Patient data are extremely valuable for biomedical research. However, when it comes to sharing and using medical records for research, there is always a lot of discussion. Certainly huge benefits come from research using patient data, but privacy and confidentiality are concerns that should be taken seriously.
By accessing patient data, researchers can gain insights on efficacy of cancer treatments, can analyse genetic information to identify drug targets, and can better inform the management of patients and improve lifestyle and survival. At Cancer Research UK we believe that patient data should be used for medical research, so long as the appropriate safeguards are in place to protect privacy and confidentiality.
We caught up with Professor Willie Hamilton and Dr Fiona Walter, recently funded through our Catalyst Award, who told us about their experience with data and why access to patient records is important for their research.
With their innovative CanTest project, Fiona and Willie aim to improve and develop new ways of diagnosing cancer in GP surgeries. They plan to identify existing and emerging diagnostic tests, evaluate the availability, acceptability, accuracy, and cost-effectiveness of cancer tests and explore the future potential of innovative diagnostic biomarkers.
Of course, essential to this work will be the collection, storage and availability of patient data. Access to medical records and collaborative data sharing will be crucial for them improve cancer diagnostics and primary care.
What type of data do you need to conduct your research?
“For CanTest, the data will largely be on the symptoms that the patient has experienced, to see why a cancer test may be sensible. This will be supplemented by other important patient factors – age, sex, family and personal history of disease, and genetic predisposition. Then we need to know – in considerable detail – the test that has been offered/performed, and its result. Finally, of course, we will need to know if the patient transpires to have cancer, plus ideally details about the cancer, such as staging. That examines the test performance.
“There is another key aspect which is test acceptability and safety. It’s all very well knowing a test ‘works’. It’s just as important to know: is it acceptable to patients and clinicians? Is it safe? Are the results acted upon? Is it sensible from a health-economic viewpoint? Are there simply too many false-positives? The answers to these questions require a range of data: from qualitative work, to detailed health-economic modelling, to questionnaires/surveys.”
There is no doubt that to conduct this type of research at the highest standards, relevant data and information collected have to be accurately recorded and made accessible for analysis.
In the UK, you can apply to access patient data from different healthcare providers including cancer registries (Public Health England), NHS services (NHS Digital) and the Clinical Practice Research Datalink (CPRD).
These services are a critical part of the progress made against cancer, however some barriers to data access and sharing still exist.
What are the major barriers to patient data access and sharing?
“There seem to be two. The first is simple: that some existing databases – such as the Clinical Practice Research Datalink (CPRD) – won’t allow their databases to be shared. That’s not them being mean – they’re a great helpful resource, but they do need to recoup enough user fees to keep going, and they fear that too liberal data sharing will allow researchers to do studies on the shared database that haven’t been approved.”
When it comes to sharing patient data, there are many legal and ethical issues to consider. There are very strict controls about the sharing of any of the data. No personally-identifiable information can be shared unless patients have explicitly consented to share it or specific permissions are given from a valid research ethics committee. Safeguards are in place to prevent re-identification of individuals, and penalty measures can be used in case of data misuse. Strong safeguards are essential for ensuring patients and the public trust how their data is used.
Patient recruitment and full participation in research studies also a barrier
“There is a proportion of patients who are uncomfortable about their personal data being used for research and have not wished us to access their medical records, meaning – at times – it has been difficult to get the maximum value out of their participation. They may still be happy to participate in studies, but will either withhold their consent to their medical records, or will bar the data being shared more widely. This is a completely legitimate stance; entry into research studies must be wholly voluntary.
“Some patients are uncomfortable with their records being released, because they feel that their records are personal, rather than a resource for researchers. Having conversations about how patient data is used, and why, can change these perceptions – but it takes time…”
Certainly, it is crucial that that there is honest and open communication with the public about how their health data can be used for research.
Public surveys have shown that the vast majority of the public would be willing for their data to be used for research purposes, but they need to be informed on what the benefits are and what safeguards are in place.
Why is data sharing important?
A lot of progress in research is due to data sharing. In a previous story, we highlighted how the landscape is changing, with emerging technologies creating new opportunities and new ways to store large scale data or link patient data from different sources. Researchers, healthcare providers, funders and patients are increasingly placing more and more importance on data sharing and are already working to improve the way data are used for research.
“Data sharing is important because we owe it to the patients: patients have freely given their time and data. We must squeeze the data lemon till every drop of juice comes out.
“It is fair to say that without research using data we would still be ignorant about the true symptoms of cancer, and their true importance. We would still be in the NICE 2005 era, rather than the NICE 2015 era –and we may not have seen the cancer survival improvements in the last decade. Of course, not all the improvements can be attributed to better diagnosis, but some can! So big data has saved lives – for sure!”
At CRUK we are committed to ensuring that the data generated through our funding should be put to maximum use by the cancer research community and, whenever possible, is translated to deliver patient benefit. So our policy is that all data generated as a result of our funding, is shared widely and as freely accessible as possible whilst safeguarding intellectual property and the privacy of patients. If you’re applying for funding, be sure to familiarise yourself with our Data Sharing and Preservation Policy.