To ask the Secretary of State for Health
(1) what steps he plans to take to increase the availability of clinical data for research.
(2) what discussions he has had with the European Medicines Agency and the Medicines and Healthcare Products Regulatory Agency on whether clinical data should be published for the purposes of research.
The Government launched the Clinical Practice Research Datalink (CPRD) in March 2012. As agreed in the “Strategy for UK Life Sciences”, the CPRD is the result of a £60 million investment by the National Institute for Health Research and the Medicines and Healthcare products Regulatory Agency (MHRA) and will provide access to data that support clinical trials and population observational studies on an unprecedented scale.
The CPRD operates across England, connecting patient information from general practitioners and hospitals to other records, such as disease registries, and holds the resultant information in anonymised form to protect patients’ privacy. The combined datasets can be used to answer medical research questions, and the results shared via peer reviewed publications. Future projects include the addition of air pollution data, social care records and potential for working with UK Biobank. The CPRD also aims to link with similar systems that cover populations in Scotland and Wales. Governance approval is sought for all new data linkages.
Since the service was launched in March 2012, 16 global pharmaceutical companies have been granted CPRD data licences, over 100 research studies have been submitted and 623 researchers have registered on the CPRD website. We will build on this early platform to provide an invaluable resource for the research community.
Clinical data and linked data, in a research-usable, anonymised format, are made available via the CPRD to a wide range of researchers for use in approved research projects. These research projects meet the needs of medicine/device regulators as well the needs of commercial companies required under regulations to undertake specific research studies. Discussions between CPRD and researchers, regulators and commercial companies are conducted on a regular basis to ensure the role that United Kingdom data can play in medicine/device safety and improvement in public health is maximised. The anonymised data are published against a specific independently approved protocol written by researchers who are under legal contract to CPRD for access to the required dataset for each research study protocol.
The CPRD is also developing specific data/research tools to help the understanding of the use of medicines in pregnancy and in children, as well as in the immediate period after launch of a new medicine. These tools are in response to the requirements of regulators such as the European Medicines Agency and the MHRA.
To complement the work of the CPRD, the Health and Social Care Information Centre (HSCIC) launched its new data linkage service on
Sir David Nicholson will lead on delivering the national health service vision for genomics, starting with a process to ensure that from April 2014 contracts are in place for whole genome sequences for NHS patients. Access arrangements will be considered as part of this process. To ensure public confidence in matters of confidentiality and access, this work will be monitored by the chief medical officer for England. Access would only be to anonymised and aggregated data to carry out research likely to benefit the health of UK citizens. The NHS will act as custodians of these data, ensuring that doctors have the information they need and researchers can carry out health research while privacy of the patients is ensured.