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Objectives <p>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.</p> Data description <p>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.</p>

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Facilitating access to clinical data from a randomized controlled trial of complex adaptive design

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年7月12日

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  • Victor Olago,
  • Victoria Yorke-Edwards,
  • Louise C. Brown,
  • Matt Sydes,
  • Tim Maughan,
  • David Fisher

摘要

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.