In recent years there has been a growing public awareness of data privacy and calls for greater transparency of data sharing, including assurances that healthcare data is safe, secure, and only used for its intended purposes. This has led to Trusted Research Environments (TREs) being considered the future method for access of healthcare data.
CPRD has provided access to anonymised patient data for research for the benefit of public health for 35 years. We have an excellent track record in ensuring that data is safe, secure, and only used for its intended purposes, as recently validated by an external NHS Audit. To further strengthen the secure, safe use of data for research, we have embarked on the development of a CPRD TRE.
About Trusted Research Environments
Trusted Research Environments (TREs), also known as Secure Data Environments (SDE) or Data Safe Havens, are highly secure computing environments that provide remote access to data for approved researchers to use for public health research.
TREs differ from widely used models of data access where researchers need to download data onto their computer to be able to use it for their analysis.
You can find out more about TREs in this document by HDR UK: https://www.hdruk.ac.uk/wp-content/uploads/2021/09/HDRUK_TRE-One-Pager.pdf
We are developing the CPRD TRE in line with the Five Safes framework, allowing approved researchers to access our data in a secure and controlled way.
The Five Safes are:
- Safe People – Researchers are trained and authorised to use the data safely
- Safe Projects – Research projects are approved by data owners for public good
- Safe Setting – A secure environment that prevents unauthorised use
- Safe Data – Data is treated to protect any confidentiality concerns
- Safe Outputs – Approved outputs that are non-identifiable
The Goldacre Review
In February 2021, Professor Ben Goldacre was commissioned by the UK Government to review safety and security in the use of health data for research and analysis.
The Goldacre Review – Better, broader, safer: using health data for research and analysis – was released in April 2022 and made 57 recommendations focusing on the use of TREs as the future direction of travel for a strengthened and consistent management and access of healthcare data.
In June 2022, the Department of Health and Social Care released the Data saves lives: reshaping health and social care with data policy paper, which supported the recommendations in the Goldacre Review.
In line with this UK-wide direction of travel, our major strategic aim is therefore to move to a predominantly TRE-based model for data access and analysis.
Most research that utilises our data will take place within the TRE but there may be limited instances, such as patient consented trials, where it will be possible for data to leave the TRE to be combined with other datasets for analysis.
What we have delivered
In April 2022 we began working on the first iteration of our TRE. This initial version allowed our researchers to log into a secure environment and use tools such as R, Python and Stata to analyse synthetic (artificial) data.
In April 2023, we tested a second iteration of the TRE with internal and external users. This version allowed researchers to log in to dedicated areas of the secure environment, called workspaces, and analyse anonymised real-world data.
Next steps
In November 2023 we plan on delivering the third iteration of the TRE, which will build on the features of previous versions, as well as providing a mechanism for requesting safe outputs.
In mid-2024, we plan on launching the first live version of the TRE.
We will continue to update this page as we progress through the development stages.
Further information
Medicines and Healthcare products Regulatory Agency Delivery Plan 2021-2023