ArticleBMC research notes2026
Facilitating access to clinical data from a randomized controlled trial of complex adaptive design.
Article in BMC research notes, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
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
Abstract
objectivesTo describe the steps taken in the creation of a Data Pack containing clinical data from the FOCUS4 randomized controlled trial in colorectal cancer, representing a case study of clinical trial data access and sharing. DATA DESCRIPTION: The FOCUS4 trial recruited 1434 metastatic colorectal cancer patients between January 2017 and March 2020 from 94 sites across the United Kingdom (UK). The trial used an adaptive "umbrella" design, in which tumour samples from recruited patients underwent molecular testing, the results of which determined into which of multiple parallel randomized allocations they would be eligible to enter. Overall, 361 patients were successfully randomised into one of four "sub-trials": FOCUS4-B (6 patients), FOCUS4-C (67 patients), FOCUS4-D (32 patients) and FOCUS4-N (254 patients). After the trial had concluded, we created a Data Pack containing pseudonymised data organised into registration data and follow up data, marked case report forms (CRFs), data dictionary, study protocols and statistical analysis plan. This will help researchers to easily understand the datasets for study replication, further research analysis or to integrate with other existing datasets or repositories.
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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.