Blog - BSMS

NHS DigiTrials: Existing data can support clinical trials and improve the health of patients in England

21 October 2024

Clinical trials are a form of research which examines how well new interventions work. Trials enable researchers to evaluate how well new treatments improve and extend the lives of patients. Often, to strengthen the findings from the trial, researchers want to access follow-up data on the long-term outcome of the patients in the trial. Historically this process has been expensive or lengthy. NHS DigiTrials offers a service that will make the data for trial follow-up available for linkage to clinical trial data, in one place, meaning better understanding of longer term outcomes of new treatments, improving healthcare across the country.

NHS DigiTrials is a relatively new service (started in 2019) powered by NHS Digital to support clinical trials, with the ultimate aim of improving NHS services and access to evidence based diagnostics, vaccines and treatments to improve the health of patients. It was developed and supported by a diverse panel, representing the voice of patients and the public. The panel offered valuable insights in designing an accessible service, and from the quote below it seems that continued collaboration with patients and the public will be central in shaping the future of the service.

“The Co-Development Panel played a crucial role in shaping our services to be inclusive and accessible. Their diverse perspectives, passion for representation, and honest feedback were instrumental in ensuring that clinical trials involve and benefit all communities. As we move forward, we remain committed to the principles they championed and will continue to prioritise patient and public involvement in our work.” Damian Bowler, Head of NHS DigiTrials

Patient data is already routinely collected from health and care organisations by NHS England and will be made available to approved researchers doing clinical trials through NHS DigiTrials (excluding patients who have actively opted-out of their health data being shared for planning and research purposes). NHS DigiTrials is offering a service to link trial patients’ NHS data to the existing trial data, so that longer term follow-up is possible. The data is under strict controls and will only be made available and shared with approved researchers, if it is relevant, lawful and used to benefit patient care, all of which will be assessed during the approval process. The data will be shared and stored safely and securely within a Secure Data Environment, adhering to robust governance, data protection requirements and information security. Details of the how patient data is stored and information about the National Data Opt-Out service can be found here.

NHS DigiTrials has supported multiple large-scale clinical trials through the services offered; feasibility, recruitment, communication and outcomes. Example projects NHS DigiTrials has been involved in can be seen below:

For further information about NHS DigiTrials, check out the webpage: NHS DigiTrials - NHS England Digital. If you have an enquiry or would like to know more, you can contact the team at enquiries@nhsdigital.nhs.uk

Transforming Health and Care - Introducing the NHS Federated Data Platform

13 November 2023

When we use NHS services our health data is collected and recorded. This data makes up our electronic health record, and includes things like demographics (such as age, gender, location), presenting symptoms, previous conditions, medication details, test results, notes, diagnostic codes, to name just a few! Due to the rich information it contains about our health, this data enables us to receive the care we need, when we need it, and has the potential to save lives.

The impact of patient data has the potential to go even further, to help more people, improve care and save more lives. This is only possible if health data is unlocked and shared between services, which as of yet hasn’t been achieved in the NHS.

At present, individual health data is securely stored in systems specific to the NHS service used by the patient. Whilst this is invaluable in supporting patient care given when patients use that specific service, this data is also vital in follow-on care for the individual using other NHS services, and also more widely in understanding patterns, identifying problems and addressing health inequalities.

Whilst this data holds so much potential for helping with healthcare improvement, it currently remains securely stored in the original service, separate from other NHS systems, not following the patient. This often results in frustration from service users and staff, and has the potential for things to be missed and care to be delayed, as patients fall through the gaps between services. The negative knock on effect this has for both the NHS in working efficiently and consistently at scale, and in regards to patient satisfaction and health outcomes is huge, and is something the NHS are aiming to address through the development and implementation of the NHS Federated Data Platform (NHS FDP).

What is the NHS FDP, and how will it work?

The NHS FDP will have the functionality to enable the many different data systems used within the NHS in England to connect, allowing patient data from the different services to be shared when needed. The NHS FDP will permit information to be shared within a secure and controlled platform, so services can work together to understand patterns, solve problems and plan for the future, whilst ensuring patients receive better, more consistent care.

Why does the NHS need a shared platform? What are the benefits?

As previously mentioned, the current way of working with patient data is challenging for the NHS and has many knock-on effects for staff, patients, and the wider population. A platform where data can be shared safely amongst services is exciting and has the potential to revolutionise and transform the health and care of NHS patients and the wider population for the better. Increased awareness and knowledge of population health patterns leads to better understanding of health problems. It highlights health inequalities which must be tackled, whilst also recognising and encouraging necessary service and resource improvements based on the future health and care needs of the population.

The promise of a connected and more efficient NHS service through the successful implementation of the NHS FDP, comes with the hope for a better service for patients, service users and staff. However, lots of questions remain: Can this new platform live up to its promise of a streamlined NHS service? Can the new platform learn from the mistakes and failing of previous NHS patient data sharing initiatives and have the public’s support? Can this new platform be the solution to improving clinical outcomes and addressing health inequalities?

How will my NHS patient data be handled?

As with previous NHS data-sharing initiatives, the public rightly continue to question how their data is handled, who has access and what are the risks? In regards to the development of the NHS FDP the NHS plans to collaborate with a commercial supplier to build the system and software. Whilst procuring data systems from commercial suppliers is routine work for the NHS, this procurement has been in the spotlight due to the contract size and interest in the existing relationship the NHS has with one of the potential suppliers – US tech firm Palantir.

Whoever is awarded this contract to develop the NHS FDP, the public will want to know and be confident that the relationship and power dynamics of the arrangement are fair and that the NHS remains in control. The public have expressed worry that the NHS could get locked-in to a relationship with a supplier, and want assurance that the NHS will be able to end the partnership whenever they wish. Other concerns raised include: What will the supplier be able to access and do with my NHS patient data? What safeguards and guardrails are in place? Is the supplier trustworthy? The NHS must address these concerns and engage with the public in a transparent and honest way. Failure to do so or staying silent will fuel distrust and worry, allowing alternative narratives to take hold.

Are public concerns being addressed?

The NHS are not naïve to the previous failings and concerns raised by the public, as well as the deep-rooted anger and upset caused as a result of a lack of public engagement and awareness in previous campaigns - in particular the opt-out response to the care.data initiative in 2014, and its successor, GPDPR, which was also badly received in 2021. It is fair to say that public (and professionals’) trust in these NHS data sharing initiatives has been badly damaged and will require a lot of investment and meaningful engagement to move things forward in an open and transparent way.

The NHS has recognised this and are taking positive, proactive steps toward building public trust and awareness in the development of the new NHS FDP. There is a strong commitment to ensure the NHS FDP is developed and implemented in a way that is transparent and accountable to the public in how their health data will be utilised and who will have access.

Here are just some of the ways the public has been involved and have engaged so far in the development of the new NHS FDP:

Public surveys and consultations: In 2022 the NHS published a consultation document on the FDP and received over 1000 responses from the public.
PPI groups: Have provided an opportunity to provide feedback on agenda and plans, to ensure the outcome of the FDP meets the needs of patients and the public - shaping development plans.
Public events: The NHS has hosted a number of public events to raise awareness of the FDP and gather feedback from the public. In 2023, a series of public events were held to discuss plans for the FDP, where questions and concerns from the public were addressed.

Other ongoing engagement activities with the public include; online surveys and social media engagement.

Addressing concerns and building trust will not be a quick fix, there will need to be detailed understanding of the public’s concerns, and meaningful engagement with the public so their voices are heard, to shape the project into something that is publicly accepted and most of all supported. In response the NHS has launched a £2 million public engagement campaign to actively involve patients in discussions about patient data and how their healthcare data will be utilised, and this will include continuous meaningful engagement work with the public in relation to the NHS FDP project.

What’s next?

The NHS FDP is expected to be operational in 2024 and recent pilots of the scheme have shown significant and measurable benefits.

One of the most important things the NHS must do moving forward is be transparent with the public and communicate openly the next steps, presenting the facts to the public clearly. Staying silent or keeping things quiet will only fuel worry and allow another narrative to fill the silence, breeding misinformation, suspicion and discontent, whilst exasperating the distrust left by previous NHS data-sharing initiatives.

Further information on the new NHS FDP can be found here via NHS England.

NB: Since writing this blog there have been new developments regarding the NHS data contract. In November 2023 NHS England awarded US tech firm – Palantir – a five-year contract worth £330m to set up and operate the NHS FDP. As expected, the response to Palantir winning this NHS data contract has been controversial, with concerns raised over the suitability of Palantir’s involvement. The British Medical Association has described this decision as ‘deeply worrying’. There will be some very difficult conversations to be had over the coming days and weeks.