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Author: admin_blackspike

iDx Lung team taking blood sample from patient

The Wessex Secure Data Environment (SDE) is playing a key role in the ‘iDx Lung’ study, a collaborative research project spearheaded by the Southampton Clinical Trials Unit, based at the University of Southampton, and the iDx Lung Consortium which recruited 7000 participants. This exciting study seeks to revolutionise early lung cancer detection through comprehensive data analysis.

Using the Wessex SDE’s sophisticated data handling capabilities, the study combines data from analysing blood and nasal swab tests, and detailed patient background information. Researchers look at this data for clues to help find lung cancer at an earlier stage, potentially increasing survival rates and improving care.

The study has already completed its first phase, which did not use the Wessex SDE. In its next phase, iDx Lung will expand to  further trial sites across the UK, recruiting a further cohort of participants from across the country.

To be able to find patterns and make discoveries from all this data researchers need to combine it. More people and more places make this a really complex job. Without the support of the Wessex SDE this would be a huge challenge. With the SDE it can be done quickly and securely, with the NHS in full control of how patient health data is used.

The next phase of the study is now in  development. For more information or to learn how to get involved, please contact the Southampton Clinical Trials Unit (here).

 

 

DNA

The ‘Cancer Genomics’ project is a joint initiative with Sarah Ennis, Professor of Genomics at the University of Southampton and Research Director at the Central & South Genomic Medicine Service. This project will use Wessex SDE’s robust data infrastructure to link high-quality genomic data with other medical information about patients’ cancer journeys.

This integration allows for a more comprehensive understanding of cancer genomics, enabling researchers to identify genetic markers that are crucial in the development and progression of cancer.

Increasing the amount of data genetic screened will better enable matching of exact cancer variants to the drugs that best target them, speeding up the time it takes to find the most effective treatment for patients. This can help save lives.

Critical to the success of the project will be the ability to link together data from several different places and analyse it in a secure environment, whilst carefully protecting patient privacy and maintaining high levels of security.

The project is currently in development and no data will be transferred to the Wessex SDE or analyses undertaken until ethics and other approvals are secured.

Good governance

We are working within a highly regulated environment. All SDEs must comply with existing legal frameworks and NHS legislation to keep data safe and ensure it is used correctly.

The UK has high data protection standards to control how personal information is used. These include:

The Wessex Secure Data Environment established a Programme Board to decide on, and oversee, the work of the SDE. They are overseen by an Executive Sponsor Group, from the the Integrated Care Boards of Dorset, and Hampshire and the Isle of Wight.

The Wessex SDE also adopts the University Hospital Southampton NHS Foundation Trust policies and operational procedures. While this is an interim measure it ensures that we maintain the highest standards as expected from an NHS body.

Throughout the design phase of the SDE, we will be working with people, patients, and professionals in Wessex to co-design the effective and independent governance. This is being developed in the context of national policy, to ensure that meets the needs and expectations of all partners in our region, and the wider NHS Research SDE Network.

Green Light

Wessex Secure Data Environment (SDE) has successfully obtained approvals from the NHS Health Research Authority (HRA), marking a significant step in ethical and legal compliance.  

The Research Ethics Committee has granted ethical approval for the project. Whilst the HRA’s Confidentiality Advisory Group has given the Wessex SDE permission to access confidential patient information without individual consent (this permission is known as a Section 251 notice).  

The SDE will use this Section 251 permission only to link together data from different places. This is crucial for creating the big datasets that researchers need. Personal information is always removed or disguised before it is made available to researchers. Researchers never see confidential patient information.  

This milestone not only underscores the Wessex SDE’s commitment to upholding the highest standards of data protection and privacy but also paves the way for groundbreaking research that can significantly impact patient care and health outcomes. 

CAG Reference: 24/CAG/0013: CAG register – April 2013 onward approved research applications line 886

REC Reference: 24/NE/0028

For more information on the HRA approval process please see their website here.