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Facilitating access to clinical data from a randomized controlled trial of complex adaptive design
Victor Olago1, Victoria Yorke-Edwards2, Louise C Brown3
1Centre for Advanced Research Computing, UCL, 90 High Holborn 1st Floor, London, WC1V 6LJ, UK. v.olago@ucl.ac.uk.
A Data Pack was created from the FOCUS4 colorectal cancer trial, organizing clinical data for easier research access and sharing. This facilitates study replication and integration with other datasets.
Area of Science:
- Oncology
- Clinical Trials
- Data Science
Background:
- The FOCUS4 trial investigated metastatic colorectal cancer treatments using an adaptive umbrella design.
- Molecular testing guided patient allocation into parallel sub-trials based on tumor characteristics.
Purpose of the Study:
- To detail the creation of a comprehensive Data Pack from the FOCUS4 clinical trial data.
- To serve as a case study for clinical trial data access and sharing practices.
Main Methods:
- Recruited 1434 metastatic colorectal cancer patients across 94 UK sites (Jan 2017-Mar 2020).
- Utilized an adaptive umbrella design with molecular testing for patient stratification.
- Organized pseudonymised data into registration, follow-up data, CRFs, data dictionary, protocols, and SAP into a Data Pack.
Main Results:
- Successfully randomized 361 patients into four sub-trials (FOCUS4-B, -C, -D, -N).
- Developed a Data Pack containing pseudonymised clinical trial data and associated documentation.
Conclusions:
- The created Data Pack enhances accessibility for researchers.
- Facilitates study replication, further analysis, and data integration with other repositories.
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