National Colorectal Cancer Nursing Network
Tuesday 11th October 2011
Clinical Research and the Role of the CNS
Sarah A M Crane
Chief Executive
Pelican Cancer Foundation
BASINGSTOKE
Advancing precision surgery
Pelican Cancer Foundation
Registered Charity
Our aim is to improve precise treatment,
particularly surgery, for bowel, liver,
bladder and prostate cancers
Advancing precision surgery
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
Advancing precision surgery
Should we do research
Claude Galen 122-199
19th Century
Advancing precision surgery
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.
Advancing precision surgery
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
Advancing precision surgery
“Wanted – volunteers for
randomized, placebo controlled trial
Does a parachute prevent gravity?
Advancing precision surgery
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
Advancing precision surgery
Observational Study
Deferral of Surgery
 We aim to demonstrate that rectal surgery can be
safely delayed or avoided in a carefully
selected group of patients after chemoradiotherapy. 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.
Advancing precision surgery
Advancing precision surgery
Role of the CNS
How do you feel about
research?
Who should do research?
Advancing precision surgery
Teamwork from start to finish
Advancing precision surgery
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?
Advancing precision surgery
Why do research
Patient benefit
Confirming practice
Part of the NHS operating framework
(priorities)
Innovation – World Leaders!
Financial return - £1 adds 39p pa
Advancing precision surgery
Advancing precision surgery
Why do research
That’s funny!
Experience
Listening
Patient benefit
Bias
Time
Advancing precision surgery
The patient’s dilemma
Equipoise
What evidence?
Pros and Cons
Who can participate?
Bias
Late effects
Advancing precision surgery
Advancing precision surgery
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
Advancing precision surgery
A New Era
Dame Sally Davies
NIHR
Clinical Research Network
Funding
Oversight
Advancing precision surgery
UKCRN Portfolio
Nationally advertised
External peer review
Internal peer review
Conflict of interest
Report on results
= National portfolio
= NHS support costs
Advancing precision surgery
http://public.ukcrn.org.uk/search/
Advancing precision surgery
Colorectal Clinical Trials
Currently on the UKCRN portfolio
Study Status
Disease
In set-up Recruiting
Closed /
Suspend Now
ed
Anus
0
0
4
0
Appendix
0
1
0
0
Colon
4
47
58
51
Rectum
4
39
51
43
Advancing precision surgery
Colorectal Research
86 trials are open on the portfolio
Breakdown
 10 colon only trials – 2 interventional
 8 rectal only trials - 8 interventional
Advancing precision surgery
Advancing precision surgery
Number of studies in each
Specialty Group
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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
Advancing precision surgery
Money
Activity based funding
CCRN Indicative Budget Allocation 2010
Birmingham
Central and East and Hertfordshire
Hampshire and Isle of Wight
London (North West)
London (South)
£12,896,800
£6,944,700
£9,651,400
£11,363,821
£18,100,000
Advancing precision surgery
Advancing precision surgery
Summary
The question
Equipoise
Resources
Teamwork
Caseload
Advancing precision surgery
Advancing precision surgery
Clinical Research and the Role of the CNS
SARAH CRANE
PELICAN CANCER FOUNDATION
Telephone: 01256 314746
www.pelicancancer.org
Advancing precision surgery