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New vision for harnessing the full potential of data-enabled trials published

NIHR-funded researchers have launched a blueprint highlighting innovative ways and best practice for using fully consented patient data in clinical trials for public benefit.

The COVID-19 pandemic has raised the profile of clinical trials and emphasised the need to deliver better, faster, more efficient trials for patient benefit. But considerable overlap exists between data required for trials and data already collected routinely in electronic healthcare records (EHRs) at hospitals and GP surgeries and collated in national datasets like those held by NHS Digital.

Now, a paper published in the BMJ highlights ideas and best practice to harness the full potential of data-enabled trials using EHRs and urges for a wider adoption of these methods for trials.

The publication follows NIHR co-funding a workshop in partnership with Health Data Research (HDR) UK and the Clinical Practice Research Datalink (CPRD), exploring the benefits of ‘data-enabled clinical trials’ by showcasing successful examples and imagining future possibilities.

The use of these healthcare system data for clinical trials is usually based on explicit consent from trial participants. This is separate from the NHS Digital national data opt-out service that allows patients to opt out of their confidential patient information being used for research and planning and has been extended until 30 September 2021.

Professor Matt Sydes, from the MRC Clinical Trials Unit at University College London, and the paper’s lead author, said: “Routinely-collected EHR offer great potential for faster, more efficient and less expensive trials reaching a broader catchment of the UK population.

“Opportunities exist to use these in innovative ways to decrease duplication of effort and speed trial recruitment, conduct and follow-up. Chances to learn and harness the power of information and technology to improve healthcare outcomes for everyone has never been better.”

Notable studies that have successfully used EHR throughout the research cycle, ranging from study design and feasibility to dissemination - including recruitment, conduct, data collection and analysis and interpretation.

Further examples of best practice will soon emerge from studies commissioned by NIHR as part of a cross-programme call for Data-enabled trials.

The researchers have made several recommendations in the report including:

  • Wider adoption of data-enabled methods for clinical trials
  • Early engagement of regulators with regards to monitoring and data verification
  • Patient and public involvement to robustly inform data-enabled trials
  • Increased interoperability of EHR systems

Researchers say that while some outcome measures are already reliably collected, others, like safety, need detailed work to meet regulatory reporting requirements.

NIHR's Health Technology Assessment (HTA) Programme provided funding for the co-funded workshop.

NIHR is also promoting the benefits of a data-enabled clinical research environment through the UK-wide Clinical Research Recovery Resilience and Growth (RRG) programme, which brings together partners from across academia, government, the NHS, regulators, medical research charities, industry, patients and the public. This plan is the first step towards the bold and ambitious vision to create a patient-centred, pro-innovation and data-enabled clinical research environment, which empowers everyone across the health service to participate in delivering research.