Evidence map›Paper›PMID 40890807›Full record

ArticleBMC medicine2025

Practice of data sharing plans in clinical trial registrations and concordance between registered and published data sharing plans: a cross-sectional study.

Jingyi Zhang, Barbara E Bierer, Harriette G C Van Spall, Yingxin Liu, Xuerui Bai, Lehana Thabane, Gregory Y H Lip, Xin Sun, David Moher, Guowei Li

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In one paragraph

Article in BMC medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Jingyi ZhangCenter for Clinical Epidemiology and Methodology (CCEM), The Affiliated Guangdong Second Provincial General Hospital of Jinan University, Guangzhou, Guangdong, 510317, China.
Barbara E BiererDepartment of Medicine, Harvard Medical School, Boston, MA, USA.
Harriette G C Van SpallDepartment of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
Yingxin LiuCenter for Clinical Epidemiology and Methodology (CCEM), The Affiliated Guangdong Second Provincial General Hospital of Jinan University, Guangzhou, Guangdong, 510317, China.
Xuerui BaiDepartment of Epidemiology, School of Medicine, Jinan University, Guangzhou, China.
Lehana ThabaneDepartment of Health Research Methods, Evidence, and Impact (HEI), McMaster University, Hamilton, ON, Canada.
Gregory Y H LipLiverpool Centre for Cardiovascular Sciences at University of Liverpool, Liverpool Heart & Chest Hospital, Liverpool John Moores University, Liverpool, UK.
Xin SunChinese Evidence-Based Medicine Center and Cochrane China Center, West China Hospital, Sichuan University, Chengdu, China.
David MoherSchool of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.
Guowei LiCenter for Clinical Epidemiology and Methodology (CCEM), The Affiliated Guangdong Second Provincial General Hospital of Jinan University, Guangzhou, Guangdong, 510317, China. ligw@gd2h.org.cn.

Funding

National Natural Science Foundation of China 82473612Natural Science Foundation of Guangdong Province of China 2025A1515010779Science Foundation of Guangdong Second Provincial General hospital TJGC-202506Science Foundation of Guangdong Second Provincial General Hospital YY2018-002Young Top Talent Project in Special Support Plan for Training High-level Talents in Guangdong 0720240244
6 · The paper itself

Abstract

backgroundThe International Committee of Medical Journal Editors (ICMJE) recommends that trial authors must specify data sharing plans when trials are registered and published, yet this uptake remains unclear. We aimed to assess the practice of data sharing plans in trial registration platforms and the concordance between registered and published data sharing plans.

methodsWe included clinical trials published between 2021 and 2023 in six high-profile journals (The Lancet, The New England Journal of Medicine, JAMA, BMJ, JAMA Internal Medicine, and Annals of Internal Medicine) that enrolled participants no earlier than 2019 and registered on clinical trial platforms. One study outcome was data sharing plans in the trial registration platform, where trials clearly responding a "yes" to "Plan to share" were considered as planning to share data (including study protocols, statistical analysis plans, analytic codes, and individual participant data). The concordance between registered and published plans to share data was also assessed, which included plans to either share data (Yes/Yes) and not to share data (No/No) in both registration and publications. Univariate analyses were used to assess associations between trial characteristics and registered plans to share data and between trial characteristics and concordance.

resultsOf the 383 included registration IDs, only 44.6% (171/383) planned to share data in registration. Trials with drug versus non-drug interventions had increased odds of registering plans to share data (OR = 2.71, 95% CI: 1.63, 4.63). There were seven trial publications, each pooling two trials and having two registration IDs. We selected the registration IDs with a later start date, resulting in 376 trial publications for concordance assessment. Over half (216/376, 57.4%) had discordance between registration and publications. COVID-19-related trials were associated with decreased odds of data sharing concordance (OR = 0.59, 95% CI: 0.37, 0.91). Additionally, significant discordance was consistently found in statistical analysis plans or study protocols, analytic codes, and individual participant data.

conclusionsMost registered trials do not specify plans to share data. More than half of published trials have data sharing discordance between registration and publication. Efforts are required to improve the reporting and reliability of plans to share clinical trial data.

trial registrationThis study was registered on the Open Science Framework ( https://osf.io/k6etb ).

Indexed as

Clinical Trials as TopicInformation DisseminationRegistriesCross-Sectional StudiesHumansClinical trialData sharingPlan to share dataTrial publicationTrial registration

Identifiers

PMID40890807
PMCPMC12403310

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.