Slide 1

Report
Clinical Research at Harrogate
Foundation District Trust
Medicine for Members
15th July
Clinical Studies
Study Initiation
& Approval
Patient
Screening
Taking Research Forward in the NHS –
Dr Alison Layton
Patient Screening in Cancer Research Nicky Thomas
Consent
Consent and Information Governance in
Research – Kate Gunn
Study Baseline
Baseline Data in Dermatology Research –
Margaret Broome
Study
Participation
Patient Participation in the PHACS Cardiology
Study – Carol Bagshaw & Malcolm Wood
Study
Outcomes
What has research ever done for us? Maggie Peat
Taking research forward in the NHS
Dr Alison Layton
Consultant Dermatologist, HDFT
Clinical Director North East Yorkshire & North
Lincolnshire CLRN
AIMS – Share National Perspective
•
•
•
•
Why we believe is research important
How research is being supported
Demonstrate the impact of research
Public and Patient involvement
– How could you help?
Why do we
need research
in the NHS?
Health
Wealth
Policy
Delivers more R&D
in the NHS
Health
Clinical Research Studies benefit the NHS because they:
Improve patient care
Establish innovation
Stimulate recruitment
and enrich jobs
Wealth
Clinical Research Studies benefit the NHS because:
Importance of life
sciences sector
Employment
determines health
Additional income
Policy context
Office for Life
Sciences
NHS Life Sciences
Innovation Delivery
Board
White Paper
How is research being supported?
Supports
facilities for
research
(e.g.
Biomedical
Research
Units)
National Institute for Health
Research
The Clinical Research
Network:
Provides the practical support
researchers need to run
clinical studies in the NHS,
so that more studies can
happen, and more patients
can take part
Commissions
and funds NHS
and social care
research
Trains and
develops
researchers
The Context
NIHR Clinical Research Network
Coordinating Centre (NIHR CRN CC, formerly UKCRN)
6 Topic Specific
Clinical Research Network
Coordinating Centres:
•
Diabetes (DRN)
•
Dementias and Neurodegenerative
Diseases (DeNDRoN)
•
Cancer (NCRN) - 2001
•
Medicines for Children (MCRN)
•
Mental Health (MHRN)
•
Stroke (SRN)
Primary Care
Research
Network
Comprehensive
Clinical
Research Network
(PCRN)
(CCRN)
25 Comprehensive Local
Research Networks
CLRNs
NEYNL CLRN
North East Yorkshire and North Lincolnshire
Comprehensive research network (1 of 25)
Population 1.7m
Budget £6m (2011-12)
NIHR Research Categories
SPECIALTY GROUPS
Age and ageing
Anaesthetics
Haematology
Cardiovascular
Clinical Genetics
Critical Care
Dermatology
ENT
Gastrointestinal
Health Services Research
Hepatology
Infection
Inflammatory and Immune
Injuries and Accidents
Metabolic and Endocrine Musculoskeletal
*Neurological
Ophthalmology
Oral and Dental
*Paediatrics
Public Health
Renal
Reproductive Health
Respiratory
Surgery
Urogenital
+ Palliative Care et al
The importance of the networks...
Help to improve treatments for patients
Help medical professionals to offer patients
research as part of treatment options
Help the NHS to focus resources on “what
works”
Help NHS Trusts to deliver the quality and
innovation agenda
Enable NHS Trusts to benefit from income
generated by research activity
IT IS CORE BUSINESS – NHS constitution
commits to promotion and conduct of research
What does “practical support” mean?
• Reducing the red-tape around setting up a study
• Funding additional people (e.g. research nurses) and
facilities needed to support research
– “on the ground” so research activity does not use core
NHS resources
• Helping researchers to identify suitable NHS sites to
identify and recruit patients
• Advising researchers how to make their study “work” in
the NHS environment
The ultimate goals:• To support research and change the
culture
• embed research within every day
practice
• Provide evidence based medicine
• Improve patient care and the NHS
• Potential health and economic
advantages
How are we performing?
• We recruited more than half a million patients into high
quality clinical studies last year
– Increased treatment options for those patients
– Helped patients to participate in improving care for
others in the future
• At this point, we are helping researchers to recruit
patients to more than 2,400 studies
– Researchers more confident that they can complete
their studies on time, and on patient target
England NHS strategic health authority (SHA) recruitment analysis 01/04/10 - 31/03/11
160000
150535
140000
120000
100000
80000
78074
(blank)
West Yorkshire CLRN
60000
50986
40000
49711
48710
South Yorkshire CLRN
45511
23617
20000
N&E Yorkshire & N Lincs CLRN
41035
32758
30019
20744
13010
13084
0
NHS London NHS North NHS South
West
West
NHS
Yorkshire
and the
Humber
NHS South
Central
NHS West NHS East of
Midlands
England
NHS East
Midlands
NHS North NHS South
East
East Coast
Baseline Patient Recruitment - Comparison by year
14000
13084
12960
12000
10000
8812
8000
7680
6000
4000
2000
0
Apr
May
Jun
Jul
2008/2009
Aug
2009/2010
Sep
Oct
2010/2011
Nov
Dec
2010/2011 Target
Jan
Feb
Mar
How are we performing
• Increasing the involvement of the industry in NHS
research, which helps to bring new and better treatments
to our patients earlier
– 639 “industry” studies currently supported
– Renewed confidence in the UK as a research locality
from companies such as Novartis
What has been achieved:
Helped researchers to
prove that a new
vaccine provided
better protection for
children against
pneumococcal
disease.
The vaccination
programme for all
children in England
has changed as a
result.
Results
Helped
researchers to
show that
radiotherapy
before rectal
cancer surgery
lowered the
chances of
cancer
returning.
40% of
surgeons now
follow this.
How could you help?
• Participation
– Active involvement
– Identifying research questions
– Helping with research protocols
• Increase awareness
– Appointment letters
– Posters
– Newsletters
• Consent register
– Dementia and Neurodegenerative disease
We need your help and ideas!
How to find out more
• Visit the website:
www.crncc.nihr.ac.uk
• Sign up to our
quarterly e-newsletter
to find out more about
our research activity
(from the website
home page)
Screening in Research
Nicky Thomas
Cancer Research Nurse
Multi-Disciplinary Team
Consultants
Nurse specialists
Histopathologist
Radiologist
Surgical team/ medical team
Oncologists
Video-link / York or Leeds
Research Nurse
Match Each Patient to a Clinical Trial
Personalising cancer treatment
Why Screen?
 Screening provides Quality Assurance to the
results
 We need reliable, valid and consistent results
 From research that was performed under the
same conditions
Eligibility
Inclusion/Exclusion Criteria
Patient Information
Meeting & discussion with patient is very important
Written information about trial is given to patient
Time is given to the patient to consider all their
options and to discuss with their family/friends
RESEARCH IS VOLUNTARY
Driving up the Quality of Care for Our Patients
Choices of
treatment
Empowering
the patient
Equality and
excellence
Information Governance
and Consent within Research
Kate Gunn
Research Administrator
Why are Information Governance
Checks Necessary?
 To safe guard participant’s data
 To ensure participant’s are fully aware of how
their data will be used
 To ensure the participant’s consent will cover all
usage of their data
 To ensure that studies demonstrate data
protection policies that match the Trust’s policies
 To ensure that studies are staying within the Data
Protection Act
Keeping to High Standards of
Information Governance
By keeping to high standards of information
governance we:
 Safe guard participants taking part in research
studies
 Protect researchers/investigators
 Enhance ethical and scientific quality
 Minimise risk
 Promote good information governance practice
Information
Governance –
Consent Form
Consent within Research
Today patients have a choice, but it was not
always the case




1900 Prussian Regulations
Nuremburg Code
Helsinki Declaration
ICH-GCP
Legislation was developed to protect patients
taking part in clinical trials
So What is Informed Consent?
How Long Does a Patient Have to
Make a Decision?
What about Consenting Minors?
CONCLUSION
By Gaining “Informed Consent” We:
 Ensure that we are following the International
regulations governing clinical research
 Ensure that participants understand the full
extent of their commitment
 Help to ensure that excellent data can be
collected and analysed
 Help to ensure that any research studies we are
involved in at Harrogate are conducted to the
highest possible standards
Baseline Data
Margaret Broome
Wound Care Research Nurse
Baseline data - What is it ?
 Information
gathered from a patient prior to any
study intervention that defines the status of the
patient at that time
 Information is collected once the patient has
been matched & found to be eligible for the study
 Written consent should have been given by the
patient prior to any data collection
How is it collected and who collects it?
 Patient
interviews
 Questionnaires
 Physical
examinations
 Laboratory
tests
 Imaging
 Observation
 General/
 Medical

study specific
staff
Research nurses/staff
VenUS IV Study
 As a Research Nurse with a background in wound
management, I tend to be involved wounds studies
 Currently involved in VenUS IV study which
requires both general and specific baseline data
Baseline
Assessment for
VenUS IV Study
Baseline Assessment for VenUS IV study
Baseline Assessment for VenUS IV Study
Summary
 Describes study group
 Influence of certain characteristics
 Promotes reliability and validity
 Shows a balanced study
 Can assist in further studies
Study Participation
Pharmacogenetics of Acute
Coronary Syndrome (PHACS)
Carol Bagshaw,
Cardiac Research Nurse
& Mr. Malcolm Wood
PHACS patient
Carol Bagshaw 07/07/2011
Pharmacogenetics
Is the study of how your genes affect the way
your body responds to a medicine
Acute Coronary Syndrome (ACS)
Heart Attack
(myocardial infarction)
Medications
ACE Inhibitor
Beta Blocker
Aspirin
Clopidogrel
Statin
Angina
Patient Journey






Diagnosis
Approach, information
Visit 1 Consent, samples and patient diary
Visit 2 samples and questionnaires
Visit 3 samples and questionnaires
Visit 4 case note review
Study Outcome




Future
Treatment
Benefits
Better understanding of the side effects
Personalised Prescriptions
Eventually it is hoped that each
patient’s treatment for ACS will be
tailored to their genetic profile
Study Outcomes
What has Research Ever Done for Us?
Maggie Peat
Senior Research Nurse
It’s Not Just About New Treatments
Out of 115 studies recruiting patients at the
Trust less than 10% involve ‘new’ treatments
 some are old treatments in new situations
 some are old treatments which have been
used alongside each other for some time
 some are observational studies
 some are registries
 and so on……
What has Research Ever Done for Us?






Improves patient care
It saves time
It saves public money
It can make care safer
It finds new uses for old treatments
It can give patients more treatment options
It saves time…
 CLOTS 1 study
 ‘Common sense’ approach
 Anti-embolism stockings standard after stroke
 Trial – 2518pts (75 from Harrogate), randomised
to stockings or no stockings
 Stockings did not reduce risk of DVT & increased
skin lesions (blisters, skin breaks, ulcers)
 Estimated saving of 320,000 hrs of nurse time
The Lancet, Volume 373, Issue 9679, Pages 1958 - 1965, 6 June 2009
It saves public money…
 CLOTS 1
 Estimated saving of:
£4 million
annually
It can make care safer…
 Corticosteroids for severe head injury
 ‘Common sense’ approach
 CRASH study (2007)
 Trial – 20,000 patients, 239 ICUs, 49 countries
allocated to methylprednisolone or placebo
 No positive long term effect for steroid group
 Trial stopped after 10,008 recruited as
significant increase in death within 2 weeks
(steroid 21.1%; placebo 17.9%)
www.thelancet.com Vol 364 October 9, 2004 1321-1328
It finds new uses for old treatments
 ISIS 2 - reported 1988
 17,187 patients, 417 hospitals in 16 countries
 Aspirin has a significant impact on mortality
after acute myocardial infarction
 So beneficial & side effects so minimal in
comparison - virtually anyone suspected of
having a heart attack should be given it
Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of
suspected acute myocardial infarction: ISIS-2. ISIS-2 (Second International Study of Infarct Survival)
Collaborative Group. Lancet 1988;2:349-60
Aspirin - wonder drug
 Subsequent MI, stroke or vascular death reduced
by 25%
 Deaths from any cause reduced by one fifth
 1000 patients – 40 deaths, MIs or strokes
prevented in 1st month, 40 more over next 2 years
 The prompt treatment of suspected MI patients
with aspirin will save the life of 1 in 40 patients
It finds new uses for ‘bad’ drugs
Thalidomide can be used to treat:
 Leprosy – licensed in 1998 (found to be
effective in mid 1960s)
 Multiple myeloma
 HIV related mouth & throat ulcers &
Kaposi’s sarcoma
 Inflammatory diseases such as arthritis
 Stopping growth of cancers
Kaposi’s
sarcoma
So it’s worth doing…
……even if or especially when it shows that
something doesn’t work!
Department of Health has recognised this and
boosted funding for research
‘research and innovation (by academia, charities,
businesses and the NHS) are vital to the
continuous improvement of quality in the NHS’
Government response to ‘NHS Future Forum’ 20th June 2011
http://www.nihr.ac.uk/about/Pages/Government_response_to_NHS_Future_Forum.aspx
And it has worked!
Here at HDFT:
 115 studies
 2108 patients recruited April to April 2010/11
 78 research clinicians, research nurses & staff
Patient Recruitment
2500
2106
2000
Apr 08-09: 167 patients
1500
Apr 09-10: 622 patients
1000
500
Apr 10-11: 2106 patients
622
167
0
April 08-09
April 09-10
April 10-11
Patient recruitment
Patient recruitment per 10,000 population
served by Acute NHS Trusts
100
90
91
80
70
60
50
40
39
39
34
30
30
27
20
10
0
Harrogate And
York Teaching
District NHS
Hospital NHS
Foundation Trust Foundation Trust
Hull and East
Yorkshire
Hospitals NHS
Trust
Northern
Lincolnshire and
Goole Hospitals
NHS Trust
Scarborough and
Humber NHS
North East
Foundation Trust
Yorkshire Health
Care NHS Trust

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