epis meeting - dr derick mitchell - october 2017
TRANSCRIPT
October 17th, 2017
PATIENTS – SCIENCE – INDUSTRY
Sustaining patient engagement resources - public-private platforms
Derick Mitchell
My Talk
1. IPPOSI?
2. Patient Involvement in Medicines R&D
3. How patient orgs & industry can interact
4. Generating patient-based evidence
Collaborative sensemaking
“We are witnessing the collapse of expertise and the
rise of collaborative sensemaking”
David Holzmer
IPPOSI? Who?IPPOSI
A patient-led organisation that works with patients, government, industry,
& science to put patients at the heart of health innovation
IPPOSI Priorities
20
Actively advocate for improved + equitable
patient access to Health Innovation
Promote meaningful patient involvement in
Health Research and Policy
Patient-led activities
Health Hacks
Workshops
Conferences
Consultations
Round-tables
Working Groups
Training Days
Rare Diseases
eHealth
Clinical Research
Health Information
Health Economics
Patient Registries
Biobanking
Incorporating the patient voice
• Hierarchical Rhetoric
• ‘Walking the walk’ at the highest possible level
Challenges:• Decision-makers never want to change their processes
• Patients are not trained in health policy, dialogue
• Many patient orgs are not focused on policy/R&D issues
“The perfect is the enemy of the good”
What do patient advocates want re: medicines R&D?
That the patient voice is listened to
• To be involved as early as possible in clinical research design, priority setting, policy
• To improve the quality of clinical research - less wastage
• To ensure better use/reuse of research outputs and tools
• To generate impact and burden data to support the results of the clinical trials
• To use online / ehealth / mobile health apps to generate patient-based evidence
Practical “Roadmap” on patient involvement in medicines R&D
Research design
and Planning
Design of Protocol
Informed Consent Study reporting
Post-study communication
Patient Info
Leaflet
Trial steering committee
Investigators Meeting
Level of expertise in the disease area required:
mediumhigh
Data Monitoring Committee Practical
considerations
Health Technology Assessment
Protocol
Synopsis
Research
priorities
Setting
research
priorities:
Information to
trial participants
Research conduct and
operations
Regulatory affairs
Dissemination,
communication,
post-approval
Source: Geissler, Ryll, Leto, Uhlenhopp (2017)Therapeutic Innovation & Regulatory Science. (doi: 10.1177/2168479017706405)
Fundraisingfor research
Ethics Review
Where do we want to get to?
http://www.ema.europa.eu/ema/index.jsp?curl=pages/partners_and_networks/general/general_content_001738.jsp&mid=WC0b01ac0580b15dc7
How patients, industry can interact on R&D
• Move from obsessive use of compliance to measuring the value of interaction
• Look at legislation, regulation, codes of conduct and see what needs to be changed
• Avoid rhetoric of ‘patient voice’ – not matched by reality
Challenges to interacting
• Lack of Trust
• Lack of mutual learning
• Perceived (or real) legal barriers, conflict of interest
• Silo-thinking, finger-pointing
• Lack of standardized metrics to measure impact and benefits of patient
involvement
• Lack of capacity and training in patient organisations
• Over-compliance
Basic Rules
• Trust and transparency
• All that patient organisations have is their credibility
• They must also be effective and feel trusted
Transparency and Independence
• Basic principles, values = existing codes are good
• Achieve financial transparency
• Maintain independence
• Rules for reputation and credibility
Guidance on industry interaction
• Identify roles and opportunities for patients to interact in a systematic way
• Guidance on:
• Defining the patient
• Defining the interaction
• Ways for Identifying patients
• Writing collaboration agreements
• Rules of compensation
• Transparency & Disclosure
• Events & Hospitality
• Appendices: Roadmap for PPI; Codes; Confidentiality agreement, Written agreement
A framework of patient engagement
Engages
Empowers
Educates
Evaluates
Evolves
A framework that enables structured, effective, meaningful, ethical, innovative, and sustainablepatient engagement
(and demonstrates the ‘return’ on this engagement for all actors)
IPPOSI & The European Patients Academy
• EUPATI produces Expert Patients on Medicines Research & Development
• Provides Training & Education
• Disseminates through national platforms
The project received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115334, resources of which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies.
www.eupati.eu
18+ EUPATI National Platforms
• Bring all stakeholders together in countries
• Address educational needs in R&D
• Disseminate EUPATI’s training material
National platforms now established in:
AT, BE, FR, DE, IE, IT, LU, MT, PL, ES, CH, UK, DK, SK, PT, NO, RO, GR
Additional platform initiatives ongoing in Serbia, Brazil, Japan
Roles change as a result of EUPATI course- creating patient leadersRole 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.
First Irish Patient Education Programme
7-month-pilot programme in Health Innovation
3 Modules – Clinical Trials, Regulatory Affairs, HTA Practices
3 Education Partners - UCD, TCD, HPRA
1 elearning website: www.patientsinvolved.ie
21 Students from 9 counties - 36 applications
Building a new Irish health research environment
Patient & Public Involvement (PPI)
2014 – PPI Paper - Irish Health Research Forum
2016/17 – PPI Reviewers – Health Research Board
2017 – PPI Funding – €1.2mio - HRB + IRC
2017 – Scientific Advice – Patient Involvement – HPRA
Building a new Irish healthcare environment
2008 - National Strategy for Service User Involvement in Health and Social Services (DoHC & HSE)
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2016 – Values in Action, QID Cultures of Person-centeredness (HSE)
2016 – Mental Health Local Recovery Groups (HSE)
2016 – Privacy Impact Assessment for Individual Health Identifier (eHealth Ireland)
2017 - National Patient Experience Survey - Hospitals (HIQA, HSE, DoH)
2017 - National Clinical Effectiveness Committee – PPI Values (DoH, NCEC)
2017 –Personas for Electronic Health Records (eHealth Ireland)
2017/18 - Patient Narrative Project on Person-centered care (CSPD-HSE, IPPOSI)
EU Clinical Trial Regulation, 2018
Building a new European environment
General Data Protection
Regulation, 2018
Generating patient-based evidence
• Stakeholders take decisions based on evidence, not on (our) anecdotes
• Patient organisations are best-placed to generate patient-relevant data
• Cost-effectiveness is key. Prove that the informed patient is cost-effective…..!
Patient Registries
• Evaluating new treatments in real-world settings (Pharmaco-vigilance)
• Rare Disease Reference Centres of Excellence
Slide courtesy of Abigeal Jackson, CF Registry of Ireland
Umotif, PatientslikeMe, Carenity
Graphically display charts, timelines and various representations of different measures
Person centered co-ordinated care
Phase 1
What people in Ireland want to experienceduring their care when they require anumber of health services at one time orover time
Phase 2 + 3
A framework that will hear peoples’ experiences of using more than one health service at a time
11 Focus
Groups
2 Online
Surveys
4 Regional
Workshops
Output: Statements (19) + Definition (1)
Online Survey
+ System
Partnerships
By end of 2017… By end of 2018…
A ‘tried and tested’ framework
• To hear a high volume of patients’ experiences through the online survey
• To use data to influence service design, delivery and improvement of integrated care
• A qualitative and quantitative evaluation of the proof of concept within the context of the HSE;
Integration into ‘business as usual’
• Framework (incl. resource implications) to be integrated into a ‘business as usual’ model
• Quality and Patient Safety Structures at CHO level will be essential
• QID publication: ‘Quality and Safety Committees; Guidance and resources’
Take home messages
• 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
• Over-interpretation and legal paternalism is a barrier to trusted, effective partnership
• Healthcare Environment is changing….are you?
With thanks to…
• Abigeal Jackson, CF Registry of Ireland
• Jan Geissler, Patvocates
• Avril Daly, Retina International
• David Haerry, EATG
• Francois Houyez, EURORDIS
• Matthew May, EUPATI
• Kaisa Immonen, EPF
• Aine Carroll, HSE