We provide core funding for seven Clinical Trials Units (CTU) across the UK. These are specialist research units that have expertise in coordinating clinical trials, including their design, management and data analysis. In this update we hear directly from our trials units at the Institute of Cancer Research in London and in Southampton.
The Institute of Cancer Research (ICR), London, is one of the most influential cancer research institutes. Through its unique partnership with The Royal Marsden NHS Foundation Trust, The ICR is able to create and deliver world-leading results. Together, the two organisations are rated in the top four global cancer centres.
Led by Professor Judith Bliss (pictured), we work with nationally and internationally based clinicians, scientists and CTUs to design, conduct and analyse multi-centre, randomised trials intended to directly influence routine clinical practice.
Our main focus is on new ways of delivering tailored cancer care. Our interests and areas of expertise are phase II and III randomised trials that evaluate new technologies, treatments or predictive biomarkers with a focus on breast, urological and head and neck cancers and, increasingly, rare tumours.
The ICR-CTSU has an emerging portfolio of molecularly stratified, targeted treatment trials. We also run trials in rare cancers requiring international collaboration and new collaborations with local early-phase Experimental Cancer Medicine Centre (ECMC) studies.
• The START trials (published in Lancet Oncology and Lancet), tested hypofractionated breast radiotherapy and have informed practice in the UK (NICE Guidance 2009) and internationally (ASTRO guidelines 2011)
• The IMPORT trials testing tailored breast radiotherapy according to risk of relapse have necessitated innovative radiotherapy planning (published in International Journal of Radiation Oncology) and have led to improvements in routine practice (BASO guidelines 2009)
• BC2001, testing synchronous chemo-radiotherapy in bladder cancer, has resulted in chemo-radiotherapy being adopted as standard by many UK hospitals (published in New England Journal of Medicine)
• PARSPORT, which tested intensity-modulated radiotherapy (IMRT) in pharyngeal cancers, contributed to IMRT being adopted as the treatment of choice in North America, Europe, China and Asia (published in Lancet Oncology)
The ICR-CTSU is core-funded by Cancer Research UK, NCRI accredited and UKCRC registered.
Our aim is to improve outcomes for people with cancer by delivering high-quality, robust clinical trials which are innovative in design and method of treatment used and which address important clinical questions.
This year we complete five years as a trials unit and we currently have 44 members of staff. We specialise in the design and conduct of cancer trials of Investigational Medicinal Products (IMPs) and surgical interventions and deliver innovative trial designs particularly in the areas of haematological oncology, gastrointestinal cancers and urological malignancy.
We are located close to the Research Design Service and have a close working relationship that facilitates early discussions around trial design and peer review particularly at the early pre-submission stages. This ensures that our investigators have the benefit of clear advice and support at each stage from concept to funding application submission. At the last Clinical Trials Awards and Advisory Committee meeting, all three of our trial submissions were approved for funding.
In common with other Cancer Research UK core funded trials units, we underwent a successful review by an international panel of experts who particularly commended our operational standards including the implementation of an industry standard database allowing remote electronic data capture. We were also highly commended for our inclusion of clinical research training fellows in the day-to-day activity of the unit over the past year and going forwards. This has been beneficial to CTU staff and aims to build well-informed clinical trial research capability amongst the oncologists of the future.