What does it mean for Policy Makers?
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What does this mean for policy makers?
The UK has proved its ability to deliver innovative and adaptive clinical research in the NHS, with remote methods of delivery adopted widely across different types of studies.
In the UK-wide vision for clinical research delivery, published in March 2021, government sets out the ambition to build on these learnings, by making the clinical research ecosystem more patient-centred, streamlined, efficient and innovative.
With increasing use of digital tools and remote methods of delivery across the globe, UK infrastructure and capability must keep pace to remain a globally attractive destination for the clinical trials of tomorrow and deliver truly patient-centred research for the benefits of patients and the public.
This is reinforced by the Lord O’Shaughnessy independent review on commercial clinical research in the UK, published in May 2023, which highlights the opportunity for the UK to “gain a global leadership position in the field of digital or decentralised approaches that enable people to take part in research through their GP or even at home.”
To explore how the UK can be a world-leader in these novel approaches, this project has consulted a range of stakeholders, including global industry, clinical trial design and delivery teams and patient and public contributors, and developed five proposed actions. These actions should be considered alongside government efforts to deliver recommendations from the O’Shaughnessy independent review and the commitments in the UK-wide vision for clinical research delivery.
How can the UK position itself as a world-leading destination for remote methods of trial delivery?
The following recommendations are aimed at governments across England and the Devolved Nations, regulators, funders and the NHS.
- Develop clear and consistent communication on the UK’s remote method of trial delivery offer, aimed at:
Sponsors and funders: to anchor more clinical trials using these approaches in the UK and promote adoption of these approaches
Clinical trial design and delivery teams: to raise awareness of existing capabilities and promote adoption of these approaches
Patients & the public: to raise awareness of the different ways in which participants can get involved in research and the benefits and drawbacks of these approaches
2. Reform regulatory guidance and processes to:
Enable and empower the research community to design studies with remote methods of delivery embedded
Support delivery of studies using these approaches in the UK
Provide appropriate flexible funding framework to support patient-centred trial delivery
Align clinical trial regulation with existing international frameworks
3. Enhance data and digital capabilities in the NHS by:
Implementing joined-up and accessible electronic health records
Increasing the collaboration and compatibility of existing digital networks within research
Developing a digitally-skilled workforce
Supporting technological and data processing development and innovation
4. Establish a routine mechanism for reviewing patient, public and participant preferences and experiences in relation to remote methods of trial delivery, to:
Inform the adaptation and implementation of approaches adopted by research design and delivery teams and research delivery networks
5. Measure and report on recruitment and retention for studies using remote methods of delivery routinely, to:
Evaluate effectiveness and ensure these approaches are being used appropriately to benefit patients and improve study delivery
How can the UK evaluate and articulate the impact of remote methods of delivery on trial performance?
Case studies of remote methods
Participant experience data
Evaluate experience of trial delivery teams
Performance metrics, including:
Trial delivery metrics (e.g., time to target)
Recruitment and retention, including relating to recruitment of diverse and under-served populations
Additional Reading
Decentralized trials getting some attention on the international regulatory front Published by Regulatory Focus (A RAPS Publication)
Mapping and analysis of the EU legislation on Remote Decentralised Clinical Trials including legal, regulatory, ethical and stakeholder recommendations for the conduct of the pan-EU pilot by Trials @ Home Consortium
The Topol Review - Preparing the healthcare workforce to deliver the digital future; Published by NHS Health Education England