Clinical Trials Event , Mansion House, Dublin, 10052018
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A presentation delivered by Derick Mitchell, IPPOSI CEO at the event to celebrate International Clinical Trials Day on May 10th, 2018 in the Mansion House, Dublin, organised by HRB-CRCI.
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Clinical Trials Event , Mansion House, Dublin, 10052018
- 1. IPPOSI? Who?IPPOSI A patient-led organisation that works with patients, government, industry, & science to put patients at the heart of health innovation
- 2. The Impact of Patient Education Role Before EUPATI After Member of patient organisation, not actively involved 17% 2% Active role in a patient organisation 62% 71% Leadership role in a patient organisation 62% 71% Employee of a patient organisation 25% 23% Volunteer role in a patient organisation 60% 67% Presenting at conferences, workshops etc. 63% 83% Advising a pharmaceutical company 13% 44% Advising a regulatory agency 21% 42% Advising a reimbursement agency 4% 8% EUPATI Fellows are increasingly taking leadership roles and are engaging with pharma, regulators and HTA bodies. Role changes also imply identity shifts.
- 3. Patient & Public Involvement in 2018 Research Leadership 5 PPI Ignite awards (€1.75m) University of Limerick – Prof Anne MacFarlane University College Dublin - Prof Thilo Kroll NUI Galway - Prof Sean Dinneen Dublin City University - Dr Veronica Lambert Trinity College Dublin - Prof Mary McCarron Royal College of Surgeons, Ireland University College Cork Irish College of General Practitioners Clinical Research Centres / Facilities Many other Irish researchers and research orgs Health Agency Leadership Dept. of Health Muiris O’Connor, Head of Research & Analytics, Assistant National Director HSE Ana Terres – HSE Head of Research and Development, Assistant National Director HRB Anne Cody – Head of Pre-Award, Public Reviewers of proposals
- 4. 2018- Where are we? Patient / Patient Org. Leadership • Umbrella Groups: • IPPOSI - Derick Mitchell, CEO • MRCG - Avril Kennan, CEO • Condition-specific patient orgs: • Retina International – Avril Daly, CEO • Irish Cancer Society – Averil Power, CEO • MS Ireland – Ava Battles, CEO • CF Ireland – Philip Watt, CEO • Rare Disease Groups • 9 Irish EUPATI Fellows (+4 more) • Irish Health Research Forum Links to International Leadership • EUPATI • European Patients Forum • EURORDIS • Several UK groups (NIHR, INVOLVE, James Lind, COMET, CRUK, etc.) • PCORI (USA) • CIHR (Canada) • Cochrane • EU Projects - H2020, IMI
- 5. 2018- Where are we? Public / Patient / Media Interest
- 6. Wow!.....passionate and knowledgeable about PPI in research Early Adopters Constituency 2 Constituency 3 “Hmm . . . show me the evidence that all this works and is helpful” “Well …. PPI is a good idea but where on earth do I start?”
- 7. Current Challenges • Research not (yet) embedded in Irish healthcare system? • Support & Training for Patients for specific roles in research? • Equality, Inclusiveness & Sustainability of current efforts? • How to shift the power balance between researchers and patients? • Qualitative research tends to be at bottom of research hierarchy? • Evidence of the value and impact of PPI? • An over-arching vision for PPI in Research?
- 8. Metrics of Value of Involvement • Anecdotal ----Qualitative----Quantitative • Time / Cost savings • Improved relationships • Outcomes of relevance to patients
- 9. Assessing the Financial Value of PPI From: A Quantitative Approach from CTTI’s Patient Groups and Clinical Trials Project. Levitan B et al., Drug Inf J : Therapeutic Innovation & Regulatory Science. Published: July 17, 2017. https://doi.org/10.1177/2168479017716715
- 10. “A unique framework that enables structured, effective, meaningful, ethical, innovative, and sustainable patient engagement (PE) and demonstrates the ‘return on the engagement’ for all players.” Research priority setting Early dialogues with regulators and HTA bodies Design of clinical trials
- 11. Building Capacity of ‘Patient Leaders’ • Patient Ambassadors • to actively engage to represent a patient perspective in medicines development processes by interacting with scientific committees, HTA agencies, industry, regulatory bodies, academia and other relevant actors. • Patient Journalists • to contribute to raising awareness on patient involvement in medicines R&D amongst lay patients, hard-to-reach patients and the lay public. • Patient Facilitators/Trainers • to become engaged in training activities supporting the dissemination of the education and information programmes to patient communities, general public
- 12. Irish Patient Education Programme Module Educational Partner IPPOSI Pilot 1. Understanding Clinical Trials University College Dublin CRC 6 weeks blended learning 2. Regulatory Affairs, Medicines Safety, Pharmacovigilance Health Products Regulatory Authority 6 weeks blended learning 3. Health Technology Assessment Dept. of Pharm + Ther. TCD + NCPE + HIQA 7 weeks blended learning Blended Learning 150 hours e-learning in total: www.patientsinvolved.ie Each Module begins and finishes with half-day face-to-face workshop Online Mentoring, Quizzes, Weekly Tasks
- 13. Three Modules – different approaches MoU WITH UCD CLINICAL RESEARCH CENTRE • Created 40 purposely designed online lectures, • Significant support from CRC administration + School of Medicine IT dept. • Certificate of completion with UCD + IPPOSI logo IPPOSI COLLABORATION WITH HPRA • Engaged 10+ HPRA staff in pre-existing EUPATI content • Generated Irish-specific content. • Certificate of completion with HPRA + IPPOSI logo MoU WITH TCD DEPT. OF PHARM + HTA AGENCIES • Engaged senior TCD + NCPE + HIQA staff in pre- existing EUPATI content • Generated Irish-specific content • Certificate of completion with NCPE + IPPOSI + HIQA logo
- 14. Applications • Total Applications: 36 • Applications Rejected (i.e. after checking for completeness, mandatory letter of motivation, etc.): 7 • Valid Applications: 29
- 15. Patient Organisations applying • Alpha -1 Action Group • Arthritis Ireland • Irish Children's Arthritis Network • Irish Cancer Society • National Council for the Blind, Ireland • Fighting Blindness (4) • Vasculitis Ireland Awareness (3) • Migraine Association of Ireland • Spinal Injuries Ireland • Irish Neonatal Health Alliance • FibroIreland • Tick Talk Ireland • Cancer Trials Ireland PAAG • ISGO PPI (Gynae Oncology) • Patients for Patient Safety Ireland • EASO Patient Council (Obesity) • Sound Advice (Hearing) • Order of Malta • Chronic Pain Ireland
- 16. Group 1 Group 2 Group 3 Results of 6-member application review panel
- 17. Graduation
- 18. Student Feedback – most valuable aspect? The empowerment that the course provides cannot be underestimated. At the end of the course I felt that my knowledge of an area that I have worked in for many years has been enriched and I would gladly have accepted even greater detail in the course content. Being introduced to the world of patient advocacy in Ireland and EU and giving me a confidence that this is an area that I can be a part of and make changes. The commitment given by all those preparing the material for the course was much more than I could possibly expect. I felt very privileged at the attention to detail and the need to make sure we were getting the best from the course and understanding all the segments. HPRA input gives me the confidence to understand the way the system works in Ireland, I understand their website and feel confident that I can contribute information / use it in the future. The tutors that were made available. To have that quality of expertise available to us was exceptional.
- 19. Impact
- 20. Meaningful Opportunities RARE DISEASE TECHNOLOGY AND HIGHLY SPECIALISED THERAPIES REVIEW COMMITTEE PUBLIC REVIEWING OF PROPOSALS EARLY SCIENTIFIC ADVICE PILOT
- 21. MANY, MANY THANKS TO… • IPPOSI • IPPOSI Board members • IPPOSI Staff • Irish EUPATI Platform members • Patient, Carer Communities • IPPOSI patient members • EUPATI Network • EUPATI fellows • Universities: • UCD – Clinical Research Centre • TCD – Dept. of Pharmacology & Therapeutics • 6-member application review panel • PPI Ignite projects in TCD and UCD – public funding • State Agencies: • HPRA • NCPE • HIQA • HRB supportive • Industry: • 5 IPPOSI member companies • Abbvie • GSK • ICON • Janssen • Pfizer - private funding
Notas do Editor
- A patient-led platform that provides a structured way of facilitating interaction between patients, government, industry, science and academia to put patients at the heart of policy and medicines development. In pursuit of this we hold workshops, discussion groups, training days and conferences on policy, legislation and regulation around the development of new medicines, products, devices and diagnostics for unmet medical needs.
- The visible top represented the early adopters already passionate and knowledgeable about PPI in research. But under the water lurks a larger two part constituency. The “well PPI is a good idea but how on earth do you do it?” group, and the “Hmm . . . show me the evidence that all this works and is helpful” group. A warning was then issued that the network must avoid preaching to the converted and ensure it reaches out to the hearts and minds of those “below” the water line. “The Irish paradox.” Louise Locock, professor of health services research at the University of Aberdeen, pointed out that while Scotland is widely seen as a leader in patient centred care, it only funds one (part time) person to embed PPI in research. Victoria Thomas, head of public involvement at NICE, pointed to another conundrum: the persistent tendency to put qualitative research—which is relevant and important in relation to a lot of the work around PPI—down the bottom of the research hierarchy. One issue where all were in agreement was that there is a need to shift the power balance between researchers and patients, for it still remains firmly skewed towards the former.
- “the Scottish paradox.” Louise Locock, professor of health services research at the University of Aberdeen, pointed out that while Scotland is widely seen as a leader in patient centred care, it only funds one (part time) person to embed PPI in research. Victoria Thomas, head of public involvement at NICE, pointed to another conundrum: the persistent tendency to put qualitative research—which is relevant and important in relation to a lot of the work around PPI—down the bottom of the research hierarchy. One issue where all were in agreement was that there is a need to shift the power balance between researchers and patients, for it still remains firmly skewed towards the former.
- Convincing the health economists
- Focus: the three decision-making points
- Expectations from students beforehand: Information, Knowledge, Understanding Uncertainty What students got out of it: Confidence Credibility - Certificate of completion Connections Insights
- Students have asked IPPOSI to create a private facebook group so they can communicate with themselves
- When someone tells you that patients cannot understand or just do not want to know, just look at the data….. Our relationship is fragile, dynamic, uncomfortable, ambitious, and goal-oriented Healthcare Environment is changing….are you?