Data sharing policies, requirements, and support from public and private clinical trial sponsors: a survey on top sponsors of clinical trials in Europe
Abstract
Objectives: This study aimed to map the presence, public availability, and content of clinical trial data sharing policies, data management and sharing plans, and data use agreements among the most prolific public and private clinical trial sponsors operating in Europe. Study design and setting: We included organization-level documents describing approaches to clinical trial data sharing or data management from the top 20 public and top 20 private sponsors ranked by the number of trials registered in the European Union (EU) Clinical Trials Information System. Eligible materials comprised publicly available or sponsor-shared policies, guidelines, statements, templates, and agreements relevant to clinical trial data sharing or management. Evidence was identified through systematic searches of sponsors' public websites, structured Google searches, and major data management plan platforms, complemented by direct contact with sponsors to verify findings and request missing documentation. All sources were archived and cataloged. Two reviewers independently extracted data using a structured form, capturing the existence, accessibility, and content of data sharing policies, data management and sharing plans, and data use agreements. Quantitative data were summarized descriptively, and a noninterpretive descriptive content analysis was conducted to characterize recurring policy elements and areas of heterogeneity. Results: Among 40 sponsors, private sponsors were substantially more likely than public sponsors to make trial-specific data sharing policies and data use agreements publicly accessible, often via established data sharing platforms. Public sponsors more frequently referenced data management and sharing plans, but these were heterogeneous in scope and often embedded within broader institutional governance documents rather than tailored to clinical trials. Across sectors, General Data Protection Regulation compliance, data protection, and legal safeguards were emphasized, while operational aspects such as dataset readiness, review criteria, and downstream responsibilities varied widely. Overall response rate to sponsor verification was 37.5%. Conclusion: Clinical trial data sharing governance in the EU shows a marked sectoral imbalance among the top sponsors. Private sponsors tend to provide more detailed and operationally explicit documentation, whereas public sponsors often articulate high-level commitments without trial-specific guidance. Greater clarity and standardization, particularly among public sponsors, could improve transparency and facilitate responsible data reuse, while remaining compatible with General Data Protection Regulation requirements.
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BibTeX
@article{tai2026data,
title = {{Data sharing policies, requirements, and support from public and private clinical trial sponsors: a survey on top sponsors of clinical trials in Europe}},
author = {Ka Hin Tai and Giulia Varvarà and Emma Escoffier and Ulrich Mansmann and Nicholas J Devito and Anna Catharina Vieira Armond and Florian Naudet},
journal = {Journal of Clinical Epidemiology},
year = {2026},
month = oct,
doi = {10.1016/j.jclinepi.2026.112452},
url = {https://hal.science/hal-05748866v1},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Data sharing policies, requirements, and support from public and private clinical trial sponsors: a survey on top sponsors of clinical trials in Europe
AU - Ka Hin Tai
AU - Giulia Varvarà
AU - Emma Escoffier
AU - Ulrich Mansmann
AU - Nicholas J Devito
AU - Anna Catharina Vieira Armond
AU - Florian Naudet
PY - 2026
DA - 2026/10/23
JO - Journal of Clinical Epidemiology
DO - 10.1016/j.jclinepi.2026.112452
UR - https://hal.science/hal-05748866v1
AB - Objectives: This study aimed to map the presence, public availability, and content of clinical trial data sharing policies, data management and sharing plans, and data use agreements among the most prolific public and private clinical trial sponsors operating in Europe. Study design and setting: We included organization-level documents describing approaches to clinical trial data sharing or data management from the top 20 public and top 20 private sponsors ranked by the number of trials registered in the European Union (EU) Clinical Trials Information System. Eligible materials comprised publicly available or sponsor-shared policies, guidelines, statements, templates, and agreements relevant to clinical trial data sharing or management. Evidence was identified through systematic searches of sponsors' public websites, structured Google searches, and major data management plan platforms, complemented by direct contact with sponsors to verify findings and request missing documentation. All sources were archived and cataloged. Two reviewers independently extracted data using a structured form, capturing the existence, accessibility, and content of data sharing policies, data management and sharing plans, and data use agreements. Quantitative data were summarized descriptively, and a noninterpretive descriptive content analysis was conducted to characterize recurring policy elements and areas of heterogeneity. Results: Among 40 sponsors, private sponsors were substantially more likely than public sponsors to make trial-specific data sharing policies and data use agreements publicly accessible, often via established data sharing platforms. Public sponsors more frequently referenced data management and sharing plans, but these were heterogeneous in scope and often embedded within broader institutional governance documents rather than tailored to clinical trials. Across sectors, General Data Protection Regulation compliance, data protection, and legal safeguards were emphasized, while operational aspects such as dataset readiness, review criteria, and downstream responsibilities varied widely. Overall response rate to sponsor verification was 37.5%. Conclusion: Clinical trial data sharing governance in the EU shows a marked sectoral imbalance among the top sponsors. Private sponsors tend to provide more detailed and operationally explicit documentation, whereas public sponsors often articulate high-level commitments without trial-specific guidance. Greater clarity and standardization, particularly among public sponsors, could improve transparency and facilitate responsible data reuse, while remaining compatible with General Data Protection Regulation requirements.
SN - 0895-4356
SN - 1878-5921
ER -