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What is an adaptive clinical trial?

A clinical trial is a way of testing possible new treatment regimes which could prove more effective or cause fewer side effects than those being used.

Traditional clinical trials test only one drug or different aspect of a treatment at a time. As a result, it can take several years to produce results, wheter positive or negative. This is not helpful for patients with a high-grade, aggressive tumour.

In an adaptive clinical trial, researchers can add in new drugs or combinations of therapies as the trial goes along, in response to the improved or worsening condition of the patients involved. The effect is to speed up results, with the aim of making more effective and kinder treatments available more quickly.

Clinical trials and coronavirus

Those who are already part of a clinical trial will generally continue to be treated, but many clinical trials are now halting recruitment.

If you're already part of a trial

Although there may need to be some adjustments to protocols, those already on a trial will generally continue to be treated. Of course, safety is the top priority.

If, for any reason, a trial can’t continue or you aren't able to remain part of the trial, you will still be given standard care.

You should continue to talk to your doctors or trial team if you have any concerns. Some trial co-ordinators have suggested that email is better, as these are easier to monitor than phone calls when people are working across different sites and emails create a trail.

I want to take part in a clinical trial

Across the UK, recruitment onto trials is being managed on a site-by-site and case-by-case basis, but most trials are halting recruitment to:

  • redploy staff to deal with Covid-19 on the frontline
  • make research facilities available for tackling Covid-19
  • make sure there is sufficient staff to monitor patient safety for those already on trials
  • limit the contact between people, especially those who are particularly vulnerable.

The decision to halt recruitment is often being taken by the organisations who own the trial, not the unit/site itself.

It's important to remember that not all trials are halting recruitment and there may be very rare exceptions where a doctor can apply for you to join a trial. So, if you're interested in joining a trial you should still discuss it with your doctor to get the latest advice and information.

Why we need adaptive clinical trials

If you have been diagnosed with an aggressive brain tumour and given no hope of a cure, it is very difficult to understand why you shouldn't be allowed to try new treatments or combinations of treatments that might extend your life.

This lack of flexibility in clinical trials has been one factor in historically slow progress towards more effective treatments for high-grade brain tumours.

These tumours progress very quickly – there is simply not enough time for a patient to take part in different trials, each of which tests a single potential treatment.

Funding adaptive clinical trials

The adaptive clinical trials we are currently funding are:

The Tessa Jowell Adaptive Clinical Trial

We recently announced funding for a brand new adaptive clinical trial to improve treatments for those diagnosed with a glioma, the most common type of brain tumour. The flexible design of the trial will give more patients in the UK the opportunity to be part of a clinical trial and access the newest treatments – something that Baroness Tessa Jowell felt strongly about.

We're currently reviewing applications from researchers who have applied for this funding following input from our patient-led Research Involvement Network, and look forward to the launch of a new trial that will speed up the development of better glioma treatments.

BIOMEDE

BIOMEDE is the UK's first adaptive trial for children with a brain tumour

Led by Dr Darren Hargrave and funded by The Brain Tumour Charity, the international trial will test improved treatments for children diagnosed with DIPG – one of the most deadly and aggressive childhood brain cancers. As an adaptive trial, BIOMEDE is designed in a smart and flexible way that allows clinicians to eliminate failing drugs and introduce new drugs without restarting the trial. This means we can get new and better treatments to children who desperately need them, much more quickly, saving valuable time and cost.