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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.
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EUPATI Webinar on 4 November 2013
- For presentation purposes only, not for further dissemination -
EUPATI Update to participants of the EUPATI Focus Groups
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.
Aims of webinar
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
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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
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4 November 2013
EUPATI Project Update
For presentation purposes only, not for further dissemination
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
European Patients' Academy on Therapeutic Innovation…
develop and disseminate accessible, well-structured and user-
friendly 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
By 2016, the Patients’ Academy will…
…we do notoffer
indication- or therapy-specific
information!
EUPATI Certificate Training ProgrammeAcademic Modular Certificate ProgrammePatient Ambassadors in various committees, R&D teams, …Patient Journalists raising awarenessPatient Trainers for patient communities & networks
Audiences: Advocacy leaders as well as the general public
100 patient
experts
12,000patient advocates
100,000individuals
EUPATI Educational Toolbox Educational tools for patient advocates Variety of distributable formats: Paper-based booklets, ppt
presentations, eLearning, webinars, videos etc.
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.
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Task Forces within EUPATI
Network Implementation
Needs Assessment, Gap Analysis
Content Development
IT InfrastructureDeployment & Quality Control
Sustainability
Project Secretariat
Task Forces
4.1 Medicines development process from research to approval
4.2 Personalized and predictive medicine
4.3 Drug safety and risk/benefit assessment of (novel and existing) medicines
4.4 Pharmacoeconomics and health technology assessment
4.5 Design and objectives of clinical trials (& involved stakeholders)
4.6 Patients' roles and responsibilities in innovative medicines development
(4.7) Editorial Board
Task Forces
5.1 Functional specification
5.2 Implementation of the signed-off functional specification
5.3 Support and training to defined users in the organisation
5.4 Handover of infrastructure and hosting of the portal to EUPATI
Task Forces
2.1 Establishment and Coordination of the EUPATI Network
2.2 Organisation of EUPATI Conferences and Regional Workshops
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
Task Force
Communications Task Force
European Patients’ Academy:General Progress
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
European Patients’ Academy: Progress in Work Packages
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
Suzanne Parsons, EUPATI WP3 Project Manager, Nowgen, University of Manchester
Findings and recommendations from
patient advocate focus groups
Review Work Online Surveys Qualitative Studies
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
General public across 6 European countries (GB, Spain, Poland, Italy, France and Germany)
Patient advocates and expert patients across Europe
Of patients, public, patient advocates, pharmaceutical industry, clinical research professionals and policy makers in UK, ES, PL
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 reviewed134 included in review. Medicines development (1 studyPersonalised and predictive medicine 52 studiesMedicines safety 28 studiesHTA 10 studiesClinical trials 40 studies
7003 members of the public surveyed6931 responses recordedInterest 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
470 responses from patient advocates and expert patients across Europe148 reported current research involvement and 98 previous involvement125 commented on PILs70 involved in identifying research priorities90 member of project advisory group
Across all sites 91 patient advocates 34 members of the public13 policy makers20 pharmaceutical industry representatives23 Clinical research professionals / Health care academics181participants 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 documentInterim report
Final report Final report Country reports
Overview of needs assessment work
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Aims
To explore patient advocates’ attitudes and information needs regarding medicines development and their involvement in it
Qualitative research approach used:• 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
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Recruitment
EUPATI meeting participants (Regional workshop; NLT meeting; EUPATI Conference)
Information sheet and consent form Conference organisers collected
• Organisation type• Disease area• Geographical scope• Experience of medicines development
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Sampling
Key sampling criteria – Patient organisation with a National, European or International focus
Reported experience of medicines development (some experience versus no experience)
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Focus group topic guide
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• For patient advocates• For patients at large
Barriers and facilitators to developing and / or improving patient information
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Focus groups undertaken
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
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Key Themes
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
• 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
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Role of patient advocates in general
Multi-faceted role• Support patients – day-to-day symptom management• Awareness raising of condition• Producing and disseminating information• Managing patient expectations regarding new treatments• Involvement in research
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Role of patient advocates in research
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
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Role of patient advocates in research
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’
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’.
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’
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Role of patient advocates in medicines development
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
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Role of patient advocates in medicines development
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.’
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Beliefs about patient involvement in medicines development
Some patient advocates/expert patients want to be professionalised, others don't
• “I agree you have to professionalise otherwise you don’t score an effect”
Feeling amongst some that having to take an accredited course could be a barrier.
• “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
• ‘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’
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Information should be…
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’
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Training courses content
Increasing content knowledge will increase patients’ confidence in getting involved in medicines development
• ‘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.’
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 ‘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
Training courses content
Further information required on: 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’.
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Training courses format
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
• ‘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
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Delivery of training courses
Importance of using virtual methods of delivery
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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 processThat 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 beThat 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 involvementThat patients with experience of involvement in medicines development are able to contribute to the teaching of the Expert Level course
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Recommendations to content development team
Quality, credibility and impartiality of the information and training produced by EUPATITo 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
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Recommendations to content development team
Recommendations on course contentThat 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 interestContent 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 developmentImportance 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
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Recommendations to deployment and dissemination team
Recommendations on application process for expert level training courseImportance 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
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Work Package 3 team
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
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Get to know us!
Web:www.patientsacademy.eu
Twitter: @eupatients
as well as:
Niels Westergaard, PhD, DScBiopeopleUniversity of CopenhagenDenmark
Building Knowledge & Capacities for Patients’ Involvement in Medicines
R&D
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.
EUPATI Certificate Training ProgrammeAcademic Modular Certificate ProgrammePatient Ambassadors in various committees, R&D teams, …Patient Journalists raising awarenessPatient Trainers for patient communities & networks
Audiences: Advocacy leaders as well as the general public
100 patient
experts
12,000patient advocates
100,000individuals
EUPATI Educational Toolbox Educational tools for patient advocates Variety of distributable formats: Paper-based booklets, ppt
presentations, eLearning, webinars, videos etc.
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.
1
2
3
First version of the syllabus: 133 Topics
F2F and eLearning•2 x 4 days F2F•240 h of eLearning
Topics:Heavy: 2-6 horLight: up to 2 h
Topics:Heavy: 2-6 horLight: up to 2 h
Learning outcomes condensed
Basic Principles of Medicine Discovery and Development
The concept of Bioavailability and Bioequivalence
Deployment and Quality Assurance
EUPATI Work Package 6 Update
WP6 Objectives
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
WP6 Activities
Development and implementation of Communication Strategy for dissemination of programmes
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)
WP6 Deliverables
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
Recruitment Audience 1Eligibility
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
Recruitment Audience 1Selection 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
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).
Next steps and questions
Web:www.patientsacademy.eu
Twitter: @eupatients
as well as:
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