), Project Data Sphere (n = 154), Vivli (n = 5426), and the Yale Open Data Access Project (n = 395); Supporting Open Access to Researchers did not provide a list of Bristol Myers Squibb studies available for request. Individual patient-level data were nearly always reported as being available for request, as opposed to only Clinical Study Reports (Biological Specimen and Data Repository Information Coordinating Center = 211/219 (96.3%); ClinicalStudyDataRequest.com = 2884/2897 (99.6%); Project Data Sphere = 154/154 (100.0%); and the Yale Open Data Access Project = 355/395 (89.9%)); Vivli did not provide downloadable study metadata. Of 1201 data requests listed on ClinicalStudyDataRequest.com, Supporting Open Access to Researchers–Bristol Myers Squibb, Vivli, and the Yale Open Data Access Project platforms, 586 requests (48.8%) were approved (i.e. data access granted). The majority were for secondary analyses and/or developing/validating methods (ClinicalStudyDataRequest.com = 262/313 (83.7%); Supporting Open Access to Researchers–Bristol Myers Squibb = 22/30 (73.3%); Vivli = 63/84 (75.0%); the Yale Open Data Access Project = 111/159 (69.8%)); four were for re-analyses or corroborations of previous research findings (ClinicalStudyDataRequest.com = 3/313 (1.0%) and the Yale Open Data Access Project = 1/159 (0.6%)). Ninety-five (16.1%) approved data requests had results disseminated via peer-reviewed publications (ClinicalStudyDataRequest.com = 61/313 (19.5%); Supporting Open Access to Researchers–Bristol Myers Squibb = 3/30 (10.0%); Vivli = 4/84 (4.8%); the Yale Open Data Access Project = 27/159 (17.0%)). Forty-two (6.8%) additional requests reported results through preprints, conference abstracts, or on the platform’s website (ClinicalStudyDataRequest.com = 12/313 (3.8%); Supporting Open Access to Researchers–Bristol Myers Squibb = 3/30 (10.0%); Vivli = 2/84 (2.4%); Yale Open Data Access Project = 25/159 (15.7%)).

Conclusion:

Across six prominent clinical data sharing platforms, information on studies and request metrics varied in availability and format. Most data requests focused on secondary analyses and approximately one-quarter of all approved requests publicly disseminated their results. To further promote the use of shared clinical data, platforms should increase transparency, consistently clarify the availability of the listed studies and supporting documentation, and ensure that research findings from data requests are disseminated.

中文翻译：

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可用研究的特点和使用主要临床数据共享平台的研究传播

背景/目标：

在过去的十年中，已经启动了许多数据共享平台，提供对去识别的个人患者级别数据和支持文档的访问。我们评估了著名临床数据共享平台的特征，包括列出的可供请求的研究类型、收到的数据请求以及数据请求中研究结果的传播率。

方法：

我们审查了六个著名临床数据共享平台网站上列出的公开信息：生物样本和数据存储库信息协调中心、ClinicalStudyDataRequest.com、Project Data Sphere、支持对研究人员的开放访问——Bristol Myers Squibb、Vivli 和耶鲁公开赛数据访问项目。我们记录了关键的平台特征，包括列出的研究和可用的支持文件、关于数据请求的数量和状态的信息，以及数据请求中研究结果的传播率（即在同行评审期刊、预印本、会议摘要或平台网站上报告的结果）。

结果：

五个数据共享平台列出的可供请求的临床研究数量各不相同：生物样本和数据存储库信息协调中心 (n = 219)、ClinicalStudyDataRequest.com (n = 2,897)、Project Data Sphere (n = 154)、Vivli (n = 5426) 和耶鲁开放数据访问项目 (n = 395)；支持对研究人员的开放获取没有提供可供索取的百时美施贵宝研究列表。个体患者级别的数据几乎总是被报告为可供索取，而不仅仅是临床研究报告（生物样本和数据存储库信息协调中心 = 211/219 (96.3%)；ClinicalStudyDataRequest.com = 2884/2897 (99.6%) )；项目数据领域 = 154/154 (100.0%)；耶鲁开放数据访问项目 = 355/395 (89.9%))；Vivli 没有提供可下载的研究元数据。在 ClinicalStudyDataRequest.com 上列出的 1201 个数据请求中，支持对研究人员的开放访问——Bristol Myers Squibb、Vivli 和耶鲁开放数据访问项目平台，586 个请求（48.8%）被批准（即数据访问被批准）。大多数用于二次分析和/或开发/验证方法（ClinicalStudyDataRequest.com = 262/313 (83.7%)；支持对研究人员开放访问——百时美施贵宝 = 22/30 (73.3%)；Vivli = 63/84 ( 75.0%)；耶鲁开放数据访问项目 = 111/159 (69.8%))；四个用于重新分析或证实以前的研究结果（ClinicalStudyDataRequest.com = 3/313 (1.0%) 和耶鲁开放数据访问项目 = 1/159 (0.6%)）。九十五（16。1%) 批准的数据请求通过同行评审的出版物传播了结果（ClinicalStudyDataRequest.com = 61/313 (19.5%)；支持对研究人员的开放访问——百时美施贵宝 = 3/30 (10.0%)；Vivli = 4/84 (4.8%)；耶鲁开放数据访问项目 = 27/159 (17.0%))。42 个 (6.8%) 额外的请求通过预印本、会议摘要或平台网站报告了结果 (ClinicalStudyDataRequest.com = 12/313 (3.8%)；支持对研究人员的开放访问——百时美施贵宝 = 3/30 (10.0) %)；Vivli = 2/84 (2.4%)；耶鲁开放数据访问项目 = 25/159 (15.7%))。

结论：

在六个著名的临床数据共享平台中，研究信息和请求指标的可用性和格式各不相同。大多数数据请求都集中在二次分析上，大约四分之一的已批准请求公开了他们的结果。为了进一步促进共享临床数据的使用，平台应提高透明度，始终明确列出的研究和支持文件的可用性，并确保传播数据请求的研究结果。