1. Service user participation in clinical trials Partnership or Co-option? Dr. Jan Wallcraft Operational Manager of SURGE (Service User Research Group for England)

2. What is service user involvement in research? Seeking out, listening to and acting on the views and experiences of service usersSeeking 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.and/or working together with service users at all stages of the research process. (NOT to be confused with RECRUITMENT of research participants/ subjects)(NOT to be confused with RECRUITMENT of research participants/ subjects)

3. From Involving the Public, INVOLVE 2004

4. MHRN and SURGE Surges role is to ensure service user involvement throughout MHRN and the projects it adopts Surges 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 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 It will take time to build service user capacity and to create learning opportunities for clinical researchers

5. Research participation: why do it? Service users can provide a valuable perspective shaped by knowledge of peoples experiences of health issues and health care that researchers may not have or may have forgotten Service users can provide a valuable perspective shaped by knowledge of peoples 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)

6. What is service user participation in research? Many levels - Many Roles Consultation Collaboration Control

7. We involve service users in trials what counts as participation? Giving patients in clinical trials more information? Giving patients in clinical trials more information? Asking local service users to help recruit to trials? Asking local service users to help recruit to trials? Offering service users work as researchers? Offering service users work as researchers? Consultation on some aspects of the research – e.g. methods or recruitment Consultation on some aspects of the research – e.g. methods or recruitment Bringing service user groups into early planning of a research proposal? Bringing service user groups into early planning of a research proposal? Inviting service users to help think about what should be researched? Inviting service users to help think about what should be researched? Giving service users resources and support to run a research project ? Giving service users resources and support to run a research project ?

8. Good practice in participation – the stages From Involving the Public, INVOLVE 2004

9. SURGE Guidance for Good Practice key points: Be flexible and prepared to negotiate about the research processBe flexible and prepared to negotiate about the research process Deal with differences of opinion with sensitivity and respectDeal with differences of opinion with sensitivity and respect Maintain working relationships throughout and after the end of the project to:-Maintain working relationships throughout and after the end of the project to:- Build for future work. Involve service users in dissemination Celebrate new learningBuild for future work. Involve service users in dissemination Celebrate new learning Download full report from: www.mhrn.info/surge.html/

10. Good Practice Guidance Step by step – Undertaking Research Support, supervision and training for everyone involved is most importantSupport, supervision and training for everyone involved is most important –( see resource checklist in guidance) Consider payment, time & personnelConsider payment, time & personnel Practical, emotional & research supportPractical, emotional & research support Training for researchers and service usersTraining for researchers and service users

11. Clinical trials in mental health 4 types or phases Phase 1 – basic research - 1 st step trials of new drugs or treatments Phase 1 – basic research - 1 st step trials of new drugs or treatments usually small – up to 30 patients. usually small – up to 30 patients. Phase 2 – basic research 2 nd step: Does the new treatment work well enough for full scale comparison with existing treatments? Phase 2 – basic research 2 nd step: Does the new treatment work well enough for full scale comparison with existing treatments? Up to 50 patients. Looking for what type of problems it helps and for side effects and correct dosages 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 Phase 3 – comparison of new treatment with standard treatments may be 1000s of patients in trial may be 1000s of patients in trial usually randomised controlled trials usually randomised controlled trials Phase 4 – trials done on drugs already shown to work Phase 4 – trials done on drugs already shown to work to find out more about safety and long-term risks to find out more about safety and long-term risks how does the treatment work in wider more general use – outside clinical trials how does the treatment work in wider more general use – outside clinical trials

12. MHRN and the pharma industry 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) 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 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 MHRN is seeking ways to work with pharma companies without compromising its standards of research governance

13. Service users views on working with pharma companies 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: 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: If the drug company puts all its cards on the table and the deal is acceptable 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 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 If the drug company is committed to ethical research principles However, a larger proportion, nearly half, were opposed to funding from pharma companies However, a larger proportion, nearly half, were opposed to funding from pharma companies drug companies are not going to want to talk about alternative therapies, are they? drug companies are not going to want to talk about alternative therapies, are they? it doesnt seem right to me, but its a personal decision it doesnt seem right to me, but its a personal decision to accept money would be to give legitimacy to the drug companies views on chemical imbalances, so I wouldnt find it acceptable to accept money would be to give legitimacy to the drug companies views on chemical imbalances, so I wouldnt find it acceptable On Our Own Terms: download from www.scmh.org.uk publicationswww.scmh.org.uk

14. Can participation work? From Involve 2004 From Involving the Public, INVOLVE 2004

15. Can the relationship with the Pharma industry work? Preconditions: Preconditions: Industry studies to be judged on same criteria as other studies (though procedures may be speeded up) 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 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 MHRN will discuss with Medicines Regulatory Authority the rules for service user involvement with pharma industry SURGE to SURGE to ask service users for suggestions to improve clinical trial procedures – e.g. how to make involvement effective and trials more service-user friendly 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 MHRN to look at ways to bring in service user values into outcome measures for clinical studies look at ways to bring in service user values into outcome measures for clinical studies

16. Hopes for the future of participation in research: an optimistic scenario: 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 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 New research methods and measures will be developed with service user participation No clinical trial will be acceptable unless its methods and outcome measures reflect service user values e.g. No clinical trial will be acceptable unless its methods and outcome measures reflect service user values e.g. low risk to participants, low risk to participants, good information good information choice, self- management, and recovery goals choice, self- management, and recovery goals Money and support will be made available for large- scale service-user led research Money and support will be made available for large- scale service-user led research

17. The Answer! Involve Newsletter Autumn 2005