SynthesisTrials2020
Access to routinely collected health data for clinical trials - review of successful data requests to UK registries.
Synthesis in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 2 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
27 citing papers in PubMed, 2 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
- Equitable inclusion of patients with cancer on the palliative care register: a systematic review in primary care.The British journal of general practice : the journal of the Royal College of General Practitioners · 2025Pooled it
- Agreement and utility between registry and trial mortality data - a data utility comparison in the BOSS trial.Trials · 2026Trial
- Trial
- Reporting of Cohort and Routinely Collected Data in Randomised Controlled Trial Protocols (SPIRIT-ROUTINE): extension checklist with explanation and elaboration.BMJ (Clinical research ed.) · 2026Article
- Article
- Agreement and utility of coded primary and secondary care data for long-term follow-up of clinical trial outcomes.BMC medical research methodology · 2025Article
- Potential for advances in data linkage and data science to support injury prevention research.Injury prevention : journal of the International Society for Child and Adolescent Injury Prevention · 2024Article
- Use cases of registry-based randomized controlled trials-A review of the registries' contributions and constraints.Clinical and translational science · 2024Review
- The use of linked administrative data in Australian randomised controlled trials: A scoping review.Clinical trials (London, England) · 2024Article
- Navigating the complexities of drug development for inflammatory bowel disease.Nature reviews. Drug discovery · 2024Review
- Using healthcare systems data for outcomes in clinical trials: issues to consider at the design stage.Trials · 2024Article
- The use of healthcare systems data for RCTs.Trials · 2024Article
- Article
- Leveraging Virtual Technology to Conduct Clinical Trials in Inflammatory Bowel Disease.Gastroenterology & hepatology · 2023Article
- Electronic health records to capture primary outcome measures: two case studies in HIV prevention research.Trials · 2023Article
- Article
- Making administrative healthcare systems clinical data the future of clinical trials: lessons from BladderPath.BMJ oncology · 2023Article
- Data provenance and integrity of health-care systems data for clinical trials.The Lancet. Digital health · 2022Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
Abstract
backgroundClinical trials generally each collect their own data despite routinely collected health data (RCHD) increasing in quality and breadth. Our aim is to quantify UK-based randomised controlled trials (RCTs) accessing RCHD for participant data, characterise how these data are used and thereby recommend how more trials could use RCHD.
methodsWe conducted a systematic review of RCTs accessing RCHD from at least one registry in the UK between 2013 and 2018 for the purposes of informing or supplementing participant data. A list of all registries holding RCHD in the UK was compiled. In cases where registries published release registers, these were searched for RCTs accessing RCHD. Where no release register was available, registries were contacted to request a list of RCTs. For each identified RCT, information was collected from all publicly available sources (release registers, websites, protocol etc.). The search and data extraction were undertaken between January and May 2019.
resultsWe identified 160 RCTs accessing RCHD between 2013 and 2018 from a total of 22 registries; this corresponds to only a very small proportion of all UK RCTs (about 3%). RCTs accessing RCHD were generally large (median sample size 1590), commonly evaluating treatments for cancer or cardiovascular disease. Most of the included RCTs accessed RCHD from NHS Digital (68%), and the most frequently accessed datasets were mortality (76%) and hospital visits (55%). RCHD was used to inform the primary trial (82%) and long-term follow-up (57%). There was substantial variation in how RCTs used RCHD to inform participant outcome measures. A limitation was the lack of information and transparency from registries and RCTs with respect to which datasets have been accessed and for what purposes.
conclusionsIn the last five years, only a small minority of UK-based RCTs have accessed RCHD to inform participant data. We ask for improved accessibility, confirmed data quality and joined-up thinking between the registries and the regulatory authorities.
trial registrationPROSPERO CRD42019123088.
Indexed as
Identifiers
What Socratic 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 Socratic graph.