Service user participation in clinical

trials

Partnership or Co-option?Partnership or Co-option?

Dr. Jan Wallcraft Operational Manager of SURGE (Service User Research Group for England)

What is service user What is service user involvement in research?involvement in research?

• Seeking out, listening to and acting Seeking out, listening to and acting on the views and experiences of on the views and experiences of service users service users

• and/or working together with service and/or working together with service users at all stages of the research users at all stages of the research process.process.

• (NOT to be confused with RECRUITMENT of (NOT to be confused with RECRUITMENT of research participants/ subjects)research participants/ subjects)

From Involving the Public, INVOLVE 2004

MHRN and SURGEMHRN and SURGE

Surge’s role is to ensure service user Surge’s role is to ensure service user involvement throughout MHRN and involvement throughout MHRN and the projects it adoptsthe projects it adopts

We want to ensure that this is REAL We want to ensure that this is REAL involvement, not tokenisticinvolvement, not tokenistic

It will take time to build service user It will take time to build service user capacity and to create learning capacity and to create learning opportunities for clinical researchersopportunities for clinical researchers

Research participation: why do it?Research participation: why do it? Service users can provide a valuable Service users can provide a valuable

perspective shaped by knowledge of perspective shaped by knowledge of people’s experiences of health issues and people’s experiences of health issues and health care that researchers may not have health care that researchers may not have or may have forgottenor may have forgotten

Service users can provide a fresh, Service users can provide a fresh, interested “outsiders” look at the work and interested “outsiders” look at the work and may bring new thoughts and ideas to the may bring new thoughts and ideas to the research processresearch process

Service users can help ensure the wording Service users can help ensure the wording of documents such as consent forms, of documents such as consent forms, information sheets and reports is information sheets and reports is understandable to service users, carers understandable to service users, carers and members of the public and members of the public

(from: (from: National Programme on Forensic Mental Health R&D – User National Programme on Forensic Mental Health R&D – User involvement induction pack)involvement induction pack)

What is service user What is service user participation in research?participation in research?

Many levels - Many Roles Many levels - Many Roles

Consultation <-> Collaboration <-> Consultation <-> Collaboration <-> Control Control

‘‘We involve service users in trials’We involve service users in trials’what counts as participation? what counts as participation?

Giving patients in Giving patients in clinical trials more clinical trials more information?information?

Asking local service Asking local service users to help recruit to users to help recruit to trials?trials?

Offering service users Offering service users work as researchers?work as researchers?

Consultation on some Consultation on some aspects of the aspects of the research – e.g. research – e.g. methods or methods or recruitmentrecruitment

Bringing service user Bringing service user groups into early groups into early planning of a research planning of a research proposal?proposal?

Inviting service users Inviting service users to help think about to help think about what should be what should be researched?researched?

Giving service users Giving service users resources and support resources and support to run a research to run a research project ?project ?

Good practice in participation – the Good practice in participation – the stagesstages

From ‘Involving the Public’, INVOLVE 2004

SURGE Guidance for Good SURGE Guidance for Good Practice key points:Practice key points:

• Be flexible and prepared to negotiateBe flexible and prepared to negotiate about about the research process the research process

• Deal with differences of opinionDeal with differences of opinion with with sensitivity and respect sensitivity and respect

• Maintain working relationshipsMaintain working relationships throughout throughout and after the end of the project to:-and after the end of the project to:-

• Build for future workBuild for future work. Involve service users in . Involve service users in dissemination dissemination Celebrate new learningCelebrate new learning

Download full report from: www.mhrn.info/surge.html/

Good Practice GuidanceGood Practice Guidance Step by step – Undertaking Step by step – Undertaking

ResearchResearch• Support, supervision and trainingSupport, supervision and training for everyone for everyone

involved is most important involved is most important – ( see resource checklist in guidance)( see resource checklist in guidance)

• Consider Consider payment, time & personnelpayment, time & personnel

• Practical, emotional & research supportPractical, emotional & research support

• Training for researchers and service usersTraining for researchers and service users

Clinical trials in mental healthClinical trials in mental health4 types or phases4 types or phases

Phase 1 – basic Phase 1 – basic research - 1research - 1stst step step trials of new drugs or trials of new drugs or treatmentstreatments usually small – up to 30 usually small – up to 30

patients.patients.

Phase 2 – basic Phase 2 – basic research 2research 2ndnd step: step: Does the new Does the new treatment work well treatment work well enough for full scale enough for full scale comparison with comparison with existing treatments? existing treatments? Up to 50 patients. Up to 50 patients.

Looking for what type of Looking for what type of problems it helps and problems it helps and for side effects and for side effects and correct dosagescorrect dosages

Phase 3 – comparison Phase 3 – comparison of new treatment with of new treatment with standard treatmentsstandard treatments may be 1000s of may be 1000s of

patients in trialpatients in trial usually randomised usually randomised

controlled trialscontrolled trials Phase 4 – trials done Phase 4 – trials done

on drugs already on drugs already shown to workshown to work to find out more about to find out more about

safety and long-term safety and long-term risksrisks

how does the treatment how does the treatment work in wider more work in wider more general use – outside general use – outside clinical trialsclinical trials

MHRN and the pharma industryMHRN and the pharma industry

Mental Health Research Network has been Mental Health Research Network has been told it must work with the pharma industry told it must work with the pharma industry and take on trials of drugs – probably and take on trials of drugs – probably phase 3 & 4 type large-scale trials – (not phase 3 & 4 type large-scale trials – (not basic research step 1&2)basic research step 1&2)

Key issues for the pharma industry are Key issues for the pharma industry are speed of access to patients and reduction speed of access to patients and reduction of ‘red tape’of ‘red tape’

MHRN is seeking ways to work with MHRN is seeking ways to work with pharma companies without compromising pharma companies without compromising its standards of research governanceits standards of research governance

Service users’ views on working Service users’ views on working with pharma companieswith pharma companies

On Our Own Terms On Our Own Terms research showed that more research showed that more than a third of service than a third of service users would consider drug users would consider drug company funding if the company funding if the circumstances are right, circumstances are right, e.g:e.g: If the drug company puts If the drug company puts

all its cards on the table all its cards on the table and the deal is acceptableand the deal is acceptable

If the group is desperate If the group is desperate for funding for a good for funding for a good purpose and there is no purpose and there is no other alternativeother alternative

If the drug company is If the drug company is committed to ethical committed to ethical research principlesresearch principles

However, a larger However, a larger proportion, nearly half, proportion, nearly half, were opposed to funding were opposed to funding from pharma companiesfrom pharma companies ‘‘drug companies are not drug companies are not

going to want to talk about going to want to talk about alternative therapies, are alternative therapies, are they?’they?’

‘‘it doesn’t seem right to it doesn’t seem right to me, but it’s a personal me, but it’s a personal decision’decision’

‘‘to accept money would be to accept money would be to give legitimacy to the to give legitimacy to the drug companies’ views on drug companies’ views on chemical imbalances, so I chemical imbalances, so I wouldn’t find it wouldn’t find it acceptable’acceptable’

On Our Own Terms: download from www.scmh.org.uk publications

Can participation work?Can participation work?

From Involve 2004From Involving the Public, INVOLVE 2004

Can the relationship with the Can the relationship with the Pharma industry work?Pharma industry work?

Preconditions:Preconditions: Industry studies to be Industry studies to be

judged on same criteria judged on same criteria as other studies as other studies (though procedures (though procedures may be speeded up)may be speeded up)

Service user Service user involvement on involvement on Adoptions Committee Adoptions Committee for pharma studiesfor pharma studies

MHRN will discuss with MHRN will discuss with Medicines Regulatory Medicines Regulatory Authority the rules for Authority the rules for service user service user involvement with involvement with pharma industry pharma industry

SURGE toSURGE to ask service users for ask service users for

suggestions to improve suggestions to improve clinical trial procedures clinical trial procedures – e.g. how to make – e.g. how to make involvement effective involvement effective and trials more service-and trials more service-user friendlyuser friendly

MHRN to MHRN to look at ways to bring in look at ways to bring in

service user values into service user values into outcome measures for outcome measures for clinical studiesclinical studies

Hopes for the future of participation Hopes for the future of participation in research: an optimistic scenario:in research: an optimistic scenario:

Service user Service user participation will lead to participation will lead to all clinical trials all clinical trials (including pharma (including pharma industry) being industry) being submitted for approval submitted for approval to committees of well-to committees of well-trained, experienced trained, experienced service users at the service users at the concept stageconcept stage

New research methods New research methods and measures will be and measures will be developed with service developed with service user participationuser participation

No clinical trial will be No clinical trial will be acceptable unless its acceptable unless its methods and outcome methods and outcome measures reflect measures reflect service user values e.g.service user values e.g.

low risk to low risk to participants,participants,

good informationgood information choice, self-choice, self-

management, and management, and recovery goals recovery goals

Money and support will Money and support will be made available for be made available for large-scale service-user large-scale service-user led researchled research

The Answer!The Answer!

Involve Newsletter Autumn 2005