Deliver complex and innovative trials in the UK

Proven track record  of delivering innovative trials

Clinical trials are evolving to find new, faster and more efficient ways to bring new treatments to patients. The UK began pioneering new approaches, such as the multi-arm multi-stage trial design, as far back as 2005 with the STAMPEDE trial. We continued to break new ground with trials like the world-leading RECOVERY and PANORAMIC platform trials during the COVID-19 pandemic.

Consequently, we have a proven track record in helping commercial and non-commercial researchers to plan, set up, and deliver a range of novel and innovative clinical trials.

Complex innovative design (CID) is a broad term used to describe evolutions in trial design and delivery that improve the speed and efficiency of clinical trials and ultimately shorten drug development timelines. Often the complexity or innovation is in the trial design (methodology), but it may also exist in the set-up, recruitment, delivery, or the statistical analysis and mathematics that underpin the trial (innovative delivery). 

Complex and innovative trial designs (methodologies)

Any trial design that differs from the standard randomised controlled trial (RCT) design and delivers results more efficiently, reduces the study timeline and maximises the knowledge gained could be described as novel or innovative. Common examples of methodologies that are considered complex and/or innovative include:

• Adaptive (umbrella, basket, platform, dose-ranging)
• Targeted or stratified
• Real-world
• Bayesian.

The UK health and research system fosters collaborative approaches and in some therapeutic areas platform trials have been established to help accelerate the development of treatments. Take the Octopus trial for example, a multi-arm, multi-stage trial for progressive MS (multiple sclerosis), which offers a smarter way of testing potential treatments for progressive MS.

Innovative clinical trial delivery

When we talk about “innovative delivery” we are focusing on the set-up and the delivery of the trial, as opposed to the design. The design may be simple or standard, but the way it is delivered may be innovative which results in it being more streamlined, efficient, quicker or more patient-friendly. For example, research that is delivered using:

• electronic patient records and data linkages
• research registries and bio-repositories
• digital tools for electronic patient reported outcomes (ePROMs)
• streamlining processes across sites
• risk adaptation (e.g. virtual monitoring, proportionate Source Data Verification (SDV))
• proportionate consent (e.g. cluster randomisation, emergency settings)
• virtual, hybrid, decentralised and/or siteless trials
• health services research and public health research.
   

Support to deliver your complex innovative trials

We can help you plan, place, and perform your complex or innovative trial. If you are interested in designing or delivering a complex trial, or exploring what opportunities already exist in the UK, contact our NIHR Industry team. We recommend you get in touch as early as possible to benefit from our full range of support and expertise.

We also help to ensure that the NHS workforce has the knowledge and skills required to deliver the next generation of clinical trials. We have developed an eLearning resource, which is accessible and free of charge to all NHS and NIHR staff (and other organisations on request) via NIHR Learn. If you are not affiliated with the NIHR or NHS and you would like to access this eLearning resource please contact our dedicated Industry team.

Innovative trials in action

You can explore our case studies and podcasts to learn more about the expertise, experience, capabilities, and support that exists in the UK relating to the design and delivery of complex and innovative trials.

These provide a sample of the expertise available.

Case studies 

Explore our collection of case studies to discover how we have supported the delivery of complex and innovative clinical trials.

Podcasts

Listen to our collection of podcasts which are designed to inform, educate and answer the common questions around the management and delivery of complex and innovative design trials.

Further information

This is just one of the ways we work in partnership with life science organisations to help you to plan and deliver research in the UK. Visit our NIHR support for the life sciences industry page to discover our full range of support. Or talk to our dedicated industry team to learn more about the support described here.

Contact the Industry team

If you're planning non-commercial research, take a look at our pages for Researchers.

Contact us

If you would like to learn more about the expertise and services described on this page, please talk to our dedicated Industry team.

Contact the Industry team