Leukaemia & Lymphoma Research is funding its Trials Acceleration Programme (TAP) for a further five years up until 2020. TAP is an exciting new initiative to deliver excellent research on potentially life-saving drugs and treatments to the benefit of all blood cancer patients. The initiative was set up in 2010 but was operational in earnest in 2011. In just over two years, seven trials ave opened and eight more are in the pipeline.
The need for TAP
Clinical trials in the UK, particularly in blood cancer are notoriously difficult to set up and can be slow to deliver results. Currently it can take anything from four to ten years to complete a trial and analyse the results.
This is for a variety of reasons. One is a lack of staff resources in hospitals to manage the trial paperwork and additional patient care. Another is the bureaucracy involved in getting new studies off the ground – for example who can join the trial, the schedule and doses of treatment, and how long it will take.
Another important issue is that blood cancers, taken as individual diseases are relatively rare (see here). As trials have very specific patient requirements, like type of disease, age and general health, it is often difficult for a single hospital to recruit enough patients onto a trial. Some trials are never even completed.
TAP aims to boost the number and speed of early stage clinical trials, testing promising new therapies and diagnostics. It's a crucial link between the discoveries made in the lab and the new treatments patients receive.
How TAP works
TAP is based on a hub-and-spoke model, with a central coordinating team at Birmingham (see here) and 13 recruitment centres around the UK. Dedicated, expert staff at the hub – including trial coordinators, data analysts and statisticians – take a clinical investigator's idea from concept to a suitably designed clinical trial, negotiating all the tricky but essential administration along the way. And when the trial starts, the 13 research hospitals with large catchment areas act simultaneously to recruit patients (See our earlier post: Trials Acceleration Programme)
Over 300 patients have been recruited to these early stage trials that probably wouldn't have happened without TAP. When all these trials are finished, this total will be around 950 patients.
TAP has centres all round the UK, including north and south England, Wales, Scotland and Belfast (see map on the right)
Pilot to Programme
To move TAP from its pilot phase to this new permanent five- year programme, the Research team at Leukaemia & Lymphoma Research convened a panel of world-renowned experts based in the UK and overseas to assess TAP. The panel included an extensive range of expertise, from blood cancer and solid tumour trialists, to pharmaceutical drug development, NHS and UK health policy.
The panel came together in May this year and comprehensively evaluated the programme and its performance. The process was invaluable for learning what's worked and what can be improved.
The panel was very impressed by the TAP network overall and saw it as an excellent model for an early phase trials network for complex cancers. It was unanimous in recommending the continuation of TAP for the next five years and praised TAP for recruiting the desired number of patients to trials in the allocated time – a notorious stumbling block for these kinds of trials.
The panel was also very enthusiastic to hear that some trials, for example in chronic lymphocytic leukaemia, are set to influence the design of later stage clinical trials – the ones that ultimately change clinical practice.
The panel also highlighted the use of innovative trial design in TAP, which has also been recognised by the award of presentations at leading scientific conferences both in the UK and USA, and the ripples in the policy arena that TAP has already made:
TAP will continue to collect patient samples from the trials to support further discovery lab work, which is crucial to understanding why some patients respond to a treatment and why some don't.
And we will look to collect and disseminate lessons and experiences in running a clinical trial network, so that our influence on blood cancers and beyond is far and wide.
The future’s bright
So from January 2015, TAP will enter a bright new era. The hub will be funded with an investment of £5 million for five years (with the latter two years dependent on satisfactory performance at an interim assessment). The centres will be funded for two years initially, at a cost of £1 million. At this point a review specifically of the centres will be carried out and successful centres will be funded for a further three years at an additional cost of £2 million to bring them in line with the hub support.
This means TAP can finish all the trials that are ongoing, and set up even more studies to test exciting new therapies and diagnostics. And it’s worth remembering, that once this infrastructure is in place, many trials can be delivered at no additional cost.
A big long-term investment for big patient impact.