Transcript Service user participation in clinical trials

Service user
participation in clinical
trials
Partnership or Co-option?
Dr. Jan Wallcraft
Operational Manager of SURGE
(Service User Research Group for England)
What is service user involvement in
research?
• Seeking out, listening to and acting on the
views and experiences of service users
• and/or working together with service
users at all stages of the research process.
• (NOT to be confused with RECRUITMENT of
research participants/ subjects)
From Involving the Public, INVOLVE 2004
MHRN and SURGE
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Surge’s role is to ensure service user
involvement throughout MHRN and the
projects it adopts
We want to ensure that this is REAL
involvement, not tokenistic
It will take time to build service user
capacity and to create learning
opportunities for clinical researchers
Research participation: why do it?

Service users can provide a valuable perspective
shaped by knowledge of people’s experiences of
health issues and health care that researchers
may not have or may have forgotten
Service users can provide a fresh, interested
“outsiders” look at the work and may bring new
thoughts and ideas to the research process
Service users can help ensure the wording of
documents such as consent forms, information
sheets and reports is understandable to service
users, carers and members of the public
(from: National Programme on Forensic Mental Health R&D – User involvement
induction pack)
What is service user participation in
research?
Many levels - Many Roles
Consultation <-> Collaboration <-> Control
‘We involve service users in trials’
what counts as participation?
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Giving patients in clinical
trials more information?
Asking local service users
to help recruit to trials?
Offering service users
work as researchers?
Consultation on some
aspects of the research –
e.g. methods or
recruitment
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Bringing service user
groups into early planning
of a research proposal?
Inviting service users to
help think about what
should be researched?
Giving service users
resources and support to
run a research project ?
Good practice in participation – the
stages
From ‘Involving the Public’, INVOLVE 2004
SURGE Guidance for Good
Practice key points:
• Be flexible and prepared to negotiate about the
research process
• Deal with differences of opinion with sensitivity and
respect
• Maintain working relationships throughout and after
the end of the project to:• Build for future work. Involve service users in
dissemination Celebrate new learning
Download full report from: www.mhrn.info/surge.html/
Good Practice Guidance
Step by step – Undertaking Research
• Support, supervision and training for everyone
involved is most important
– ( see resource checklist in guidance)
• Consider payment, time & personnel
• Practical, emotional & research support
• Training for researchers and service users
Clinical trials in mental health
4 types or phases
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Phase 1 – basic research
- 1st step trials of new
drugs or treatments
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usually small – up to 30
patients.
Phase 2 – basic research
2nd step: Does the new
treatment work well
enough for full scale
comparison with existing
treatments?
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Up to 50 patients. Looking
for what type of problems
it helps and for side effects
and correct dosages
Phase 3 – comparison of
new treatment with
standard treatments
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may be 1000s of patients
in trial
usually randomised
controlled trials
Phase 4 – trials done on
drugs already shown to
work
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to find out more about
safety and long-term risks
how does the treatment
work in wider more general
use – outside clinical trials
MHRN and the pharma industry
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Mental Health Research Network has been told it
must work with the pharma industry and take on
trials of drugs – probably phase 3 & 4 type
large-scale trials – (not basic research step 1&2)
Key issues for the pharma industry are speed of
access to patients and reduction of ‘red tape’
MHRN is seeking ways to work with pharma
companies without compromising its standards
of research governance
Service users’ views on working
with pharma companies
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On Our Own Terms research
showed that more than a third
of service users would consider
drug company funding if the
circumstances are right, e.g:
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If the drug company puts all
its cards on the table and the
deal is acceptable
If the group is desperate for
funding for a good purpose
and there is no other
alternative
If the drug company is
committed to ethical research
principles
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However, a larger proportion,
nearly half, were opposed to
funding from pharma
companies
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‘drug companies are not going
to want to talk about
alternative therapies, are
they?’
‘it doesn’t seem right to me,
but it’s a personal decision’
‘to accept money would be to
give legitimacy to the drug
companies’ views on chemical
imbalances, so I wouldn’t find
it acceptable’
On Our Own Terms: download from www.scmh.org.uk publications
Can participation work?
From Involve 2004
From Involving the Public, INVOLVE 2004
Can the relationship with the
Pharma industry work?
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Preconditions:
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Industry studies to be
judged on same criteria as
other studies (though
procedures may be
speeded up)
Service user involvement
on Adoptions Committee
for pharma studies
MHRN will discuss with
Medicines Regulatory
Authority the rules for
service user involvement
with pharma industry
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SURGE to
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ask service users for
suggestions to improve
clinical trial procedures –
e.g. how to make
involvement effective and
trials more service-user
friendly
MHRN to
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look at ways to bring in
service user values into
outcome measures for
clinical studies
Hopes for the future of participation
in research: an optimistic scenario:
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Service user participation
will lead to all clinical trials
(including pharma industry)
being submitted for
approval to committees of
well-trained, experienced
service users at the
concept stage
New research methods and
measures will be developed
with service user
participation
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No clinical trial will be
acceptable unless its
methods and outcome
measures reflect service
user values e.g.
 low risk to participants,
 good information
 choice, selfmanagement, and
recovery goals
Money and support will be
made available for largescale service-user led
research
The Answer!
Involve Newsletter Autumn 2005