Information for Patients and the Public
This webpage was co-developed with patients and members of the public.
Our thanks to them for their time, generosity, and support.
Overview
This section provides more information about the important roles that patient data can play in improving health care, how Arcturis works with these sensitive data including the role of our Real-World Data Network, and how we work with NHS trusts and life science clients.
There is also further details about the Arcturis Research Governance and Ethics Framework which underpins our Real-World Data Network to ensure our research is conducted accurately, securely and for the public benefit.
Contents
The importance of patient data for improving health care
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.
The Arcturis Real World Data Network - How Arcturis uses anonymised clinical data for medical research
Arcturis develops partnerships with individual 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.
How Arcturis works with the NHS
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).
How Arcturis works with 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).
The Arcturis Research Governance and Ethics Framework – How Arcturis ensures research is conducted securely, accurately and for public benefit
Central to the operation of the Network is the Research Governance and Ethics Framework[1] .
The framework is comprised of six inter-related principles which ensure the Network:
- Supports Real-World Evidence generation which has clear benefits for clients and serves the public good.
- Protects patient confidentiality and operates in accordance with recognised standards of data security.
- 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.
- Clinical data used and its processing of are consistent with applicable legal and regulatory requirements.
- Actively engages and involves patients and members of the public in its operation.
- The access, use and sharing of clinical data is as transparent as possible, and communicated clearly and accessibly to the public.
Ensuring patients have control – Opting out and more
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
Choose if data from your health records is shared for research and planning – NHS
Information about opting-out in Northern Ireland, Scotland and Wales is available from Understanding Patient Data at
Choices in how your data is used beyond individual care | Understanding patient data
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.
Arcturis Real World Data Network: Transparency and Privacy Notice – Arcturis
Frequently Asked Questions
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 Section 6 of this webpage, “Ensuring patients have control – Opting-out and more”.
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.
Glossary of Terms
| Term | Meaning |
| Anonymisation | The process of rendering identifiable data anonymous. |
| CDM | Common Data Model; a standardized way of organizing and storing data. |
| Clients | Pharmaceutical, biotechnology, academic and NHS research organisation from the UK and around the world. |
| Clinical Data | Information about people’s health, care, or treatment, typically stored in hospital or GP records. |
| Confidential Patient Information | Information which identifies you and says something about your health, care, or treatment. |
| Federated Analysis | A method of extracting insights from data on different systems without requiring the data to be brought to a central location. |
| Five Safes | A set of principles for the use of data originated by the UK’s Office for National Statistics (ONS):
Safe People: Only trained and specifically authorised researchers can access the data Safe Projects: Data is only used for ethical, approved research that has the potential for clear public benefit Safe Settings: Access to data is only possible using secure technology systems Safe Data: Researchers only use data that have been de-identified to protect privacy Safe Outputs: All research outputs are checked to ensure they cannot be used to identify subjects |
| National Data Opt-Out | A service in England that enables the public to register to opt out of their Confidential Patient Information being used for purposes beyond their individual care and treatment. |
| Real-World Data | Data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.[3] |
| Real-World Evidence | Clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of Real World Data. [3] |
| Secure Data Environment(s) | Data storage and access systems which allows approved users to access and analyse data without the data leaving the environment. This is typically done by following the ‘Five Safes’ principles (see the ‘Five Safes’ entry in this glossary for further information). |
| Secure Database Server | A physical or virtual machine running a database that has been hardened to protect its confidentiality, integrity, and availability. |
| Standardisation | The process of making things of the same type all have the same basic features. |
Where to find more information
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:
References
[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.