Clinical trials- a ship changing course in the midst of a storm- decentralisation

Dr Lennard Lee- Opinion Editorial (UK COVID/cancer clinical lead).

The future direction of clinical trials has been re-defined by the pandemic like a ship changing its course in the midst of a storm.

The most notable features causing debate is the speed of coronavirus trials. This crisis has provided the burning platform for clinical trials to modernise, become more efficient, effective and significantly shortened the time for patient impact.

Trials that by right should take 5-10 years, routinely taking less than a year and are hyper-accelerated. Just to give you a few examples, the Oxford AZ vaccine studies recruited 32,000 people in 10 months. Many other successes have been delivered in similar time scales, the Recovery study, 47,000 people in 12 months, the Falcon MoonShot LFD study, 1,000 people in 36 days and the Panoramic study with 4,700 people in 3 months.

It is still argued that these trial timelines can only happen for COVID-19 studies. It is said that these lessons and innovations have little/no potential for other disease types, like cancer research studies.

However, in the last year, cancer studies are now also starting to accelerate. Our UK COVID Cancer study, recruited 4,300 patients in 5 months. And the NHS-Galleri study, testing a new cancer blood test recruited 140,000 in 10 months.

There appear to be many acceleration points that can be learnt from COVID-19 studies, but potential one that seems to be making the most impact is going for decentralised trials. These are known by different names such as virtual, home, remote, siteless trials. Whatever it is called, these trials have increased participation, reduced drop-out rate and helping to accelerate trials.

Decentralised trials focus on patient-centred trials, utilising technology and a hybrid approach to provide an alternative to pre-pandemic inflexible site-anchored systems. By reducing the need for patients to travel to specific sites, sites visits may be replaced by sites in the community, virtual assessments or even at-home elements. They are like a GPS navigation system, guiding patients to the finish line with less detours and delays.

The benefits of decentralised trials are like a treasure trove of gold, providing a wealth of benefits including.

  • Accelerating patient recruitment
  • Increasing participant diversity
  • Patients become more knowledgeable, informed and engaged
  • Gathering more diverse and applicable data sets
  • Improved reliability and accuracy of data
  • Easier reporting and analysis of results

I feel confident that 2023 is going to be an exciting year. The UK Covid Cancer program has led the way, like a trailblazer blazing a new path, in applying the lessons learned from the pandemic response to benefit cancer patients.

Our network of 86 centers have embraced decentralized trials and the research is hyper-accelerated, like a rocket reaching new heights. We are incredibly grateful for our 250 clinicians who have delivered the cancer pandemic response. Their ability to innovate at scale and deliver the fastest recruiting, and largest cancer studies of 2022 was so impressing.

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