Johnson Austin L, Anderson J Michael, Bouvette Max, Pinero Israel, Rauh Shelby, Johnson Bradley, Kee Micah, Heigle Benjamin, Tricco Andrea C, Page Matthew J, McCall Wright Patti, Vassar Matt
Oklahoma State University Center for Health Sciences, Tulsa, OK, USA; The University of Texas Medical Branch, Galveston, TX, USA.
Oklahoma State University Center for Health Sciences, Tulsa, OK, USA.
J Clin Epidemiol. 2023 Feb;154:42-55. doi: 10.1016/j.jclinepi.2022.11.009. Epub 2022 Nov 12.
To identify the similarities and differences in data-sharing policies for clinical trial data that are endorsed by biomedical journals, funding agencies, and other professional organizations. Additionally, to determine the beliefs, and opinions regarding data-sharing policies for clinical trials discussed in articles published in biomedical journals.
Two searches were conducted, a bibliographic search for published articles that present beliefs, opinions, similarities, and differences regarding policies governing the sharing of clinical trial data. The second search analyzed the gray literature (non-peer-reviewed publications) to identify important data-sharing policies in selected biomedical journals, foundations, funding agencies, and other professional organizations.
A total of 471 articles were included after database search and screening, with 45 from the bibliographic search and 426 from the gray literature search. A total of 424 data-sharing policies were included. Fourteen of the 45 published articles from the bibliographic search (31.1%) discussed only advantages specific to data-sharing policies, 27 (27/45; 60%) discussed both advantages and disadvantages, and 4 (4/45; 8.9%) discussed only disadvantages specific. A total of 216 journals (of 270; 80%) specified a data-sharing policy provided by the journal itself. One hundred industry data-sharing policies were included, and 32 (32%) referenced a data-sharing policy on their website. One hundred and thirty-six (42%) organizations (of 327) specified a data-sharing policy.
We found many similarities listed as advantages to data-sharing and fewer disadvantages were discussed within the literature. Additionally, we found a wide variety of commonalities and differences-such as the lack of standardization between policies, and inadequately addressed details regarding the accessibility of research data-that exist in data-sharing policies endorsed by biomedical journals, funding agencies, and other professional organizations. Our study may not include information on all data sharing policies and our data is limited to the entities' descriptions of each policy.
确定生物医学期刊、资助机构及其他专业组织认可的临床试验数据共享政策的异同。此外，确定生物医学期刊发表的文章中所讨论的关于临床试验数据共享政策的观点和看法。
进行了两项检索，一项是文献检索，查找发表的关于临床试验数据共享政策的观点、看法、异同的文章。第二项检索分析灰色文献（非同行评审出版物），以确定选定的生物医学期刊、基金会、资助机构及其他专业组织的重要数据共享政策。
数据库检索和筛选后共纳入471篇文章，其中文献检索45篇，灰色文献检索426篇。共纳入424项数据共享政策。文献检索的45篇发表文章中，14篇（31.1%）仅讨论了数据共享政策的特定优势，27篇（27/45；60%）讨论了优势和劣势，4篇（4/45；8.9%）仅讨论了特定劣势。270种期刊中有216种（80%）规定了期刊自身提供的数据共享政策。纳入了100项行业数据共享政策，其中32项（32%）在其网站上提及了数据共享政策。327个组织中有136个（42%）规定了数据共享政策。
我们发现文献中列出的数据共享优势有许多相似之处，而讨论的劣势较少。此外，我们发现生物医学期刊、资助机构及其他专业组织认可的数据共享政策存在广泛的共性和差异，如政策之间缺乏标准化，以及研究数据可获取性的细节未得到充分解决。我们的研究可能未涵盖所有数据共享政策的信息，且我们的数据仅限于各实体对每项政策的描述。
