Deliver decentralised clinical trials in the UK

On this page, you will find information about how the NIHR can support you to deliver your decentralised clinical trial in the UK.

Unique capabilities to support the delivery of decentralised clinical trials

Clinical trial delivery in the UK is evolving. Research participants expect more choice in how they participate and, where appropriate, this means taking trial activities to the patients rather than using the traditional paradigm of bringing patients to a trial site. These new ways of delivering research are referred to in different ways, such as remote, decentralised, virtual or hybrid trials.

In the UK, the more commonly used term is ‘Decentralised Clinical Trials’ (DCTs) and the UK has developed unique capabilities to support the delivery of DCTs. The key difference to traditional trials is that decentralised models of clinical trial delivery enable participants to choose how and where they take part in some, or all, of the activities associated with a study. For example, monitoring activities may be completed remotely via home visits or through the use of technology such as apps, electronic monitoring devices, telemedicine and video consultations.

Decentralised trial delivery holds many benefits for funders and sponsors of research. For example:

• Improved patient recruitment: DCTs allow participants to engage in trials from the comfort of their homes, reducing the need for travel to clinical sites. This can enhance recruitment by overcoming geographical constraints and broadening the pool of potential participants.
• Increased patient retention: Reducing the need for frequent site visits reduces the burden on participants and makes participation more convenient. Study activities can be more frequent because they are not restricted by scheduled hospital visits and can therefore create a much richer and informed picture.
• Diverse participant demographics: By reaching a wider geographic area and making participation easier, DCTs have the potential to include participants from diverse backgrounds, leading to more representative study participation that overcomes population bias.
• Efficiency and cost savings: Fully decentralised trials, or virtual trials, often have faster recruitment rates as they are not restricted by geography and can access a larger and more diverse participant pool. This, combined with the decrease in the need for physical infrastructure such as clinical trial sites, may result in cost savings for commercial sponsors.
• Data quality and accuracy: Real-time remote monitoring and data collection tools allow for continuous oversight of data quality, enabling early detection of issues and prompt intervention.

Toolkit: Remote methods of trial delivery

The COVID-19 pandemic resulted in a significant shift towards trial delivery without in person, face-to-face contact - or “Remote Trial Delivery” as it became known across the research community. In 2020, we assembled a Remote Trial Delivery Working Group to consider challenges and enablers to this major change in clinical trial delivery. A report from the NIHR UK working group on remote trial delivery for the COVID-19 pandemic and beyond was published in December 2021. The group also created an open access toolkit of resources and guidance for researchers to support the transition to remote delivery.

Expanding UK capabilities in decentralised trial delivery

The UK has a growing track record of delivering decentralised trials. The routine use of e-consent and remote monitoring across a wide section of NHS trusts, means that the NHS is ideally placed to support decentralised clinical trials.

In addition, as the clinical trials landscape evolves, our NIHR-funded research delivery workforce is also evolving. Our Local Clinical Research Networks are transforming the way they support research delivery by developing new, flexible ways of working and adaptable models for deploying research delivery support.

Our Direct Delivery Teams are not tied to a specific site or therapeutic area. Instead, the research workforce responds to local research delivery needs as they emerge. These adaptable teams comprise highly skilled and experienced, forward-thinking professionals who are committed to innovating and path-finding non-traditional approaches to research delivery that can span organisations, care settings, medical specialties and even geographies.

These specialist teams can be engaged to support remote aspects of decentralised and hybrid trials which take place beyond the hospital clinic. They can help bring your research to the people.