ArticleBMJ open2017
Sharing and reuse of individual participant data from clinical trials: principles and recommendations.
Article in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 105 papers, 6 of them syntheses that pooled 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.
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.
Who cites it
105 citing papers in PubMed, 6 syntheses or guidelines pooled it, 201 citations in OpenAlex.
- Pooled it
- Reducing self-harm in adolescents: the RISA-IPD comprehensive synopsis.Health technology assessment (Winchester, England) · 2026Pooled it
- Serum 25-hydroxyvitamin D threshold and risk of rickets in young children: a systematic review and individual participant data meta-analysis to inform the development of dietary requirements for vitamin D.European journal of nutrition · 2024Pooled it
- Causally Interpretable Meta-analysis: Application in Adolescent HIV Prevention.Prevention science : the official journal of the Society for Prevention Research · 2022Pooled it
- Individual participant data (IPD)-level meta-analysis of randomised controlled trials to estimate the vitamin D dietary requirements in dark-skinned individuals resident at high latitude.European journal of nutrition · 2022Pooled it
- Individual participant data (IPD)-level meta-analysis of randomised controlled trials with vitamin D-fortified foods to estimate Dietary Reference Values for vitamin D.European journal of nutrition · 2021Pooled it
- Clinical Implications of Body Mass Index in Metastatic Breast Cancer Patients Treated With Abemaciclib and Endocrine Therapy.Journal of the National Cancer Institute · 2021Trial
- Attitudes of Longitudinal Study Participants and Members of the Public Towards Data Sharing for Secondary Research: A Survey Based Approach.Journal of empirical research on human research ethics : JERHRE · 2026Article
- Ethical Considerations for Clinical Data Sharing in Craniofacial Research: Recommendations From a Multidisciplinary Working Group.The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association · 2026Article
- Enhanced Health Study Discoverability: Graph-Based Analysis Approach.JMIR medical informatics · 2026Article
- Inconsistent ethics reporting in individual participant data meta-analyses: a call for updating PRISMA and PRISMA-IPD.BMC medicine · 2026Article
- Facilitating access to clinical data from a randomized controlled trial of complex adaptive design.BMC research notes · 2026Article
- Low-intervention clinical trials in Spain: Do they progress?British journal of clinical pharmacology · 2026Article
- Review
- Unlocking the benefits of transparent and reusable science for climate risk management.Proceedings of the National Academy of Sciences of the United States of America · 2026Article
- Assessing realism of artificial intelligence-generated colorectal polyp images: International multicenter blinded reader study.Endoscopy international open · 2026Article
- Evolving roles of Data Coordinating Centers in multisite research: Challenges and adaptations from a rapid scoping review.Journal of clinical and translational science · 2026Review
- How to conduct an individual participant data meta-analysis in response to an emerging pathogen: Lessons learned from Zika and COVID-19.Research synthesis methods · 2026Review
- Independent researchers in east Asian surgical research: structural barriers and potential policy pathways.Frontiers in research metrics and analytics · 2026Article
- How does academia recognize the contribution of scientific data? Evidence from data contributors' authorship.Scientific data · 2025Article
45 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
41 authors at 20 institutions in 18 countries.
Funding
Abstract
objectivesWe examined major issues associated with sharing of individual clinical trial data and developed a consensus document on providing access to individual participant data from clinical trials, using a broad interdisciplinary approach. DESIGN AND
methodsThis was a consensus-building process among the members of a multistakeholder task force, involving a wide range of experts (researchers, patient representatives, methodologists, information technology experts, and representatives from funders, infrastructures and standards development organisations). An independent facilitator supported the process using the nominal group technique. The consensus was reached in a series of three workshops held over 1 year, supported by exchange of documents and teleconferences within focused subgroups when needed. This work was set within the Horizon 2020-funded project CORBEL (Coordinated Research Infrastructures Building Enduring Life-science Services) and coordinated by the European Clinical Research Infrastructure Network. Thus, the focus was on non-commercial trials and the perspective mainly European. OUTCOME: We developed principles and practical recommendations on how to share data from clinical trials.
resultsThe task force reached consensus on 10 principles and 50 recommendations, representing the fundamental requirements of any framework used for the sharing of clinical trials data. The document covers the following main areas: making data sharing a reality (eg, cultural change, academic incentives, funding), consent for data sharing, protection of trial participants (eg, de-identification), data standards, rights, types and management of access (eg, data request and access models), data management and repositories, discoverability, and metadata.
conclusionsThe adoption of the recommendations in this document would help to promote and support data sharing and reuse among researchers, adequately inform trial participants and protect their rights, and provide effective and efficient systems for preparing, storing and accessing data. The recommendations now need to be implemented and tested in practice. Further work needs to be done to integrate these proposals with those from other geographical areas and other academic domains.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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 OpenQuestion graph.