ACT and Cure Leukaemia

Accelerating Clinical Trials Ltd (ACT) was established in 2022 to improve the efficiency of the way in which blood cancer trials are conducted and to attract more trials to the UK from global pharmaceutical and biotechnology companies with promising new treatments.

Blood cancer clinical trials are expensive to run. This is largely because they are human resource intensive to meet the regulatory requirements for very close management of patients being treated. There are also significant costs associated with the appropriate labelling and shipping of the medicines involved and the many laboratory tests that are required.

The UK has always been a good place to conduct high-quality clinical trials, being supported by well-trained doctors, nurses, pharmacists and other healthcare professionals within the infrastructure of the NHS. However, over about the last two decades the efficiency of running blood cancer trials showed a decline and led to the reluctance of companies to support trials in the UK. This decline was partly due to regulatory pressures requiring a lot of resource, partly due to the traditional involvement of clinical research organisations that do not specialise in blood cancer and, in a large part due to the absence of dedicated research nurses at trial sites. Finally, there was a lack of coordination between trial sites.

The TAP network of 12 centres was established in 2012, to increase the UK’s capacity and accelerate the delivery of prospective blood cancer trials with promising new drug treatments. IMPACT was launched in 2017 following the success of TAP to run trials aimed at improving outcomes for patients undergoing stem cell (bone marrow) transplants at 11 specialist transplant centres. IMPACT is one of only two stem cell transplant networks in the world.

These two networks of trial centres have a cohesive structure and within each network there is extensive coordination. Importantly the trial sites within these networks were provided with dedicated Cure Leukaemia research nurses. These nurses have been shown to be essential for keeping trials running and on target with respect to the identification of patients eligible for treatment.

Without support from Cure Leukaemia TAP and IMPACT would not have the crucially important research nurses. In its early days, CL raised funds to support the nurses at the TAP sites and helped with funding staff at the former operational hub. Now, with the formation of ACT, CL helps to support the staff who fulfil the hub functions and 27 nurses at both TAP (15 centres) and IMPACT (12) centres.

For the foreseeable future, support from CL will be required to ensure the completion of ongoing trials, to support the portfolio of new trials that are currently being set up and being planned and hopefully to expand the networks.

 

TAP and IMPACT: summary of achievements to date

  • Establishing the TAP resulted in a reduction in the time required to set-up trials from about 30 months to between 8 and 12 months. This is particularly appealing to pharmaceutical and biotechnology companies.
  • More than 1200 patients have been enrolled in 22 trials. The successful completion of several of these trials (some are ongoing) has had a positive effect for many more patients by establishing new treatment strategies for the clinical management of people with Chronic Lymphocytic Leukaemia, Chronic Myeloid Leukaemia, T Cell Lymphoma, Myelofibrosis and for patients with Acute Myeloid Leukaemia who had a recurrence of disease after a stem cell transplant. This message has been further amplified by publishing the trial results in well respected and widely read medical journals.
  • To run these trials, pharmaceutical companies supplied the drugs for NHS patients taking part. This equates to a saving of around £100 million for the NHS.
  • Laboratory studies have generated further insights into biological features of blood cancer cells that influence responses to treatments. This is invaluable for the design of successive trials.
  • The number of TAP centres has increased to 15.
  • The creation of the IMPACT network in 2017 has also led to several benefits in a relatively short period. It’s important to understand that once trials have started and treated the required number of patients, it can take several years of follow-up to assess any overall benefits, so we are still waiting for the final trials results.
  • Seven randomised trials have been opened which together have treated more than 1000 patients to date. These trials have been investigating innovative ways of managing patients with novel drugs and stem cell donor cells to prevent disease recurrence and life-threatening reactions to the transplant.
  • Demonstrating that we can efficiently run randomised trials for stem cell transplant patients has resulted in approaches from companies to run trials for them.
  • There are now 12 IMPACT centres.