Evaluation of Data Sharing After Implementation of the International Committee of Medical Journal Editors Data Sharing Statement Requirement
| Autor: | Yan Min, John P. A. Ioannidis, John A. Borghi, Valentin Danchev, Michael Baiocchi |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Clinical Trials as Topic Cross-sectional study business.industry Information Dissemination MEDLINE General Medicine Medical writing Medical Writing Data sharing Clinical trial Cross-Sectional Studies Family medicine medicine Humans Observational study Data set (IBM mainframe) Periodicals as Topic business Editorial Policies |
| Zdroj: | JAMA network open. 4(1) |
| ISSN: | 2574-3805 |
| Popis: | Importance 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. Objective To evaluate the implementation of the ICMJE DSS requirement in 3 leading medical journals:JAMA,Lancet, andNew England Journal of Medicine(NEJM). Design, Setting, and Participants This is a cross-sectional study of clinical trial reports published as articles inJAMA,Lancet, andNEJMbetween 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 inJAMA(112 trials),Lancet(147 trials), andNEJM(228 trials). Two reviewers evaluated each of the 487 articles independently. Exposure Publication of clinical trial reports in an ICMJE medical journal requiring a DSS. Main Outcomes and Measures 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. Results 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. Conclusions and Relevance Most trials published inJAMA,Lancet, andNEJMafter 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. |
| Databáze: | OpenAIRE |
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