BMC Res Notes. 2026 Jul 12. doi: 10.1186/s13104-026-07888-2. Online ahead of print.
ABSTRACT
OBJECTIVES: To 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.
PMID:42437936 | DOI:10.1186/s13104-026-07888-2
