Electronic patient records and longitudinal cohort databases - which follow large groups of people over long periods of time, often decades - provide a rich data source with the potential to answer key questions in biomedical, clinical and public health research. The increase in the use of new electronic technologies, for example the NHS National Programme for Information Technology, is providing new opportunities for research in this area.
To take advantage of these opportunities, the Wellcome Trust, the United Kingdom's largest medical research charity, has launched a new initiative together with the Engineering and Physical Sciences Research Council (EPSRC), the Economic and Social Research Council (ESRC) and the Medical Research Council (MRC).
"Personal data from large groups of individuals, followed over their lifetimes, is a valuable tool for identifying and tracking health and disease in populations", stated Dr. Mark Walport, Director of the Wellcome Trust. "Many of the greatest advances in medical practice have come from improved public health measures. We must take advantage of developments in technology and data management to conduct research that will lead to health benefit. But personal data is, by its very nature, both sensitive and private. We must be transparent about the use of personal data and develop trust that data will be handled confidentially, securely and safely. This requires debate, dialogue and a sound regulatory environment with proper transparency and accountability."
Research using the health or medical records of large numbers of people has already provided valuable information that has helped save lives. In the 1950s, Professor Sir Richard Doll established the link between smoking and lung cancer by surveying the smoking habits of 40.000 British doctors. More recently, the Medical Research Council and British Heart Foundation Heart Protection Study of 20.000 patients showed that cholesterol can be reduced by taking statins. UK Biobank, a major UK medical research initiative, is currently recruiting 500.000 people aged 40-69 from across the country with the aim of improving the prevention, diagnosis and treatment of a wide range of serious and life-threatening illnesses.
Chair of the Research Councils UK Executive Group, Professor Ian Diamond, commented: "With vast volumes of information being collected about each of us over our lifetimes, this research has the potential to have a huge impact on the lives of millions of people living within the United Kingdom. The research is vital to building further understanding on how, by involving and building confidence amongst the general public, this huge array of personal data can be used to benefit society."
Two recent reports on public attitudes to the use of personal data in research, commissioned by the Wellcome Trust - Armstrong V. et al, "Public perspectives on the governance of biomedical research: a qualitative study in a deliberative context", carried out by the University of Surrey - and commissioned by the Medical Research Council - Ipsos MORI, "The use of personal health information in medical research: general public consultation" - indicated that people are willing to provide their personal data for research if they know why it is needed and have confidence in the integrity and confidentiality of the research process. However, the reports also uncovered "scepticism about guarantees of anonymity, based on people's experiences in their everyday lives of anonymity and confidentiality being breached through error, deliberate intrusion or lack of care".
"Establishing public confidence in this type of research is very important", stated Dr. Walport. "That is why we are encouraging research projects with an element of public engagement to allow the issues around the use of patient databases for research to be explored, and to raise awareness of the importance of such research for patient benefit and of the strict ethical and confidentiality processes in place."
The initiative is looking at three areas in particular:
- Health research using electronic patient records and major longitudinal cohort databases, particularly in the areas of population health and disease burden, major determinants of health (biological, social, economic or cultural) and health impact and effectiveness of health interventions and policies, including clinical trials implemented through national health systems.
- Training programmes and workshops for researchers in the use of complex patient record and cohort databases.
- Professional and public engagement activities to explore issues around the use of patient databases for research, and raise awareness of the importance of such research for patient benefit.