Project identifier: SDE_TVS_Proj_30
Project title: The Arcturis Real-World Data Network Research Database
Lay summary:
Arcturis runs the Arcturis Real World Data Network (“RWD Network”). This is a research database that helps NHS trusts store and share health data safely. Arcturis can use this data following strict rules.
Oxford University Hospitals (OUH) plans to share anonymised health data through the Thames Valley Secure Data Environment (TVS SDE). OUH will do this under formal agreements with Arcturis. OUH still owns its data.
This application asks for approval to keep OUH’s datasets in the TVS SDE. These datasets use information already collected in hospitals, like how severe a patient’s illness is and other clinical details. The goal is to help patients get new and better treatments faster, improve health outcomes, and reduce the impact of oncology diseases on the NHS.
Arcturis is setting a new standard for collecting and using real-world data (RWD). This data will help regulators, policymakers, NHS partners, doctors, scientists, and industry. By creating detailed patient groups and combining different types of data, Arcturis aims to improve drug discovery and development.
To make sure everything is done properly, Arcturis uses strict and standardised processes. The RWD Network works with NHS trusts to share anonymised data safely, either through Secure Data Environments (SDEs) or other secure methods.
Using the Arcturis Common Data Model (CDM), data from different sources is organised into a research database. This database contains anonymised data for many research projects. Wherever possible, the data stays within the NHS and is accessed securely rather than being moved. This approach keeps data safe and high quality.
NHS trusts can join the network as Data Providers. They share anonymised data under formal agreements. This data includes things like patient details, diagnoses, treatments, scans, genetic information, and lab tests. All data is anonymised before Arcturis researchers can use it.
Researchers trained in good research practices analyse the data for approved projects. Every project goes through ethics and governance checks first. Results are shared with Arcturis’ clients (pharmaceutical and bio tech companies) in reports, published in journals, and presented at scientific conferences.
The Arcturis RWD Network is different from other databases because it combines many types of hospital data into high-quality datasets for research. This makes the data reliable for regulatory use.
In phase 1, OUH is working on a cancer dataset for the network. Cancer is a major health problem in the UK, with over 385,000 new cases and 167,000 deaths each year. The NHS spends more than £5 billion annually on cancer care.
Survival rates have improved thanks to new treatments, especially precision medicine. Precision medicine aims to match treatments to patients who will benefit most and avoid harm. To do this, researchers look at things like age, genetics, clinical features, and other health conditions.
Randomised controlled trials (RCTs) are still the best way to test new drugs. But real-world evidence (RWE) is becoming more important. It helps show how treatments work in everyday life and can support drug approvals, especially for cancer. RWE can also help when trials are too small or don’t have control groups by creating “synthetic” control groups from real-world data.
This project aims to collect and improve cancer data from NHS records to create strong evidence for new treatments. This will help patients get access to better medicines sooner.
How will this help patients? Many cancer patients still need better treatments. Real-world data can help find new patient groups and tailor treatments to them. It can also help when trials are hard to run by providing comparison data, so new drugs can be approved faster.
Public benefit statement: Randomised controlled trials (RCT) remain the gold-standard for generating evidence in the drug approval process. However, real-world evidence (RWE) is increasingly being seen as an important tool for supplementing the clinical development, approval, and regulatory reimbursement of new therapeutics, particularly in oncology. Access to complete, high-quality real-world data (RWD) can provide much needed evidence on the patient characteristics and treatment pathways undertaken during the course of the disease in the UK to understand the patient and healthcare burden of specific diseases, it can provide much needed contextual information from a UK perspective where representation of UK patient populations are lacking in the RCT, and increasingly, RWE is being used to supplement early-stage, single-arm studies with RWD external comparators to enable the assessment of treatment response and safety over the current standard of treatment to better inform regulatory and reimbursement decision making for earlier adoption of new effective therapies. However, the utility of RWE fundamentally depends on the robustness and the quality of the RWD which underpins it. This partnership with OUH and TVS SDE therefore seeks to curate and enhance the availability of robust RWD derived from routine clinical electronic health records in key diseases areas, such as oncology, to enable the generation of high-quality RWE to support drug development and approvals, and ultimately improve the access to novel, effective precision-based medicines for cancer patients in the NHS
Organisation: Arcturis Data (UK) Limited
Date of signed agreement: 23.01.2024
Health Research Classification System (HRCS) category: Cancer and Neoplasms
Current project status: Live – data in use
Multiple-SDE project: No
Lead SDE: TVS SDE
Participating SDEs/organisations: TVS SDE
Further reading: Published research outputs are sign-posted on the Arcturis Public Register of Research