Webinar of the European Patients' Academy on Therapeutic Innovation (EUPATI) held on 4 Nov 2013 to update participants of its focus groups about project progress, results of the qualitative research, and how the recommendations translate into content production and dissemination activities of the project.

1. EUPATI Update
to participants of the EUPATI Focus Groups
EUPATI Webinar
on 4 November 2013
- For presentation purposes only, not for further dissemination -
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.

2. Aims of webinar
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To provide webinar participants with an overview on the current status
of the EUPATI project
To provide feedback to webinar participants on the findings and
recommendations made from the focus groups that they participated
in at EUPATI events
To provide details of how the findings and recommendations from this
work have informed the development and implementation of the
EUPATI training course for patient advocates
To say thank you for your participation
2

3. Overview of today’s webinar
Topic
Speaker
Progress update on the status of EUPATI
Annamarie Dillon
Findings and recommendations from needs assessment
focus groups
Suzanne Parsons
Content development overview and response to
recommendations from focus groups
Niels Westergaard
Deployment and dissemination overview and response to
recommendations from focus groups
Liuska Sanna
Next steps and questions
Annamarie Dillon
3

4. EUPATI Project Update
4 November 2013
For presentation purposes only, not for further dissemination

5. European Patients' Academy on
Therapeutic Innovation…
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Public-Private Partnership of EU Commission and EFPIA
Launched February 2012, runs for 5 years
Patient-led, coordinated by European Patients’ Forum,
and EGAN, EURORDIS, EATG in leadership roles
Will develop and disseminate objective, credible,
correct and up-to-date public knowledge about medicines
R&D
A strong multi-stakeholder consortium of patient
organisations, academia, NGOs and industry –
30 organisations

6. By 2016, the Patients’ Academy
will…

develop and disseminate accessible, well-structured and userfriendly information and education on medicines R&D

build expert capacity by training patient advocates,
and enhancing capacities among patients and the public

create a leading public library on medicines R&D: translated into
7 languages, published under “creative commons license”

facilitate patient involvement in R&D to partner up with
academia,
authorities, industry and ethics committees
THAT WILL LEAD TO
- a paradigm shift in empowering patients and
the public to understand the medicines development
process and how to contribute to it
…we do not
offer indicationor therapyspecific
information!

7. Audiences: Advocacy leaders as
well as the general public
1
2
3
EUPATI Certificate Training Programme
Academic Modular Certificate Programme
Patient Ambassadors in various committees, R&D teams, …
Patient Journalists raising awareness
Patient Trainers for patient communities & networks
EUPATI Educational Toolbox


Educational tools for patient advocates
Variety of distributable formats: Paper-based booklets, ppt
presentations, eLearning, webinars, videos etc.
100
patient
experts
12,000
patient
advocates
EUPATI Internet Library


Patients & the general public, eg, on specific aspects of
the development process of medicines for patients with
little health literacy experience
Wiki, YouTube, films, cartoons, etc.
100,000
individuals

8. Task Forces within EUPATI
Project Secretariat
Network
Implementation
Needs
Assessment,
Gap Analysis
Content
Development
IT Infrastructure
Deployment &
Quality Control
Sustainability
Task Forces
Task Forces
Task Forces
Task Force
2.1 Establishment and
Coordination of the EUPATI
Network
4.1 Medicines development
process from research to
approval
5.1 Functional
specification
Communications
Task Force
2.2 Organisation of EUPATI
Conferences and Regional
Workshops
4.2 Personalized and predictive
medicine
5.2 Implementation of the
signed-off functional
specification
4.3 Drug safety and risk/benefit
assessment of (novel and
existing) medicines
5.3 Support and training
to defined users in
the organisation
4.4 Pharmacoeconomics and
health technology assessment
5.4 Handover of
infrastructure and
hosting of the portal
to EUPATI
2.3 Organisation of National
Liaison Teams to support
other WPs' activities
2.4 Design, management
and maintenance of a
digital communication
platform for all Network
Members
2.5 EUPATI Ethics Panel
4.5 Design and objectives of
clinical trials (& involved
stakeholders)
4.6 Patients' roles and
responsibilities in innovative
medicines development
(4.7) Editorial Board

9. European Patients’ Academy:
General Progress
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Website available in all 7 languages, collaboration tools established
Advisory Board meetings ongoing
Ethics Panel established, Ethics Framework finalised
“EUPATI Network” launched, National Liaison teams forming
Communications: Multiple presentations at conferences,
Communications plan in place
First conference held in Rome in March 2013
Needs assessment data analysis underway

10. European Patients’ Academy:
Progress in Work Packages
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Monthly EUPATI newsletters now available and active on social
media – join the discussions
10 out of 12 National Liaison Teams have drafted country maps
and have plans to engage individuals and groups on a national
level; April 2014 meeting in Warsaw, P, being planned
Needs assessment fieldwork completed; themes have been
identified and recommendations have been shared within the
project
Content for training course being developed
IT infrastructure and web platform being designed, user testing
will start soon
Selection criteria and application process for training course
being finalised
Examples of best practices / public private partnerships have been
identified, call will continue

11. Findings and
recommendations from
patient advocate focus groups
Suzanne Parsons, EUPATI WP3 Project Manager, Nowgen,
University of Manchester

12. Overview of needs assessment work
Review Work
Review of existing
information
resources on
medicines
development aimed
at patients and the
public
Review of research
literature on patients’
and the public’s
knowledge, attitudes
and beliefs regarding
medicines development
Online Surveys
General public across 6
European countries (GB,
Spain, Poland, Italy, France
and Germany)
Qualitative Studies
Patient advocates and
expert patients across
Europe
Of patients, public,
patient advocates,
pharmaceutical industry,
clinical research
professionals and policy
makers in UK, ES, PL
470 responses from
patient advocates and
expert patients across
Europe
148 reported current
research involvement
and 98 previous
involvement
125 commented on
PILs
70 involved in
identifying research
priorities
90 member of project
advisory group
Across all sites
Final report
Final report
Country reports
Findings
306 resources
submitted. 230
included in review.
Highest number of
resources covering
drug safety.
Lowest number
covering
personalised and
predictive medicine.
12600 titles and
abstracts reviewed
134 included in review.
Medicines development
(1 study
Personalised and
predictive medicine 52
studies
Medicines safety 28
studies
HTA 10 studies
Clinical trials 40 studies
7003 members of the public
surveyed
6931 responses recorded
Interest in learning more about
medicines developed areas had
a similar pattern in all countries
•Medicines safety
•Personalised and predictive
medicine
•Drug discovery
•HTA
•Clinical trials
•Patients roles and
responsibilities
•Regulation
•Pharmacoeconomics
91 patient advocates
34 members of the public
13 policy makers
20 pharmaceutical
industry representatives
23 Clinical research
professionals / Health
care academics
181participants I total
Reports
Information review
executive summary
and full report,
Interim report in Nov
2012
Evidence summary doc.
Methods and data doc.
Abstracts and interim
report
Final report Oct 2013
Methods and data document
Interim report
12

13. Aims

To explore patient advocates’ attitudes and information needs
regarding medicines development and their involvement in it
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Qualitative research approach used:
•
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Useful if there is little known about an issue
Best way of exploring key stakeholders’ perspectives and understanding and what
an issue means to them
13

14. Recruitment
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EUPATI meeting participants (Regional workshop; NLT meeting;
EUPATI Conference)
Information sheet and consent form
Conference organisers collected
•
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Organisation type
Disease area
Geographical scope
Experience of medicines development
14

15. Sampling
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Key sampling criteria – Patient organisation with a National, European
or International focus
Reported experience of medicines development (some experience
versus no experience)
15

16. Focus group topic guide
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Medicines development experience
How patient advocates support patients’ awareness of and
involvement in medicines development
Patient advocates information, training and support needs to increase
patients’ awareness of and involvement in medicines development
•
•
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For patient advocates
For patients at large
Barriers and facilitators to developing and / or improving patient
information
16

17. Focus groups undertaken
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5 FGs at regional workshop in Frankfurt, September 2012
1 FG at NLT meeting in Barcelona, March 2013
2 FGs at EUPATI conference in Rome, April 2013
53 patient advocates took part overall
17

18. Key Themes
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Role of patient advocates in general and in relation to medicines
development
Beliefs about patient involvement in the medicines development
process
Beliefs about information needs regarding the medicines development
process
•
•
•
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Training course content
Training course format
Additional areas which EUPATI Should cover
Beliefs about the quality and trustworthiness of the training and
information produced by EUPATI
18

19. Role of patient advocates in general
Multi-faceted role
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Support patients – day-to-day symptom management
Awareness raising of condition
Producing and disseminating information
Managing patient expectations regarding new treatments
Involvement in research
19

20. Role of patient advocates in research
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As participants
Recruiting participants
Providing advice about research participation
Facilitating links between doctors, patients, scientists and the
pharmaceutical industry
Influencing on a regulatory level
Being co-researchers
•
•
•
•
Organisers
Funders
Influencing research priorities
Developing patient information
20

21. Role of patient advocates in research
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As participants - ‘I also took part in a study and we…only time I saw
the doctor was one evening, had a doctor and study nurse explain the
study. And then I had to go to the study nurse every time’
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Recruiting participants - ‘I've participated in a short term clinical trial
myself but then I spent most of my time, like five years helping other
patients get into clinical trials’.
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Providing advice about participation – ‘We added all the clinical
trials which are going on and we informed the patient from the early
beginning what it means being part of a clinical trial. And now for our
organisation we have the same, we are working together with our
registry and they are all the specialists, the researchers; and we can
provide all our patients with ongoing trials’
21

22. Role of patient advocates in medicines
development
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Research involvement just one of the many roles played by patient
advocates
Need for realism and recognition of how patients can incorporate
playing an active role in medicine R&D into their many other roles
Importance of clarifying and communicating the roles that patients can
play in medicines development
Relationships are vitally important – everybody (including patients,
industry and academia) needs training in how to communicate with
each other, work together and respect one another’s perspectives
Feeling that industry can be unapproachable
Health professional still act as the gatekeeper to industry for many
patients
22

23. Role of patient advocates in medicines
development
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Relationships - All the times they [pharmaceutical companies] forget
to talk with the patients’ organisations first’
Perceptions of industry - I was with a pharmaceutical company in
Germany about a year ago, and they were developing a new
medication. They wouldn’t give us any information. They wouldn’t let
us anywhere near it. No cameras, nothing. They said it was all
commercially sensitive’.
Health professional as gatekeeper to industry - ‘Sometimes,
depends on the physicians. How do they inform the patients? If they
are open to information, they do follow the path of education on that. If
they do not inform them, they just don’t know what they are going
through. So it’s patients’ position depends on many other factors, not
just physicians’ approach…But in general, it’s basically still in the
hands of physicians, how they prepare patients for that occasion.’
23

24. Beliefs about patient involvement in
medicines development
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Some patient advocates/expert patients want to be professionalised,
others don't
•
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Feeling amongst some that having to take an accredited course could
be a barrier.
•
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“If I don't do it, I won't be seen as an expert, but I already am”.
Importance of patients’ knowledge about their own conditions being
taken into account and valued
•
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“I agree you have to professionalise otherwise you don’t score an effect”
‘Patient groups are our expert patients’
Patients’ needs and expectations regarding involvement may vary
depending on their condition and their prior experiences of
involvement in medicines development
Different needs of patient advocates depending on the condition they
represent
•
‘There are different needs behind different diseases’
24

25. Information should be…
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Accurate and up-to-date
Quick and easy to navigate
Easy to judge that it is high quality
Developed by a credible source which is trustworthy, pan-European
and driven by patients
Quality stamp – impartial, trustworthy information
Jargon free
Simple, easy to understand and ‘straight to the point’
25

26. Training courses content
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Increasing content knowledge will increase patients’ confidence in
getting involved in medicines development
•
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Support and training to work effectively work with industry and other
stakeholders essential, eg, training in influencing skills
“Rome wasn't built in a day”: a gradual approach is necessary to
what is essentially a culture change
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‘What we need to do is try to educate our patient representatives to feel at home in
this kind of tables and boards. So the people can consider them as peers.’
‘Just like magic bullets are not always evident in medicines development, a training
course alone is not going to ‘solve’ misconceptions and myths and help people to
learn how to work effectively with one another.’
“Pick and mix”: Need for training about medicines R&D expressed
but they do not necessarily want to be trained in all aspects.
Advocates should be informed of their rights as patients
•
‘The patient group should advocate also and promote patient’s rights because
although patients might not have the knowledge on innovative medicines and
development in the medicines scene but they have to be well informed of their rights
26

27. Training courses content
Further information required on:
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Science behind / scientific aspects of studies eg, HTA, Drug safety,
Benefits and risks of involvement
Importance of defining roles for patients in medicines development
Empowering and supporting patients to become involved and engaged in
medicines development and to judge whether information is useful
Transparent information about the results of trials
Patient-reported outcomes
How the cost of medicines is determined
How pharmaceutical companies decide where to invest their resources
Scientific terminology
•
‘I don’t have a scientific background at all, so when we try and get into discussions
with scientists or pharma-companies or whoever it is that is dealing with drug
development, be it governmental bodies or regulatory agencies, we lack this
vocabulary. We lack the basic scientific knowledge that empowers us to be able to
direct things in the way we want’.
27

28. Training courses format
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Face to face elements provide “validation”; however, there is a danger of
“decay” - not being able to use training soon after its delivery.
Importance of communicating the roles that patients can play in medicines
development
Expert level courses can be difficult to follow: importance of prior preparation
and guidelines for speakers
Importance of refresher courses in a rapidly changing area
For elements of the course to be delivered by fellow patient advocates
•
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‘Patients believe more the experience from their peers.’
Case studies are useful:
• From basic research to post-marketing
• Examples of successful/unsuccessful involvement in research
• To allow patient advocates to learn from each other
28

29. Delivery of training courses
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Importance of using virtual methods of delivery
29

30. Recommendations to content
development team
Degree of emphasis placed on some modules compared to others
That the time devoted to each module is clarified and communicated
both to patients and to those developing the module
Roles of patients within the medicines development process
That the training course syllabus should more precisely define or
describe the roles of patients in the medicines development process or
where they don’t currently exist, what such roles might be
That the current roles that patients have played within the medicines
development process are documented and communicated within the
training course – Examples of current good practice in involvement
That patients with experience of involvement in medicines development
are able to contribute to the teaching of the Expert Level course
30

31. Recommendations to content
development team
Quality, credibility and impartiality of the information and training
produced by EUPATI
To ensure that EUPATI content is viewed as credible and trustworthy
that the process of producing, reviewing, assessing and user testing
EUPATI content should be clearly outlined and made available
Support and training for partnership working between patient
advocates, industry and other key stakeholders
To ensure that the course enables participants to have ‘hands on’
practice of the course content
31

32. Recommendations to content
development team
Recommendations on course content
That course content clearly describes patients’ roles and responsibilities
within medicines development
Current low awareness but high interest levels in personalised /
stratified medicine suggest that this is an area of great interest
Content on the roles of the various key stakeholders in medicines
development will be important to include as greater knowledge of this will
facilitate greater patient involvement in medicines development
Importance of course covering how patients can be involved in early
research and development, eg, in setting research priorities
Patient advocates are particularly interested in how to interpret clinical
research evidence. This is an area of importance for the course
32

33. Recommendations to deployment and
dissemination team
Recommendations on application process for expert level training
course
Importance of ensuring that the course application process is as
inclusive as possible, enabling as wide a range of participants in terms of
their experience of medical research and medicines development, their
perspectives and the condition they represent to take part
33

34. Work Package 3 team
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University of Manchester
Bella Starling – WP3 lead
Suzanne Parsons – WP3 Project Manager
Su-Gwan Tham – WP3 Project Assistant
GlaxoSmithKline
Kay Warner – WP3 co-lead
Novo Nordisk
Christine Mullan-Jensen – WP3 Deputy Co-lead
EGAN / GAUK
Kim Wever
Celine Lewis
Amgen, Genzyme, Roche, AstraZeneca, VFA
34

35. Get to know us!
Web:
www.patientsacademy.eu
Twitter: @eupatients
as well as:

36. Building Knowledge & Capacities for
Patients’ Involvement in Medicines
R&D
Niels Westergaard, PhD, DSc
Biopeople
University of Copenhagen
Denmark
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.

37. Audiences: Advocacy leaders as
well as the general public
1
2
3
EUPATI Certificate Training Programme
Academic Modular Certificate Programme
Patient Ambassadors in various committees, R&D teams, …
Patient Journalists raising awareness
Patient Trainers for patient communities & networks
EUPATI Educational Toolbox


Educational tools for patient advocates
Variety of distributable formats: Paper-based booklets, ppt
presentations, eLearning, webinars, videos etc.
100
patient
experts
12,000
patient
advocates
EUPATI Internet Library


Patients & the general public, eg, on specific aspects of
the development process of medicines for patients with
little health literacy experience
Wiki, YouTube, films, cartoons, etc.
100,000
individuals

40. First version of the syllabus: 133 Topics
F2F and eLearning
•2 x 4 days F2F
•240 h of eLearning
Topics:
Topics:
Heavy: 2-6 h
Heavy: 2-6 h
or
or
Light: up to 2 h
Light: up to 2 h

41. Learning outcomes condensed

42. Basic Principles of Medicine Discovery and Development
The concept of Bioavailability and Bioequivalence

44. Deployment and Quality
Assurance
EUPATI Work Package 6 Update

45. WP6 Objectives
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To implement the EUPATI expert, education and information
programmes at European and national levels with the three patient
audiences: 100 patient experts, 12,000 patient advocacy leaders and
100,000 patients at large
To disseminate the availability of the programmes widely
To assure high quality standards in development and implementation
of training content and courses
To monitor and evaluate on an on-going basis the quality and impact
of the programmes’ delivery

46. WP6 Activities

Development and implementation of Communication Strategy for
dissemination of programmes
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Programme roll out for all 3 EUPATI audiences

Monitoring and evaluation on an on-going basis; the quality and
impact of the programmes’ delivery (online tools, surveys, focus
groups, interviews)

47. WP6 Deliverables

48. Progress update

Communication strategy being drafted – to be completed by end of
November

Audience 1 - Patient Experts:
Programme of F2F training component being developed
Recruitment procedure being drafted – recruitment to be launched in
January 2014
•
•

49. Recruitment Audience 1
Eligibility
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Individual Employee of a patient organisation who does not have the condition
represented by the patient organisation
Employee of a patient organisation who has the condition represented by the
patient organisation
Volunteer of a patient organisation who does not have the condition
represented by the patient organisation
Volunteer of a patient organisation who has the condition represented by the
patient organisation
Patient with a chronic and/or lifelong condition who is not affiliated to a patient
organisation and who participates in policy/projects/activities/committees/etc.
to represent his/her personal experience as patient and/or the perspective of a
patient group
Family member of a patient with a chronic and/or lifelong condition who is not
affiliated to a patient organisation and who participates to
policy/projects/activities/committees/etc. to represent the experience of his/her
relative and/or the perspective of a patient group.
OPEN to ALL EUROPEAN COUNTRIES

50. Recruitment Audience 1
Selection criteria
1)
Individual motivation
2)
Commitment to complete training
3)
Commitment to use and apply learning
4)
Good knowledge of English
1)
Experience of being involved in medicines research and development
2)
Experience related to the three EUPATI profiles
3)
Country of origin – Open to all Europe
4)
Disease area
5)
Being a patient/informal carer

51. Selection procedure
1)
Review of compliance with eligibility criteria + completeness of
application package (WP6)
2)
Selection done by ad-hoc Committee consisting of 5 members: 3
representatives of the EUPATI Consortium (1 patient organisation, 1
academia and 1 industry), one member of the EP and one member of
the PAB.
3)
Applications shortlisted to be revised independently by each member
4)
F2F meeting to decide final assessment of applications and selection
5)
Communication to all applicants on the result (WP6).

52. Next steps and questions
Web:
www.patientsacademy.eu
Twitter: @eupatients
as well as: