1. business and industrial
2. business operations
3. management
4. project management

Patients’ self-competence:
EUPATI provides the tools
April 2015
The project is receiving 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.
Outline

Why EUPATI?

What is EUPATI?
• Content
• Who is behind it?

EUPATI tools & course
Health research & policy is changing
at a fast pace
Innovation transforms the lives of
patients with serious, lifelong 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 of
opportunity
 trial design
 relationship
between
researchers,
regulators,
industry,
patients
3
Patients as partners: partnership model
requires a paradigm shift, and more
training for patients and advocates
Pre-clinical and
clinical
research
Driving force
Co-researcher
Competent Authorities
Policy
Makers/Research
Policy
HTA
Agencies/Committees
Research Ethics
Committees
Reviewer
Advisor
Info provider
Research subject
Source: PatientPartner
FP7 Project (2010)
4
EUPATI is needed because…

Patient advocates…
• Increasingly complex and professional task of advising on protocol
design, informed consent, ethical review, marketing authorisation,
value assessment, health policy
• Often self-taught and have gaps in the education and training
required to participate as an equal partner in medicines R&D
• Experience at EATG scientific working group, EMA Patient &
Consumer Working Party shows extensive training needs –
members currently need a lot of time & learning before getting to
full speed.

Prior to EUPATI the FP7-funded PatientPartner project demonstrated
a clear need & willingness of patient advocates to be an active
partner in medicines research and development
What is EUPATI?





A Public Private Partnership within the
Innovative Medicines Initiative Joint
Undertaking*
A 5-year project, launched in February 2012
A patient-led project coordinated by the
European Patients’ Forum, with EGAN,
EURORDIS and EATG in leadership roles
A strong multi-stakeholder consortium of
patients’ organisations, academia, NGOs and
industry – 30 organisations
The key pan-European initiative to build
competencies & expert capacity among
patients and the health-interested public
* Resources are composed of financial contribution from the European Union's Seventh Framework Programme and in-kind
and financial contributions from EFPIA companies
The EUPATI objectives are directly
contributing to this paradigm shift
Key objectives:
1.Develop
and disseminate objective, credible, correct and upto-date public knowledge about medicines R&D
2.Build
competencies & expert capacity among patients & public
3.Facilitate
patient involvement in R&D to collaborate in academic
research, industry research, authorities and ethics committees
…and NOT:
develop indication- or therapy-specific information!
EUPATI is developing education targeted
at different levels
EUPATI Patient Experts
Training Course
-- for expert patients
EUPATI Educational
Toolbox
-- for patient advocates
EUPATI
Internet Library
-- for the health-interested public
100
patient
experts
12.000
patient
advocates
100.000
individuals
English
English
French
German
Spanish
Polish
Italian
Russian
EUPATI Course, Toolbox and Library:
Media and Teaching Tools
EUPATI Patient Experts
Training Course
-- for expert patients
EUPATI Educational
Toolbox
-- for patient advocates
Development
2013-2015
Development
2014-2016


e-learning
Classroom style face to
face teaching

Slide shows,
factsheets, videos and
webinars, glossary
'print ready' content



EUPATI
Internet Library
-- for the health-interested public
Development
2014-2016



Encyclopaedia
Short video
documentaries
Patient interviews
micro-lectures (as
podcasts)
Images, diagrams
Topics that EUPATI will cover
1.Discovery
of Medicines & Planning of
Medicine Development
Testing and Pharmaceutical
Development
3.Exploratory
and Confirmatory
Clinical Development
4.Clinical
Trials
5.Regulatory
Affairs, Medicinal Product Safety,
Pharmacovigilance and
Pharmaco-epidemiology
6.HTA
+ Patients‘ roles and
responsibilities
2.Non-Clinical
principles and practices
10
Reflecting European diversity:
7 languages, 12 countries
7 most frequently
spoken languages:
•English
•French
•German
•Spanish
•Polish
•Italian
•Russian
12 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
Strong consortium
& strong governance





Coordinated by patients (EPF)
Leading pan-EU patient umbrella
groups involved in all key activities
Strong impetus from key academic partners
and research organisations
Industry expertise in medicines R&D
Advisory bodies & codes committed to
ensure independence and good
governance
•
•
EMA, Swissmedic, MHRA, BfArM, AIFA
Key experts in bioethics, genetics, HTA,
economics, evidence based med,
patient advocacy
Public license model guarantees
ownership and re-use by the public

What we bring in and what we produce
will be owned by the public

EUPATI material will be 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/
Project Plan
Confirmation Phase
M19-48
Preparation Phase
M1-18
Sustain Phase
M49-60
WP1
Coordination
Project
Infrastructure
Project Management, Communication,
Evaluation, Finances
WP2
Network
Implem.
Establishment of
EUPATI Network
Public conferences, Regional Workshops,
EUPATI Network, EUPATI National Platforms
WP3 Needs
Assessment
& Gap An.
WP4 Content
Dev.
WP5
IT Infrastr.
Needs analysis,
Review of material,
focus groups
Syllabus
Quantitative survey,
Literature review
Design, development and support of technical
infrastructure for eLearning/IT Platform
WP6 Deployment &
Quality
Assurance
WP7
Sustainability
Refinement,
quality
control
Editorial process, Content
Development, translation
First
course
performed
Research on Patient
Partnership models
Best practice guideline dev.,
Recommendation of new
teaching methods
Development of
code of conduct
for patient
involvement
EUPATI IT
Platform
launch
Sustainability concept dev.
Deployment,
dissemination,
quality
assessm‘t
New technologies and
future remit strategy
EUPATI National Platforms are
launching
The EUPATI National Platforms...
Ensure EUPATI understands educational needs in R&D on the
national level when developing content
Disseminate EUPATI’s existing training material and information on
the national level
Raise public interest about EUPATI in 12 countries
Identify training faculty, logistics and financial support on the
national level
Status:
National platforms launched in
UK, IE, ES, CH, LUX
National liaison teams in FR, IT, MT
AT, PL, DE, BE still challenging
Patient Expert Training Course
+
Online self-learning
+
2 Face-to-face events
Patient involvement
forum
150-175 hours of e-learning
and 8 days for two Face-to-Face meetings
over a period of 14 months
Selection Criteria

Quality of the individual motivation (35%)

Commitment to using and applying knowledge and skills acquired
during and after the completion of the Course (35%)

Experience related to the 3 EUPATI profiles - Patient Ambassador,
Patient Journalist, Patient Facilitators/Trainers (22.5%, i.e. 7.5% each)

Experience in interacting with stakeholders (7.5%)
Eligibility Criteria

Be a patient, i.e. either:
•
Employee or volunteer of a patient organisation
•
Patient with a chronic and/or lifelong illness/condition who is not affiliated with a patient
organisation
•
Family member/carer (not affiliated with a patient organisation) of a patient with a chronic
and/or lifelong illness/condition

Be living in the European Region according to the WHO definition

Commitment to the full training. Be able to:
•
Dedicate between 175 and 200 hours to study the complete e-learning course
•
Spend 8-10 days to attend the two face-to-face training sessions (8-10 days)
•
Actively participate in the online forum discussions during the entire duration of the Course

Application of knowledge and skills learnt to increase patient
representation, communication, or facilitate knowledge and education in
others

Basic experience/understanding of medicines R&D processes

Working knowledge of English (at least intermediate-level (B1 CEFR
is required)

High-speed internet connection.
Multi-stakeholder development and review
of the EUPATI materials
Internal production and review process
Content
Production
by experts
•
•
Editorial
Group
Review
Expert
Review
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 Testing
•
•
•
•
Project Advisor
Review
Ethics
Committee
Review
Regulatory
Expert Review
Health Literacy
Expert Review
Release
User-tested with target audience
Reviewed by independent Project Advisory Board members and
Ethics Committee members
Relevant topics reviewed by independent regulatory experts and HTA
experts
Edited for appropriate language by health literacy experts
The EUPATI e-Learning platform is
already in use with the course launch
20
EUPATI beyond 2016: Sustainability
when current funding ends is being discussed
What EUPATI should continue to do
after current funding ends:
Coordination
National
Content
EUPATI “Central project”
Training
PlatManageforms
ment
• Provision of the EUPATI course:
– Run the English-language
Patient Expert Training Course
– Provide the EUPATI Toolbox (IT platform)
– Provide the EUPATI Internet Library
(IT platform)
– Support matchmaking of EUPATI trainees
with interested parties
(researchers, authorities)
• Keeping EUPATI’s material up to date, e.g. when regulation changes
– Update the course material, the Toolbox, the Internet Library
(in all 7 languages)
– Continue to implement feedback of users e.g. corrections, terminology
• Extend content beyond the current syllabus (e.g. patient involvement in research)
Overall coordination and support of EUPATI’s National Platforms
• Coordinate the 12 National Platforms (& potentially additional countries)
• Support the conduct of local courses / other language courses
• Make sure EUPATI material derivatives do not deviate from EUPATI content
IT
Platform
Beyond EUPATI: Creating
sustainable impact beyond 2016
EUPATI is developing:

New and innovative concepts that will ensure more active
involvement of patient experts in R&D and HTA

Guidelines for interaction between stakeholders, ethical
principles and best practice procedures

Guidance on interaction of patient advocates with
regulatory, HTA bodies, researchers and industry in the area of
medicines research and development
can really make a unique
difference to patient
empowerment and to
medicines R&D.
You can help us to make
it a success.
Jan Geissler
jan@patientsacademy.e
u