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National Colorectal Cancer Nursing Network Tuesday 11 th October 2011 Clinical Research and the Role of the CNS. Sarah A M Crane Chief Executive Pelican Cancer Foundation BASINGSTOKE. Pelican Cancer Foundation. Registered Charity
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National Colorectal Cancer Nursing NetworkTuesday 11th October 2011Clinical Research and the Role of the CNS Sarah A M Crane Chief Executive Pelican Cancer Foundation BASINGSTOKE
Pelican Cancer Foundation Registered Charity Our aim is to improve precise treatment, particularly surgery, for bowel, liver, bladder and prostate cancers
How we do it • Colorectal and specialist courses - live surgery National Programmes (MDT -TME/LOREC/Lapco) • Meetings – Hepatobiliary, Colorectal, Prostate • Research – member of AMRC, NIHR partner organisation, independent scientific panel chaired by Lord Ribeiro
Should we do research Claude Galen 122-199 19th Century
Clinical research • Clinical research is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease.
Types of research • Randomised control trial (RCT) • CReST - • For patients presenting acutely with obstructing left-sided colorectal cancer will be randomised between emergency surgery or endoluminal stenting. • Birmingham trials unit
“Wanted – volunteers for randomized, placebo controlled trial Does a parachute prevent gravity?
Types of research • Randomised Observational study/ pragmatic design • Timing of Surgery after preoperative radiotherapy 6 vs 12 weeks • Is greater down-staging and tumour regression observed when surgery is delayed to 12 weeks after the completion of chemoradiotherapy versus 6 weeks? • Cancer Backup information for patients
Observational Study • Deferral of Surgery • We aim to demonstrate that rectal surgery can be safely delayed or avoided in a carefully selected groupof patients after chemo-radiotherapy. Our primary objectives are to show that at least 10% of patients with an excellent response to chemo-radiotherapy are able to safely avoid surgery, and to assess the safety of deferral of rectal surgery until time of maximal tumour response.
Role of the CNS • How do you feel about research? • Who should do research?
What research? • Is there a question? • Do you understand the question? • Do you want to know the answer? • Do you believe it will help your patients? • Is there equipoise • Do you have a strong clinical lead?
Why do research • Patient benefit • Confirming practice • Part of the NHS operating framework (priorities) • Innovation – World Leaders! • Financial return - £1 adds 39p pa
Why do research • That’s funny! • Experience • Listening • Patient benefit • Bias • Time
The patient’s dilemma • Equipoise • What evidence? • Pros and Cons • Who can participate? • Bias • Late effects
UK role in commercial research • Pfizer – UK is not a core country for research • GSK – UK only qualifies for oncology research • 50% delays to enrolment • 70% sites fail to recruit target • 35% sites fail to recruit ANY patients • Drugs take 9 – 14 years and cost £1.5B
A New Era • Dame Sally Davies • NIHR • Clinical Research Network • Funding • Oversight
UKCRN Portfolio • Nationally advertised • External peer review • Internal peer review • Conflict of interest • Report on results • = National portfolio • = NHS support costs
Colorectal Research • 86 trials are open on the portfolio Breakdown • 10 colon only trials – 2 interventional • 8 rectal only trials - 8 interventional
CCRN Comprehensive Clinical Research Network ‘to widen participation in research and ensure that patients and healthcare professionals from all parts of the country are able to participate in, and benefit from, clinical research in all areas of disease and healthcare • CLRN Comprehensive Local Research Networks • Facilitate streamlining of R&D process. Support for planning, set-up and delivery of studies. ↑ number of studies ↑ collaboration within networks • NCRN National Cancer Research Network • ‘to improve the infrastructure within the NHS for clinical research in cancer and to ensure that research is better integrated with cancer care http://www.nihr.ac.uk
Money • Activity based funding • CCRN Indicative Budget Allocation 2010 Birmingham £12,896,800 Central and East and Hertfordshire £6,944,700 Hampshire and Isle of Wight £9,651,400 London (North West) £11,363,821 London (South) £18,100,000
Summary • The question • Equipoise • Resources • Teamwork • Caseload
Clinical Research and the Role of the CNS Sarah CranePelican Cancer Foundation Telephone: 01256 314746 www.pelicancancer.org