ArticleTrials2018
Data sharing in clinical trials - practical guidance on anonymising trial datasets.
Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis 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
24 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- Repurposing anti-retroviral drugs to treat NF2-related tumours: a protocol for a phase 0 trial (RETREAT).BMJ open · 2026Article
- Article
- A survey on UK researchers' views regarding their experiences with the de-identification, anonymisation, release methods and re-identification risk estimation for clinical trial datasets.Clinical trials (London, England) · 2025Article
- Sharing sensitive data in life sciences: an overview of centralized and federated approaches.Briefings in bioinformatics · 2024Review
- The Costs of Anonymization: Case Study Using Clinical Data.Journal of medical Internet research · 2024Article
- Article
- A 10-year update to the principles for clinical trial data sharing by pharmaceutical companies: perspectives based on a decade of literature and policies.BMC medicine · 2023Article
- Article
- Ten simple rules for designing and conducting undergraduate replication projects.PLoS computational biology · 2023Article
- Returning study results to research participants: Data access, format, and sharing preferences.International journal of medical informatics · 2023Article
- Article
- Qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance.HRB open research · 2023Article
- Reporting and transparent research practices in sports medicine and orthopaedic clinical trials: a meta-research study.BMJ open · 2022Article
- Current recommendations/practices for anonymising data from clinical trials in order to make it available for sharing: A scoping review.Clinical trials (London, England) · 2022Article
- Writing up your clinical trial report for a scientific journal: the REPORT trial guide for effective and transparent research reporting without spin.British journal of sports medicine · 2022Review
- Attenuated androgen discontinuation in patients with hereditary angioedema: a commented case series.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2022Article
- Transfer, Collection and Organisation of Electrophysiological and Imaging Data for Multicentre Studies.Neuroinformatics · 2021Article
- A study protocol of qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance.HRB open research · 2021Article
- Considerations for an integrated population health databank in Africa: lessons from global best practices.Wellcome open research · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThere is an increasing demand by non-commercial funders that trialists should provide access to trial data once the primary analysis is completed. This has to take into account concerns about identifying individual trial participants, and the legal and regulatory requirements.
methodsUsing the good practice guideline laid out by the work funded by the Medical Research Council Hubs for Trials Methodology Research (MRC HTMR), we anonymised a dataset from a recently completed trial. Using this example, we present practical guidance on how to anonymise a dataset, and describe rules that could be used on other trial datasets. We describe how these might differ if the trial was to be made freely available to all, or if the data could only be accessed with specific permission and data usage agreements in place.
resultsFollowing the good practice guidelines, we successfully created a controlled access model for trial data sharing. The data were assessed on a case-by-case basis classifying variables as direct, indirect and superfluous identifiers with differing methods of anonymisation assigned depending on the type of identifier. A final dataset was created and checks of the anonymised dataset were applied. Lastly, a procedure for release of the data was implemented to complete the process.
conclusionsWe have implemented a practical solution to the data anonymisation process resulting in a bespoke anonymised dataset for a recently completed trial. We have gained useful learnings in terms of efficiency of the process going forward, the need to balance anonymity with data utilisation and future work that should be undertaken.
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.