A lot of our efforts are geared towards finding new treatments to beat blood cancers. Before becoming widely available, any novel agents must be first tested in ‘early phase’ clinical trials. These are where promising new drugs are given, usually in small doses to start with, to a few patients – typically fewer than 100. This lets doctors see what the safe dose range is, whether there are any side effects and whether there is any indication that it works against the cancer. Once a drug has passed these tests, it’s ready to be compared in larger trials against the current standard treatment to find out whether it should be used routinely in the clinic.
It's a process all new therapies have to go through before being licensed for broader use and is an important way that patients can access pioneering new therapies before it’s too late. But currently, only a minority of blood cancer patients have access to clinical trials, similar to cancer patients in general.
So what is stopping many blood cancer patients getting onto early clinical trials?
Setting up trials requires staff with know-how and, as you can imagine, lots of paperwork. A trial may also need commercial or other charity partners to come on board, and then doctors have to work within the NHS structures to recruit many patients to take part. It can, as a result, take anything from four to ten years to complete a trial and analyse the results. Largely because of the legislative hurdles, there is a bottleneck in getting innovative blood cancer treatments tested in early phase clinical trials.
To tackle this problem, Leukaemia & Lymphoma Research launched the Trials Acceleration Programme (TAP) in 2011. This formed a coordinated network of clinical trial centres with large enough catchment areas to allow rapid recruitment of patients to early phase clinical trials. And we’re thrilled to be able to extend this groundbreaking pilot initiative until at least the end of 2014, when we’ll look again at its success.
The TAP network is made up of 13 leading hospitals around the UK, supported by a central hub at the University of Birmingham. A key advantage of this set-up is that there is a dedicated team in Birmingham – trial coordinators, statisticians, data managers, research nurses – to deal with all the administration associated with getting trials set up and analysed. It's a bit like a queue jumping ticket: TAP aims to get blood cancer clinical trials completed within two years. What’s more, by making the machine more efficient, we can increase its capacity – this means more trials and more exciting drugs can be tested.
In addition to the 13 centres, many more sites around the UK can participate by recruiting their eligible patients to a TAP trial. This is another major strength of TAP – because individual blood cancers are relatively rare and as more sub-types are identified, it's often difficult for a single hospital to recruit enough patients onto a trial and confidently show that a treatment works. By tapping into a larger trials network, doctors can get emerging treatments to their patients earlier and we can demonstrate a therapy's effectiveness sooner. It really is more than the sum of its parts.
Since July 2011, we have supported 11 trials through this programme and more are in the pipeline. These trials tackle a range of blood cancers, including acute myeloid leukaemia, myeloproliferative neoplasms, chronic lymphocytic leukaemia, Hodgkin lymphoma, chronic myeloid leukaemia, myelodysplastic syndromes and T-cell lymphoma. This is a fantastic rate of set-up, and now the focus for the next 12 months is to recruit as many blood cancer patients as possible. By doing this,
On the MAJIC trial – the first one in TAP and open from August 2012 – Sonia Fox, Senior Trial Coordinator at the University of Birmingham Hub said:
"MAJIC is the first academic trial in the world to use [the promising drug] Ruxolitinib and has proved popular with hospitals across the UK, with many sites wanting to take part due to the limited availability of Ruxolitinib outside of clinical trials. Twenty nine hospitals have been opened to recruitment and we have just randomised our 100th patient – all within the first 12 months of opening! This is a fantastic achievement and represents a major step forward in research into myeloproliferative disease."
The power of TAP has also been recognised nationally, garnering the attention of government officials, senior MPs, the pharmaceutical industry and national bodies within the medical research community. The investigators on some TAP trials have even received interest from European colleagues, which in future could broaden TAP’s impact across the continent. This may present an extra hurdle, however – one of the factors that makes TAP possible is that, in this country, we have a joined-up National Health Service that facilitates clinical networks.
But not only is it bringing immediate benefits to blood cancer patients, it has the potential to lead the way and change the way the UK runs all clinical trials. Barbara McLaughlan, Head of External Affairs, Oncology at Novartis Pharmaceuticals UK, also involved with MAJIC, said:
"As one of the first pharmaceutical companies who invested in a trial run through TAP we have put on record on a number of occasions and in different contexts the positive impact that this initiative has had on three key factors that influence our trial placement decisions: Set-up time; speed of patient recruitment; and, cost. Because of this success Novartis is keen to see the continuation of the TAP initiative and would welcome an extension of the concept behind TAP to other disease areas with a view to establishing it as standard practice."
There’s more to come in the next year – more trials, more patients and more new treatments – so watch this space.