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2020
The European Patients’ AcademyEUPATI
What this presentation covers:
Why EUPATI?
Health research & policy is changingat a fast pace
Innovation transforms the lives of patients with serious, life-long conditions:
Molecular targets/pathways Genome sequencing, Translational research Personalized medicine
• Small trial populations • Biomarkers, companion diagnostics
Need for post-marketing data Health Technology Assessment,
QoL, endpoints, comparators BUT long term pressure on health budgets
– here to stay
Window ofopportunity trial design relationship
between researchers, regulators, industry, patients
4
Public
Research Ethics Committees
Competent authorities
Policy makers/Research Policy
HTA agencies& committees
Research subject
Info provider
Advisor
Reviewer
Co-researcher
Driving force
Clinical Research
Patients have a key role in all aspects ofhealth-related research
Trial protocol design, informed consent, ethical
review, marketing authorization, value
assessment, health policy
Patient involvement in practicewithin the R&D life cycleSource: Geissler, Ryll, Leto, Uhlenhopp – www.eupati.eu
Source: Geissler, Ryll, Uhlenhopp, Leto (2016): www.eupati.eu
Public
Research Ethics Committees
Competent authorities
Policy makers/Research Policy
HTA agencies& committees
Research subject
Info provider
Advisor
Reviewer
Co-researcher
Driving force
Clinical Research
Patients have a key role in all aspects ofhealth-related research
Trial protocol design, informed consent, ethical
review, marketing authorization, value
assessment, health policy
What is EUPATI?
European Patients’ Academy:Paradigm shift in empowering patients on medicines R&D Launched February 2012 as a public private
partnership, 33 consortium members,Funded by Innovative Medicines Initiative
Has developed and disseminatedobjective, credible, correct and up-to-date public knowledge about medicines R&D
Is building competencies & expert capacity among patients and the public
Has been a game changer and driver of patient engagement in R&D
Continues as a permanent educational program led by the EPF (since March 2017)
EUPATI Patient ExpertsTraining Course-- for expert patients
EUPATI develops education targeted at different levels
EUPATI Educational Toolbox-- for patient advocates
EUPATI Internet Library-- for the health-interested public
English FrenchGermanSpanishPolishItalian RussianDutchDanish(Portuguese)(Romanian)
English
1.Discovery of Medicines
2.Pre-clinical Development
3.Clinical Development
4.Clinical Trials 5.Regulatory
Affairs, Drug Safety, Pharmaco-vigilance
6.Health Technology Assessment
Reflecting European diversity: 9 languages
9 languages:• English • French• German• Spanish• Polish• Italian • Russian• Dutch• Danish
Many European countries:
UK, Ireland, Malta, France, Luxemburg, the francophone Belgium, Germany, Austria, Switzerland, Spain, Italy and Poland, plus Russian-speaking population in Central and Eastern Europe
Plus additional countries and languages in preparation by the community, e.g. Portuguese,Romanian etc.
Unique and unprecedented partnership between patient organisations, other public partners and pharmaceutical industry based on the philosophy of the IMI
• Unique in IMI that EUPATI is patient- and not industry-led
• Opportunity to establish an effective, transparent and credible partnership
• Exceptional learning experience for industry representatives to work with patient organisations in a constructive and reflective manner, which could serve as a role model in other environments as well
• Making best use of industry expertise in medicines R&D,incl. e.g. the legislative environment and development of ITP as required by law
Opportunity to strengthen the voice of the patients in the search for innovation and new medicines
Chance to reduce fear, lack of trust and misconception among patients regarding the pharmaceutical industry
Uniqueness of the partnership
What we bring in and what we produce will be owned by the public
All EUPATI material has been provided under the"Creative Commons License"• Content can be copied, distributed, edited, remixed, and
built upon, all within the boundaries of copyright law on non-commercial basis
• Authorship and licensing needs to stay intact and mentioned on all derivatives
• Similarly applied by e.g. Wikipedia, Google, and many others
See http://creativecommons.org/licenses/by/3.0/
Public license model guaranteesownership and re-use by the public
What has EUPATI delivered?
Facts and numbers (May 2020)
13,545
3,700,000
250,958
232
152
432,089 (613)
13 8
– users on busiest day in April 2020
– total users since launch
– European users of most used language
EUPATI trainees graduated from Cohorts 1, 2, 3 –
–words in the Toolbox (number of content pieces)
- 6 ENP run webinars- 7 general webinars
– new sessions developed for Cohort 3 Event 1
– countries use the Toolbox
EUPATI‘s work was based on solid research on patient & public attitudes towards medicines R&D
Review of existing information resources;230 resources reviewed.
Review of research literature; 12600 titlesand abstracts; 134 studies included
Public survey; 6931 responses in GB, Spain, Poland, Italy, France and Germany
Qualitative research with patients and thepublic; n=125 people
Qualitative research with stakeholders; n=56 (incl. policy makers, pharmaceuticalindustry, clinical research professionals)
Patient advocate survey; 468 responsesfrom across Europe
Patient advocate survey focused on course delivery; 41 responses
Results published in BMJ Open:
The EUPATI Patient Expert Training Course
EUPATI Patient Expert Training Courses
+Online self-learning
250 hours of e-learning and 8 days for two Face-to-Face meetings
over a period of 14 months
2 Face-to-face trainingweeks
EUPATI Patient Expert Training Courses
14-month in-depth training course of patient advocates on medicines R&D
152 graduates from 37 countries and 80+ disease areas completed Course 1, 2 & 3
Involvement of EUPATI Fellows and trainees evidenced in R&D projects, regulators, ethics
EUPATI Patient Expert Training Course: Rollout of course modules
EUPATI Courses 1, 2 & 3 Trainees by Disease Areas (74)2Achondroplasia1Adrenoleukodystrophy1Allergy and airways diseases3Arthritis
1Asperger´s syndrome/Fibromyalge and Chronic Fatigue Syndrome
1Asthma1Attention Deficit Hyperactivity Disorder1Autoimmune disease1Autoinflammatory diseases1Brain tumours5Breast cancer7Cancer2Cardiovascular Diseases1Chronic Fatigue2Chronic myelogenous leukemia1Chronic Pain1Coeliacy1Congenital Disorder of Glycosylation3Cystic Fibrosis3Diabetes1Disability1Ehlers-Danlos Syndrome1Endocrine tumours2Endometriosis1Epidermolysis bullosa (EB)1Fibromyalgia2Gaucher Disease4General advocacy1Genetic Disorders3Haemophilia
10Hematological Cancer1Hereditary haemorrhagic telangiectasia (HHT)5HIV1Incontinent patients1Leber’s Hereditary Optic Neuropathy3Leukemian (incl Chronic myelogenous leukemia)1Lipoprotein Lipase Deficiency
2Lung conditions4Lupus1McCune Albright syndrome5Melanoma1Mental Health5Multiple Sclerosis2Muscular atrophy6Muscular Dystrophy1Myeloma1Neurological Diseases1Neurofybromatosis1Oral Cancer2Paediatric Diseases2Paediatric Cancer2Parkinson's Disease2Pituitary disorders1Preterm Birth1Primary Immunodeficiences3Liver diseases (incl Primary Sclerosing Cholangitis)1Prostate Cancer1Pulmonary Hypertension
10Rare Diseases1Rare diseases/Friedrich’s Ataxia
1Rare diseases/Paroxysmal nocturnal hemoglobinuria
1Rare diseases1Rare diseases/Tuberous Sclerosis1Respiratory diseases1Rett Syndrome8Rheumatic diseases1Sanfilippo Syndrome2Sight loss1Spinal Cord Injury2Spinal Muscular Atrophy2Thalassaemia1Thalidomide victims1Tourette syndrome1Vasculitis
EUPATI courses 1, 2 & 3 trainees:36 countries
1Albania3Austria9Belgium1Croatina2Cyprus4Denmark2Finland5France1Georgia6Germany9Greece4Hungary
11Ireland1Israel7Italy1Kyrgyzstan1Latvia2Lithuania
1Luxembourg2Macedonia3Malta8Netherlands3Norway3Poland8Portugal6Romania3Russian Federation2Serbia2Slovakia1Slovenia
10Spain1Sweden9Switzerland1Turkey1Ukraine
21United Kingdom
Specific activities and roles developed by Fellows of the Course
“I am more respected as a EUPATI fellow…”
Advisoryrole
Promoted in roles
Involved in training
Involved in policy/
advocacy
Speaking jobs
Involved in R+D
Knowledge multiplier
Better negotiator
Formalised roles
Empowerment = respect = meaningful involvement = pride
Roles change as a result of the 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.
What our EUPATI trainees say about the EUPATI Patient Expert Training Course…
25
Šarūnas Narbutas from Lithuania (Lithuanian Cancer Patient Coalition, POLA):“10 days of superbly engaging discussions with 50 capable patient advocates is the capacity building experience equal to none”.
Begonya Nafría from Spain(Hospital Sant Joan de Déu, Barcelona):“It´s essential that patients and their families are involved in research on rare diseases. They have an immense expertise, and their needs must be taken into account”.
What our EUPATI trainees say about the EUPATI Patient Expert Training Course…
26
Birgit Bauer from Germany(MS patient and blogger about Multiple Sclerosis):“(…) I use my gained knowledge for articles, blogposts and for talks. I now have better arguments in discussion panels and understand the different perspectives of different stakeholders.”
Maria Piggin from England(PNH Support):“I have been provided with tools which give me confidence to assert the patients' voice. Each process examined highlights how a patient advocate can add value.”
What our EUPATI trainees say about the EUPATI Patient Expert Training Course…
27
Margaret Graham McDonald from Scotland(Healthcare Improvement Scotland):“The EUPATI course has harnessed the skills I needed to play an effective and active part in Research & Development with confidence.”
Stefano Mazzariol from Italy(Parent Project Onlus):“I would like to work with stakeholders to bring patients closer to research. I wish that all patients could benefit from the knowledge that I am acquiring in this course.”
The EUPATINational Platforms
21 EUPATI National Platforms (as of May 2020)
EUPATI National Platforms...
bring all stakeholders together in countries address educational needs in R&D disseminate EUPATI’s training material to patient
organisations
Evolution of ENP Network21 Established ENPs
What are ENPs doing?
ENP social media campaigns
ENP learning webinars
ENP workshops & conferences
ENP MoUs with partnersENPs on the TV
ENPs in the papers
The EUPATI Toolbox on Medicines R&D
EUPATI Toolbox on Medicines R&D in 9+ languages: Huge demand
• In English, French, Italian, Spanish, German, Polish, Russian, Dutch, Danish
• >2,000,000 unique users in 1 year
• App. 3,700 000 users since launch
• Visitors from 232 countries
EUPATI Toolbox on Medicines R&D:>3.500 content items
Infographics
ArticlesPowerPoints
Fact sheets
Access via different devices
Sessionsby country
Device % of usersDesktop 70%Mobile 27%Tablet 3%
Top articles viewed on website
0 100 200 300 400 500 600 700
/hta-systems-in-europe//making-medicine-step-1-pre-discovery/
/biomarkers//marketing-authorisation/
/key-principles-pharmacology//efficacy-safety-medicines/
/clinical-trial-designs//best-practices-for-patient-involvement-…
/phases-clinical-development//an-introduction-to-clinical-research/Top articles (EN)
Site categories in order of popularity (EN)
0 200 400 600 800 1000 1200
PharmacoepidemiologyNon Clinical Studies
Benefit and Risk AssessmentSafety of Medicines
Personalised MedicineRegulatory AffairsTypes of Medicine
Pharmaceutical DevelopmentHealth Technology Assessment
Drug DiscoveryClinical Development and Trials
Basics of Medicines Development
The EUPATI Mini-CourseStarter Kits
EUPATI Mini-Course Starter Kitsto run training days and courses
Core set of PPT slides in specific area of patient involvement,plus links to EUPATI Toolbox, Case Studies + Trainers Manual!
Patient involvement in…
Research designand Planning
ResearchPriorities
Research conduct andoperations
Dissemination Communication Post-approval
Setting researchpriorities
Protocol synopsis
Protocol design
Trial Steering Committee
Information to participants
Data MonitoringCommittee
Investigator meetings
Regulatory Affairs
Fundraising for research
Practical Considerations
Patient Information
Informed Consent
Ethics Review
Study Reporting
HealthTechnology Assessment
Post-Study Communication
EUPATI Mini-Course Starter Kitsto run training days
The EUPATI Guidanceson the interaction of patients with regulators, HTA bodies,
industry and ethics committees
EUPATI Guidances for patient involvement and interaction – Why? Patients & patient organisations to be involved more widely
• include early & post-approval stages, not confined to clinical development
Overarching guidance on meaningful and ethical interaction is missing in many areas, especially in R&D, causing insecurity• Existing codes/regulations hold mostly legal & ethical
content, i.e. collaboration, communication, funding -- do not cover patient involvement in R&D
• e.g. EFPIA, EATG code, PCWP framework, ECAB, EMA framework, HTAi
Language needs to be more directive towards patient involvement • Clear default statement that collaboration is allowed unless
expressly forbidden
EUPATI Guidances to support the interaction with patient organisations in R&D
EUPATI has developed guidance documents for the interaction of patient organisations with stakeholders in industry-led R&D in HTA bodies in regulatory processes in ethics committees
Available for download at EUPATI.eu > Resources > Guidances
The EUPATI webinar library
EUPATI branded and co-branded webinars EUPATI has been producing a series of webinars on key
aspects of the medicine R&D and clinical development process Most webinars produced by EUPATI team and alumni Co-production with and technical support to patient groups for
their webinars All content free and publicly accessible with slide decks
attached
https://www.eupati.eu/category/webinar/
The EUPATI Production and Quality Assurance Process
Solid EUPATI production & review process to guarantee objectivity
In consultation of the external advisory boards, EUPATI has implemented a solid multi-stage multi-stakeholder production and review process
Internal production and review process• Content created by experts from different stakeholders • EUPATI Editorial Group (comprising patient organisations, academia,
Industry, NGOs) collectively reviewed each topic to ensure content is consistent, avoids unnecessary duplication and is fit for intended audience/purpose.
External testing and review process• User-tested with target audience• Reviewed by independent Project Advisory Board members (e.g.
journalists, academics, ethics committee members)• Relevant topics reviewed by independent regulatory experts and HTA
experts• edited for appropriate language by health literacy experts
Solid EUPATI production & review process to guarantee objectivity
What will EUPATIdo next?
Please be in touch!info@eupati.eu
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