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Leukaemia & Lymphoma Research. Founded in 1960 £32M research commitment in 2012-13 The object for which LLR is established is the advancement of health and the saving of lives by:
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Leukaemia & Lymphoma Research • Founded in 1960 • £32M research commitment in 2012-13 • The object for which LLR is established is the advancement of health and the saving of lives by: • Promoting and assisting research into all aspects of blood cancers including the causes, diagnosis, treatment and cure of all blood cancers; and • Advancing the public understanding of blood cancers
The LLR and Stem Cell Transplantation • £7.6M Currently invested in HSCT related research • CTRF • 6 trials • TARP • 6 projects • 4 Specialist Programmes
The Need • The majority of adults with blood cancer die of relapsed or resistant disease. • Pipeline of targeted drug or transplant options urgently require assessment • Compared to Phase III trials in haemato-oncology the UK track record in early phase trials has been modest. • Absence of a co-ordinated networks with large enough catchment to allow rapid recruitment • The strategic advantage of a centrally imposed structure (NHS) has not been exploited
Trials Acceleration Programme (TAP) Central Coordination Hub to manage TAP early phase trials PI Charlie Craddock A funded network of early phase leukaemia centres: Serving metropolitan areas within the UK-covering catchment area of >20 million Dedicated research nurses and data managers
TAP Network - aims • To open 4/5 new trials each year • Open within 6 months • Recruit in timely fashion • To strengthen translational studies • To complete, analyse and publish results two years after recruitment of first patient • To achieve a steady state of 10/15 trials recruiting upwards of 700 patients over 3 years • Secure the future of Haem Onc trials in the UK
Translational Work • Trials specific work • Biobanking (where available)
Cancer Research UK Clinical Trials Unit (CRCTU) University of Birmingham NCRN Accredited, NIHR Registered Builds on LLR ‘s investment in early phase haematology trials TAP Central Coordination Hub
TAP Central Coordination Hub • Statistical design • Regulatory approvals • Contracts & sponsorship • Site initiation • Trial management • Programming • Monitoring • Analysis • Publication
Progress • Award made in to establish hub in 2011 • Centre awards made in 2012 • Fully operational April-May 2012 • 16 applications processed • 12 accepted, 3 rejected, 1 withdrawn • Several other studies being developed • 4 trials open and recruiting well • Anticipate the opening of 5-7 more by spring 2014
Trials Acceleration Programme (TAP) *Southampton General Hospital, Barts Hospital London, The Christie Manchester, King’s College London (King’s Guy’s, St Thomas’), St James’ University Hospital Leeds, Queen Elizabeth Hospital Birmingham, Hammersmith Hospital London, Belfast City Hospital, Gartnavel General Hospital Glasgow, Royal Liverpool University Hospital, Churchill Hospital Oxford, Cardiff University Hospital, Nottingham University Hospital
Industry • Novartis • Merck • Celgene • Millennium • Gilead • Pharmacyclics • GSK • Ariad
Novartis Feedback • Where TAP meets Novartis needs • Speed • Productivity • Recruitment • Costs • Trial access for patients • Patient access to treatment post study • Quality
Other boxes ticked • Government drive to improve research environment in the UK • Reducing red tape for clinical trials
Policy Impact • TAP policy dinners at Speakers House • Case Study in ‘Strategy for UK Life Sciences; One Year On’* • House of Lords Science and Technology Committee report Regenerative Medicine** • Case study ABPI/AMRC roundtable event at the Conservative Party conference 2013 * https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/36684/12-1346-strategy-for-uk-life-sciences-one-year-on.pdf ** http://www.publications.parliament.uk/pa/ld201314/ldselect/ldsctech/23/23.pdf