Safeguarding Patient Data
Patients are at the heart of our work.
The research we undertake relies on access to patient data and we understand the responsibilities working with these sensitive data brings.
Working Responsibly With Patient Data
Arcturis is using health data to improve decision making across the discovery and development pathway to support the approval and adoption of innovative medicines and deliver better outcomes for patients.
We have developed frameworks and procedures to ensure this research is conducted to the highest standards of governance and scientific excellence. Any health data we curate and insights we generate are done ethically to facilitate valuable research and innovation to deliver benefits to patients whilst safeguarding the confidentiality and privacy of patients.
Introducing Our Real-World Data Network
To ensure the creation, curation, and use of our regulatory-grade datasets for observational research follow robust and standardised procedures, we operate a HRA-approved research database called the Arcturis Real-World Data Network.
The Real-World Data Network harmonises various models of data provider relationship and data access to generate regulatory-grade, Common Data Model-structured disease-specific collections of anonymised clinical data for use in observational research.
The anonymised clinical data provided encompasses the broad spectrum of structured and unstructured data required to generate regulatory-grade real-world evidence related to hospital-managed treatment pathways.
These are curated by disease and include a range of information including demography, diagnostic codes, procedure codes, medications and prescribing details, referrals, imaging reports, raw images, genetic data, and laboratory tests.
Data is provisioned and curated using our common data model into a unified, structured research database using a ‘least access’ methodology. This methodology minimises flows of anonymised clinical data out of provider organisations, helping to maintain confidentiality, data quality and integrity.
The Real World Data Network has received research database ethical approval from the NHS Health Research Authority Yorkshire & The Humber – Leeds East Research Ethics Committee (REC Reference: 24/YH/0164).
In line with our conditions of support, all internal and commissioned research projects with clients conducted under the Network’s procedures are regarded by the NHS HRA has having Research Ethics Committee approval.
Our Research Governance and Ethics Framework
Foundational to the Network is our Research Governance and Ethics Framework, which dictates and supports the objectives of the network, ensuring that any human health data we curate is done ethically and securely.
Adapted from the ethical principles used by the UK National Statistician’s Data Ethics Advisory Committee*, our framework underpins and informs all aspects of our research operations.
The framework comprises of six multi-faceted and inter-connected domains.
*Adapted from data from the UK Statistics Authority licensed under the Open Government Licence v.3.0.
Learn more about the six domains:
Public Good
What we say…
The use of data has clear benefits for users and serves the public good.
What we do…
Through our Real-World Data Network, we ensure all research projects we undertake have a clear benefit for clients and patients or the wider public. In line the guidance from the UK National Data Guardian, we ensure that for each project:
- The public at large or a subset of the population would benefit from the research.
- The nature of that benefit is clear and is likely to materialise.
- Risks to the public arising from the research are identified and appropriately avoided or managed.
Legal & Regulatory Compliance
What we say…
Data used and methods employed are consistent with legal and regulatory requirements such as Data Protection Legislation and the common law duty of confidence.
What we do…
Arcturis has received ethical and legal approval from the NHS Health Research Authority for the Real World Data Network research database:
- Research Ethics Committee Favourable Opinion (REC ref: 24/YH/0164)
Legal support for the common law duty of confidentiality to be temporarily lifted under Regulation 5 of the Health Service (Control of Patient Information) Regulations 2002. This support allows NHS trust staff who do not provide direct care to process confidential patient information without consent so only anonymised clinical data can be made accessible to Arcturis. Support has been given following advice from the Confidentiality Advisory Group (CAG ref: 24/CAG/0096)
Confidentiality & Data Security
What we say…
A data subject’s identity (whether person or organisation) is protected, information is kept confidential and secure, and the issue of consent is considered appropriately.
What we do…
Unless a patient has given consent, no identifiable clinical data is shared with Arcturis. All clinical data accessed through the Real-World Data Network is anonymised.
Through our unique ‘least access’ methodology, we work in ways which allow patient data to remain within NHS provider organisations wherever possible without impacting research integrity or feasibility. Where anonymised clinical data is shared with Arcturis, it is protected to the highest domestic and international standards of data security:
- ‘Standards Exceeding’ against the NHS Data Security and Protection Toolkit.
- ISO27001 Information Security Management System certification.
- NCSC Cyber Essential Plus certification.
Patient & Public Engagement
What we say…
The views of the public are considered in light of the data used and the perceived benefits of the research.
What we do…
Arcturis is supported by our Patient and Public Advisory Panel. Demographically and geographically diverse, with rich-lived experiences of hospital-managed treatment pathways, the Panel is meaningfully and tangibly involved in our projects and research operations.
Through the Panel, and wider engagement with patient representative groups and the public, we ensure we consider and integrate their views and opinions into our ways of working in alignment with the Four Principles for meaningful involvement of patients and the public in health and social care research.
Quality Management
What we say…
The risks and limits of new technologies are considered and there is sufficient human oversight so that methods employed are consistent with recognised standards of integrity and quality.
What we do…
We have collated guidance from across industry regulators (e.g. FDA, EMA, MHRA), technology appraisers such as NICE and academic research to produce a comprehensive Data Quality Framework. This allows us to report and monitor metrics relating to how plausible and complete data is and whether in conforms to pre-specified data standards.
Transparency
What we say…
The access, use and sharing of data is transparent, and is communicated clearly and accessibly to the public.
What we do…
All research projects approved to be conducted through our Real-World Data Network are listed on our Public Register of Research (in development).
Through a process of co-production and continual improvement with our Patient and Public Advisory Panel, information for patients and the public is developed to be as accessible and understandable as possible.
Beyond being principles against which we aspire to, each domain is operationalised using a risk-based and context-specific management system of continuous improvement. We consider the needs and expectations of data providers, clients, regulators, policy makers and patients and the public, and implement robust yet proportionate procedures to ensure these are met. Through an ongoing programme of internal and external audit, assurance and horizon scanning activities, we monitor and refine our operations to ensure alignment with good practice and trustworthiness.
How organisations work with Arcturis
Through our data partnerships in the UK, Arcturis can provide real-world health data insights to pharmaceutical and biotechnology companies that can be used across the discovery and development pathway including to optimise clinical trials, expedite regulatory submissions and support long-term safety and efficacy outcomes.
We have also created our very own Patient and Public Advisory Panel to support these efforts and ensure we are consistently invested in generating work for public good.
More Information
More information about the Arcturis Real-World Data Network is available on our patient and public co-produced explainer webpage:
Information for Patients and the Public
Detailed and technical information about how and why different types of data are processed in relation to the Network is also provided in the Transparency and Privacy Notice webpage:
Transparency and Privacy Notice
All research projects approved to be conducted through our Real-World Data Network are listed on our Public Register of Research (in development).