It’s a testament to the progress that’s been made in medical research that we’ve been able to make our biggest ever investment in clinical trials in the last year. It’s just over 10 years since we set up our Clinical Trials Committee and since then we’ve gone from strength to strength.
Clinical Trials are important
The National Institute of Health Research (NIHR) describe clinical trials as the best way to compare different approaches to diagnosing, preventing and treating illness and health problems. Health professionals and patients need the evidence from trials to know which treatments work best. Without trials, there’s a risk that people could be given treatments which have no advantage, waste resources and could be harmful. Many treatments that are now commonly used were tested in clinical trials.
They also note that clinical trials aren’t always about testing medicines, they can be used to test ways to help people change their behaviour or lifestyle. This could for example include an educational programme designed to improve a person’s understanding of their medical condition so they can manage it more effectively.
Thanks to the evidence we have from our Patient Need research, we now understand the 24 key issues affecting blood cancer patients. As we delve deeper into these issues it might be that there are new opportunities for trials in partnership with other organisations.
At the moment most of our trials are about developing better ways of diagnosing different blood cancers; developing treatments that prevent and relieve the symptoms of blood cancer; managing side effects associated with different treatments; testing whether new drugs are safe; and establishing the safest dosage for each patient.
There are three main types of clinical trial:
Phase 1: these test the safety of new drugs or treatments and work out safe dosage levels for each patient.
Phase 2: these confirm the optimum dosage of new drugs and identify any side effects.
Phase 3: these compare new drugs or treatments with the best currently available treatments.
Our investment is mainly in early phase clinical trials, they give promising ideas the best chance of being made into effective new treatments.
First in human trials
This year we invested in our first ‘first in human’ trials (sometimes called a Phase 0 trial): with this kind of trial we’re aiming to find out if a drug behaves in the way researchers expect it to, following their laboratory studies.
From these trials, which take place with very small numbers of patients, we can find out if the drug reaches the cancer target; if it behaves as expected in the body; and how the cancer cells respond to the drug.
Our Trials Acceleration Programme
Three years ago we found that just 6% of blood cancer patients had access to early phase trials compared with an average of 19% of patients across all cancers. With the support and expertise of many people, led by Professors Charlie Craddock and Peter Hillmen we designed a solution: the Trials Acceleration Programme (TAP). This innovative project makes the most of partnership between the charity, the pharmaceutical industry and academia.
TAP uses a ‘hub and spoke’ model: coordinating a network of 13 trial centres around the UK that recruit patients simultaneously, while a central hub in Birmingham handles the paperwork. The unique design of the programme frees up researchers to do what they do best: ask questions that might lead to new treatments for patients, while the Birmingham hub deals with the complex administration of setting up trials, thanks to scientists with necessary skills in contract negotiation and ethics.
This means patients throughout the UK have access to trials that may have been only available in certain places before. And because the centres recruit patients at the same time, we accelerate the recruitment and reduce the duration of the trials, sometimes from ten years down to two. There are now 15 approved trials and 10 open for recruitment. We’re absolutely delighted to have announced just last week that the first TAP trial has just successfully completed patient recruitment.
This year the two-year pilot phase of TAP was reviewed by an international panel of blood cancer and solid tumour experts from Europe and the US. The panel were unanimous in their conclusion that TAP has been a great success. Funding for TAP is now as an established programme, rather than a pilot and the renewal contributed to our biggest ever investment in clinical trials.
As well as accelerating the set up and broadening access to trials, TAP is also an important demonstration of a more cost effective way to deliver new drugs. This has been recognised by the National Clinical Director for Cancer Sean Duffy, who said: “I applaud the progress you’ve made from a standing start, and I fully support you in your endeavours.”
TAP has also attracted the attention of the government, umbrella research organisations and pharmaceutical companies. It’s a model that’ll work for all diseases, not just blood cancers, so it could truly revolutionise clinical trials in the UK.
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