A key component of the government’s growth plans for life sciences in the UK is now in place with the launch of the Clinical Practice Research Datalink (CPRD).
Hosted and managed by the Medicines and Healthcare Products Regulatory Agency (MHRA), the CPRD combines the resources of the General Practice Research Database (GPRD), which has been collecting (and making available to researchers) anonymised longitudinal medical records from primary care since 1987, and the Research Capability Programme piloted over the last four years by the National Institute for Health Research (NIHR).
As such, the CPRD is not so much about creating a new reservoir of data as establishing productive relationships between previously siloed datasets in primary, secondary and tertiary care, as well as streamlining the processes through which researchers can access those data.
Enriched information
The CPRD programme envisages the service being delivered incrementally over the next four years, in line with plans for the proposed NHS Information Centre for Health and Social Care to link datasets from GP and hospital care. This would give researchers access to enriched information on treatment outcomes and patient journeys through the wider care system.
These initiatives, as well as a forthcoming consultation on amending the NHS Constitution so that patient data would be “automatically included” in clinical research, subject to an opt-out provision, have raised concerns about data confidentiality/security and informed consent processes.
Announcing the CPRD launch, the MHRA was at pains to emphasise that it would be a secure research service, that patient data would be anonymised, and that no personal details would be shared with health researchers.
Informed consent
Some observers have suggested that the new services could run into problems with more stringent informed-consent procedures in a new European Union regulation on data protection currently in the pipeline.
Commenting last week during an online forum on commercial clinical research in the NHS hosted by The Guardian, Professor Dame Sally Davies, chief medical officer and chief scientific advisor to the Department of Health, said the CPRD would work with data controllers at general practices participating in the programme “to ensure that patients are aware that their anonymised data will be used and that they can opt out if they wish”.
As far as the European Commission’s proposed revisions to the EU’s Data Protection Directive are concerned, the UK “is currently reviewing the impact this will have on processing of data”, Dame Sally noted.
“For research, the measures in the proposal look proportionate,” she added. “Our concern is how this will be put into practice. We will work to get the best outcome for patients, GPs and the health service.”
At the forefront
The collaborative approach taken with the CPRD “will be at the forefront of delivering a world-class health research service by allowing life science researchers to draw on the power of large linked anonymised data sets on an unprecedented scale”, the MHRA stated.
“It will also provide novel and powerful ways in which clinical trials can be undertaken,” the agency observed. It cited the following ways in which the CPRD would build on current support for health researchers:
• Data Services: Access to data for researchers (NHS, social care and others); data matching and linkage services; data validation and access to real-time data to facilitate surveillance activities and support the public health agenda.
• Interventional research services: Feasibility of research proposals; site- and patient-level recruitment; full electronic-data (e-data) services; linkage services for clinical trials; biological sample collection and linkage; patient-reported outcomes collection and linkage.
• Research services: Advice on research methodology, governance and feasibility; consultancy services including the provision of patient and/or healthcare professional input; undertaking research studies on behalf of customers.
