Information for Patients and the Public

Medical research is important to the NHS and is beneficial to everyone. This is true whether people are fit and healthy or have an illness or condition. Research helps the NHS to understand the causes, prevention and treatment of diseases and medical conditions, improving the care of patients.

Whenever you use an NHS service, your electronic health records are updated. These records contain important clinical data – known as Real World Data – which is vital for medical research.  

The Real World Data often required for medical research does not need information which identifies you – such as your name or address – but information about the health, care, treatments and medications of multiple individuals combined together.  As a result, the NHS can partner with a number of organisations, including Arcturis, to allow ethical, privacy-protecting access to these data for research. 

Arcturis develops partnerships with NHS organisations. These NHS organisations extract and combine clinical data into research datasets and make them accessible to Arcturis in a way that protects patient privacy, through a process called anonymisation. In following this process, NHS organisations commit to sharing no Confidential Patient Information with Arcturis.    

In collaboration with pharmaceutical, academic and NHS research clients in the UK and around the world, Arcturis then applies traditional and innovative medical statistics, machine learning and data science approaches to deliver the research findings and insights – known as Real World Evidence – needed to advance patient treatment and care.   

This method of accessing and analysing anonymised clinical data for medical research is operated as the Arcturis Real World Data Network. 

Arcturis ensures it’s NHS partner organisations benefit from being part of the Real World Data Network. Arcturis provides grant funding to support the preparation and access to anonymised clinical data. They also receive a share of revenue generated from the research undertaken by Arcturis for its clients.   

Clients are not permitted access to anonymised clinical data made available to the Real World Data Network. Instead, Arcturis works carefully with clients to co-develop research proposals. Highly trained Arcturis researchers then analyse the data according to the proposal and provide only research findings and outputs back to clients.  

All research proposals are subject to a robust internal Research Governance and Ethics review process before commencing. A list of all approved research proposals and the client organisations involved is available on our Public Register of Research (in development).  

Central to the operation of the Network is the Research Governance and Ethics Framework[1] . 

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The framework is comprised of six inter-related principles which ensure the Network: 

1. Supports Real World Evidence generation which has clear benefits for clients and serves the public good.
2. Protects patient confidentiality and operates in accordance with recognised standards of data security.
3. Uses methods of clinical data access, curation, analysis and delivery which are subject to sufficient human oversight to maintain data integrity and quality to recognised standards. 
4. Clinical data used and its processing of are consistent with applicable legal and regulatory requirements. 
5. Actively engages and involves patients and members of the public in its operation. 
6. The access, use and sharing of clinical data is as transparent as possible, and communicated clearly and accessibly to the public. 

Arcturis supports NHS organisations to ensure patients are informed about the Real World Data Network and the options available to stop their Confidential Patient Information being processed by NHS staff so anonymised clinical data can be made available to the Network if they wish.  

Patients in England are free to opt-out of their Confidential Patient Information being used for all research and planning purposes – including by Arcturis – by using the National Data Opt-Out.  

Information about the National Data Opt-Out is provided in the explainer video from NHS England[2] below, and at

https://www.nhs.uk/your-nhs-data-matters/.

Information about opting-out in Northern Ireland, Scotland and Wales is available from Understanding Patient Data at https://understandingpatientdata.org.uk/your-choices.    

Patients also have rights which they can exercise under UK data protection legislation. More information about these is detailed in our Transparency and Privacy Notice. 

Does Arcturis buy patient data? 

No. All anonymised clinical data made available to the Real World Data Network remains under the ownership of the data provider. 

Does Arcturis sell patient data? 

No. Arcturis sells its services and the Real World Evidence generated from anonymised clinical data, not the data itself. Clients are not permitted access to anonymised clinical data made available through the Real World Data Network.  

Does Arcturis hold patient data? 

Where it is not possible or practicable for Arcturis to analysis anonymised clinical data in ways that allow it to remain within the NHS, it is transferred to Arcturis. It is held within our high compliance research under strict technical, organisational, and contractual information security controls.  

How can I stop my data being processed for the Arcturis Real World Data Network? 

There are a variety of ways patients can stop their Confidential Patient Information being processed by NHS staff so anonymised clinical data can be made available to the Arcturis Real World Data Network. These vary depending on where you live, how broadly you would like your wishes to apply, and the opt-out options implemented by individual NHS organisations. 

An overview of the options is provided in the “Ensuring patients have control – Opting-out and more” section of this webpage.

A more comprehensive explanation of the choices available regarding how your data is used beyond individual care is available from Understanding Patient Data at:

https://understandingpatientdata.org.uk/your-choices. 

How does Arcturis make sure my patient data is anonymised before being used for research? 

Arcturis only requests access to the specific clinical data needed to generate Real World Evidence, not a patient’s entire electronic record. Staff at NHS organisations find and extract only the data requested and ensure anything not requested is removed. This will include types of data that identify you – such as your name, address, and NHS number.  

All clinical data shared with Arcturis is quarantined and checked for anything which could be identifying before being made available to researchers. Strict information security controls are applied during and thereafter this process to ensure the likelihood of a patient being re-identified from anonymised clinical data is kept negligible.    

How is the quality and accuracy of patient data ensured? 

Arcturis works closely with NHS organisations to maximise data quality and to ensure any deficiencies are understood and accounted for. No data of insufficient quality is used to generate our regulatory-grade Real World Evidence. 

During the curation and analysis of data, quality checks are completed, and corrective action taken if required. All Real World Evidence generated for clients is also thoroughly quality assured before being provided and any limitations of the evidence clearly explained.     

Further detailed and technical information on how and why different types of data are process as part of the Arcturis Real World Data Network is available in our

Transparency and Privacy Notice.  

If after reading this notice you have any questions or queries, or would like any further information, please do not hesitate to:

Contact us.  

[1] Adapted from data from the UK Statistics Authority licenced under the Open Government Licence v.3.0 

[2] Contains public sector information licensed under the Open Government Licence v3.0.  

[3] US Food and Drug Administration, et al. Real-World Evidence. 2022. https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence. Accessed 10 May 2024.