Evaluation of Data Sharing After Implementation of the International Committee of Medical Journal Editors Data Sharing Statement Requirement.
Evaluation of Data Sharing After Implementation of the International Committee of Medical Journal Editors Data Sharing Statement Requirement.
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DOI：
10.1001/jamanetworkopen.2020.33972
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发表时间：
2021-01-04
影响因子：
13.8
通讯作者：
Ioannidis JPA
中科院分区：
文献类型：
--
作者：
Danchev V;Min Y;Borghi J;Baiocchi M;Ioannidis JPA
在国际医学期刊编辑委员会数据共享声明要求实施后，医学期刊临床试验数据的申报和实际共享率如何？在这项对487项发表在《美国医学会杂志》、《柳叶刀》和《新英格兰医学杂志》上的临床试验的横断面研究中，334篇文章（68.6%）宣称数据共享。只有2（0.6%）个人参与者数据集实际上被去识别并在期刊网站上公开，在89篇声明个人参与者数据将存储在安全存储库中的文章中，截至2020年4月10日，只有17篇文章的数据在各自的存储库中找到。这些发现表明，临床试验数据的公开共享与实际共享之间存在很大差距。这项横断面研究评估了国际医学期刊编辑委员会（ICMJE）数据共享声明要求在3种主要医学期刊中的实施情况。负责任地共享临床研究中的个人参与者数据（IPD）的好处是众所周知的，但利益相关者往往不同意如何将这些好处与隐私风险，成本以及临床试验者和申办者的激励措施相结合。国际医学期刊编辑委员会（ICMJE）要求自2018年7月1日起报告临床试验的提交材料提供数据共享声明（DSS）。所需的DSS提供了一个窗口，可以了解试验参与者和申办者之间当前的数据共享率、实践和规范。评估3种主要医学期刊（JAMA、Lancet和新英格兰医学杂志（NEJM））中ICMJE DSS要求的实施情况。这是一项对2018年7月1日至2020年4月4日期间在JAMA，Lancet和NEJM上发表的临床试验报告进行的横断面研究。排除了不符合DSS条件的文章，包括观察性研究和信件或通信。MEDLINE/PubMed检索在JAMA（112项试验）、Lancet（147项试验）和NEJM（228项试验）中确定了487项合格的临床试验。两名评审员独立评估了487篇文章中的每一篇。在需要DSS的ICMJE医学期刊上发表临床试验报告。研究的主要成果是数据库中宣布的数据可用性和实际数据可用性。其他获得的结果是数据类型、访问以及数据可用或不可用的条件和原因。审查了与供资来源的联系。487篇文章中共有334篇（68.6%; 95%CI，64%-73%）声明了数据共享，非行业NIH资助的试验显示出最高的数据共享率（89%; 95%CI，80%-98%），行业资助的试验最低（61%; 95%CI，54%-68%）。然而，截至2020年4月10日，只有2个IPD集（0.6%; 95% CI，0.0%-1.5%）实际上被去识别并公开。其余的被认为可以通过请求作者（334篇文章中的143篇[42.8%]），存储库（334篇文章中的89篇[26.6%]）和公司（334篇文章中的78篇[23.4%]）访问。在89篇声明IPD将存储在存储库中的文章中，只有17篇（19.1%）存储了数据，主要是因为禁运和监管批准。47.3%的数据共享文章（334篇中的158篇）设置了禁运，其中一半的时间超过1年或未指明。在ICMJE政策实施后，大多数发表在JAMA，Lancet和NEJM上的试验都宣布他们打算提供临床数据。然而，申报的数据共享与实际的数据共享之间存在很大差距。为了提高透明度和数据重用，期刊应促进使用数据集位置的唯一指针，以及禁运期和访问要求的标准化选择。
What are the rates of declared and actual sharing of clinical trial data after the medical journals’ implementation of the International Committee of Medical Journal Editors data sharing statement requirement? In this cross-sectional study of 487 clinical trials published in JAMA, Lancet, and New England Journal of Medicine, 334 articles (68.6%) declared data sharing. Only 2 (0.6%) individual-participant data sets were actually deidentified and publicly available on a journal website, and among the 89 articles declaring that individual-participant data would be stored in secure repositories, data from only 17 articles were found in the respective repositories as of April 10, 2020. These findings suggest that there is a wide gap between declared and actual sharing of clinical trial data. This cross-sectional study evaluates the implementation of the International Committee of Medical Journal Editors (ICMJE) data sharing statement requirement in 3 leading medical journals. The benefits of responsible sharing of individual-participant data (IPD) from clinical studies are well recognized, but stakeholders often disagree on how to align those benefits with privacy risks, costs, and incentives for clinical trialists and sponsors. The International Committee of Medical Journal Editors (ICMJE) required a data sharing statement (DSS) from submissions reporting clinical trials effective July 1, 2018. The required DSSs provide a window into current data sharing rates, practices, and norms among trialists and sponsors. To evaluate the implementation of the ICMJE DSS requirement in 3 leading medical journals: JAMA, Lancet, and New England Journal of Medicine (NEJM). This is a cross-sectional study of clinical trial reports published as articles in JAMA, Lancet, and NEJM between July 1, 2018, and April 4, 2020. Articles not eligible for DSS, including observational studies and letters or correspondence, were excluded. A MEDLINE/PubMed search identified 487 eligible clinical trials in JAMA (112 trials), Lancet (147 trials), and NEJM (228 trials). Two reviewers evaluated each of the 487 articles independently. Publication of clinical trial reports in an ICMJE medical journal requiring a DSS. The primary outcomes of the study were declared data availability and actual data availability in repositories. Other captured outcomes were data type, access, and conditions and reasons for data availability or unavailability. Associations with funding sources were examined. A total of 334 of 487 articles (68.6%; 95% CI, 64%-73%) declared data sharing, with nonindustry NIH-funded trials exhibiting the highest rates of declared data sharing (89%; 95% CI, 80%-98%) and industry-funded trials the lowest (61%; 95% CI, 54%-68%). However, only 2 IPD sets (0.6%; 95% CI, 0.0%-1.5%) were actually deidentified and publicly available as of April 10, 2020. The remaining were supposedly accessible via request to authors (143 of 334 articles [42.8%]), repository (89 of 334 articles [26.6%]), and company (78 of 334 articles [23.4%]). Among the 89 articles declaring that IPD would be stored in repositories, only 17 (19.1%) deposited data, mostly because of embargo and regulatory approval. Embargo was set in 47.3% of data-sharing articles (158 of 334), and in half of them the period exceeded 1 year or was unspecified. Most trials published in JAMA, Lancet, and NEJM after the implementation of the ICMJE policy declared their intent to make clinical data available. However, a wide gap between declared and actual data sharing exists. To improve transparency and data reuse, journals should promote the use of unique pointers to data set location and standardized choices for embargo periods and access requirements.
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影响因子：
3.1
作者：
Anderson, Melissa S.;Ronning, Emily A.;Martinson, Brian C.
通讯作者：
Martinson, Brian C.
DOI：
10.1056/nejmsa1603542
发表时间：
2017-05-11
期刊：
The New England journal of medicine
影响因子：
--
作者：
Coady SA;Mensah GA;Wagner EL;Goldfarb ME;Hitchcock DM;Giffen CA
通讯作者：
Giffen CA
影响因子：
7.7
作者：
Danchev, Valentin;Rzhetsky, Andrey;Evans, James A.
通讯作者：
Evans, James A.
影响因子：
9.8
作者：
Moher D;Naudet F;Cristea IA;Miedema F;Ioannidis JPA;Goodman SN
通讯作者：
Goodman SN
影响因子：
11.1
作者：
Ewers M;Biechele G;Suárez-Calvet M;Sacher C;Blume T;Morenas-Rodriguez E;Deming Y;Piccio L;Cruchaga C;Kleinberger G;Shaw L;Trojanowski JQ;Herms J;Dichgans M;Alzheimer's Disease Neuroimaging Initiative (ADNI);Brendel M;Haass C;Franzmeier N
通讯作者：
Franzmeier N