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: