With the details of almost every person in the UK, the health records held by the NHS are an invaluable resource for researchers. George Osborne reiterated the value of data in his autumn statement, highlighting it as a driver of growth through research and innovation and David Cameron spoke of it today. With this in mind the Department of Health is planning to create a new secure data service, called the Clinical Practice Research Datalink (CPRD), to open up data for medical research. This will bring together a usable database of records and support services, such as methodology planning and sample collection, into one comprehensive service, hosted by the Medicines and Healthcare products Regulatory Agency (MHRA). In a document published last month the Department outlined a timeline to create the new data service.
Currently, the General Practice Research Databank (GPRD) holds anonymised health information inputted by GPs and provides this data, and other tools, to support medical and public health research. It is currently run by MHRA and has been in use since 1987. However the database does not cover all NHS patients (over 630 GP practices are involved) and only includes primary healthcare data, although it does link to other external NHS records.
In 2008 the NIHR Research Capability Programme was created to deliver the Health Research Support Service (HRSS), which “helps researchers to access and analyse a wide range of health-care and other relevant information to support their research projects.” A handful of HRSS pilot projects were set up in 2009 to test the logistics of the idea, the first one has just reported back.
In their 2011 Plan for Growth the government singled out the life sciences industry as an economic driver. In particular, the necessity for a comprehensive national health information system was stated:
4) The Government will build a consensus on using e-health record data to create a unique position for the UK in health research.
2.198 The NHS could offer unique opportunities for this country’s international competitiveness in health research. Government can create the capacity to draw on the power of large linked data sets on a scale unprecedented here or elsewhere in the world. This would create unique opportunities for research in the UK, including more powerful uses of anonymised data sets and aggregated prescription data linked down to GP practice level. That can happen only if there is robust protection for individual patients' confidentiality and privacy. Enabling access through a managed health research data service would support clinical innovation and strengthen evidence of effectiveness, improving health outcomes. The Government will work with the National Information Governance Board and partners in the public and private sectors to publish plans by the autumn for a secure data service that is viable and affordable, and is focussed on linking the data sets which do most to strengthen the international competitiveness of our life sciences research.
So what’s the plan?
The new Clinical Practice Research Datalink (CPRD) will combine the GPRD and HRSS services into one comprehensive system. Building on the GP-only data of the GPRD the CPRD will link data from GP and hospital care.
The CPRD is to be established by 1 April 2012 and will provide capability, products and services over three areas: data services, providing data for health professionals and researchers; interventional research services, helping to plan projects, recruit participants and provide logistics during the project (e.g. biological sample collection and questionnaires); and research services, methodology guidance, feasibility studies and even the ability to conduct research on behalf of customers.
This will be delivered incrementally over 4 years from April 2012, with some of the services being available for researchers in 2012. It will be hosted in the MHRA on behalf of NIHR and MHRA. The report sets out the milestones to be achieved over this time. It is expected to cost £60 million.
The service will be available to professionals within the health service as well as pharmaceutical industry, academics and other professionals.
What does this mean for medical research?
AMRC has been working with its partners to encourage the government to streamline the regulatory process of the use of patient data, which in the past has seriously delayed clinical trials, and to find a way to open up the data held within the NHS without compromising patient confidentiality and confidence.
Patient data can be anonymised or identifiable, the latter meaning the researcher would be able to identify an individual through the data they are given. The CPRD will act as a “data safe haven” (as proposed in a joint Ministry of Justice and Wellcome Trust report in 2008) allowing researchers to be provided with an anonymised form of identifiable information, but whereby only the CPRD will actually have enough information to link to individuals.
Importantly, the CPRD will not have regulatory and approval functions, as with the GPRD, these will be dealt with externally. Research involving identifiable information is approved on a case by case basis by the Ethics and Confidentiality Committee (ECC) within the National Information Governance Board (NIGB), which Earl Howe has said will become part of the Health Research Authority (HRA) when this is created.
A national and comprehensive “cradle to grave” database of health information would be a fantastic resource for scientists, making Britain a more attractive and productive place to do research. And measures to increase public support and trust are welcome. But many questions remain, such as how researchers will access the database and, importantly, what and how much information will actually be available considering the government has cancelled the national IT system that would have centralised all NHS patient records? There will be opportunities for the research community to feed into ongoing discussions with the CPRD as they make their provisions and we’ll be keeping an eye out for any further developments that might answer these – and other – questions.
Major milestones to watch out for
December 2011 – Joint NIHR/MHRA announcement on implementation
March 2012 – CPRD in place (GPRD and HRSS merged, staff and governance framework ready to go)
March 2012 – 10 national datasets available for linkage
April 2012 onwards – engage GP practices in the project
April 2012 onwards – engage topic-specific research networks
May 2012 – enable data to flow and to facilitate clinical trials recruitment (stage 1)
June 2012–March 2013 – additional datasets added (type and number of datasets required will be decided in conjunction with the Expert Advisory Group for the CPRD)
June 2012 – CPRD linked to NIHR clinical trials gateway
Aug 2012 – engage devolved NHS of Scotland, Wales and N. Ireland for collaboration
Dec 2012 – enable data to flow and to facilitate clinical trials recruitment (stage 2)
April 2013 – User group meetings (UK and international)
April 2013 – Scotland, Wales and N. Ireland collaboration begins
June 2013 – social care datasets available
Dec 2013 – enable data to flow and to facilitate clinical trials recruitment (final stage)
June 2013–March 2014 – additional datasets added (type and number of datasets required will be decided in conjunction with the Expert Advisory Group for the CPRD)
April 2014 – user group meetings (UK and international)
June 2014–March 2015 – additional datasets added (type and number of datasets required will be decided in conjunction with the Expert Advisory Group for the CPRD)
Oct 2015 – joint NIHR and MHRA work to identify investment priorities