ArticleTrials2021
Accessing routinely collected health data to improve clinical trials: recent experience of access.
Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 3 of them syntheses that pooled it.
What it found
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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
19 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- The reporting of health systems data use in primary results publications of clinical trials: a systematic review.Trials · 2025Pooled it
- Evaluation of venous thromboembolism risk assessment models for hospital inpatients: the VTEAM evidence synthesis.Health technology assessment (Winchester, England) · 2024Pooled it
- A Hybrid Architecture (CO-CONNECT) to Facilitate Rapid Discovery and Access to Data Across the United Kingdom in Response to the COVID-19 Pandemic: Development Study.Journal of medical Internet research · 2022Pooled it
- Trial
- Embedding the public voice in clinical trials: developing public-informed training for patient data research.Research involvement and engagement · 2026Article
- Phenobarbital as an Adjuvant to benzodiazepines when compared to Single-agent benzodiazepine Treatment (usual care) for Alcohol withdrawal syndrome in the intensive care unit (PASTA): a study protocol.Pilot and feasibility studies · 2026Article
- Article
- Linkage of Clinical Trial Data to Routinely Collected Data Sources: A Scoping Review.JAMA network open · 2025Article
- Exploring the implementation of a data trust committee: a qualitative evaluation of processes and practices.Research involvement and engagement · 2025Article
- Prevalence and incidence of transfusion-transmissible infections among blood donors in Malawi: A population-level study.Transfusion medicine (Oxford, England) · 2023Article
- Article
- Leveraging Virtual Technology to Conduct Clinical Trials in Inflammatory Bowel Disease.Gastroenterology & hepatology · 2023Article
- Healthcare systems data in the context of clinical trials - A comparison of cardiovascular data from a clinical trial dataset with routinely collected data.Contemporary clinical trials · 2023Article
- Article
- Observational
- Making administrative healthcare systems clinical data the future of clinical trials: lessons from BladderPath.BMJ oncology · 2023Article
- Article
- Article
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
backgroundRoutinely collected electronic health records (EHRs) have the potential to enhance randomised controlled trials (RCTs) by facilitating recruitment and follow-up. Despite this, current EHR use is minimal in UK RCTs, in part due to ongoing concerns about the utility (reliability, completeness, accuracy) and accessibility of the data. The aim of this manuscript is to document the process, timelines and challenges of the application process to help improve the service both for the applicants and data holders.
methodsThis is a qualitative paper providing a descriptive narrative from one UK clinical trials unit (MRC CTU at UCL) on the experience of two trial teams' application process to access data from three large English national datasets: National Cancer Registration and Analysis Service (NCRAS), National Institute for Cardiovascular Outcomes Research (NICOR) and NHS Digital to establish themes for discussion. The underpinning reason for applying for the data was to compare EHRs with data collected through case report forms in two RCTs, Add-Aspirin (ISRCTN 74358648) and PATCH (ISRCTN 70406718).
resultsThe Add-Aspirin trial, which had a pre-planned embedded sub-study to assess EHR, received data from NCRAS 13 months after the first application. In the PATCH trial, the decision to request data was made whilst the trial was recruiting. The study received data after 8 months from NICOR and 15 months for NHS Digital following final application submission. This concluded in May 2020. Prior to application submission, significant time and effort was needed particularly in relation to the PATCH trial where negotiations over consent and data linkage took many years.
conclusionsOur experience demonstrates that data access can be a prolonged and complex process. This is compounded if multiple data sources are required for the same project. This needs to be factored in when planning to use EHR within RCTs and is best considered prior to conception of the trial. Data holders and researchers are endeavouring to simplify and streamline the application process so that the potential of EHR can be realised for clinical trials.
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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.