EUPATI Patient Expert Training Course and it Relevance for Patient

Involvement

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.

Niels WestergaardBiopeopleUniversity of Copenhagen

Open dialogue with 3 students – Q/A session

Patient focused medicines development: Introducing a paradigm shift

Industry

Patients

Clinic/Academia

Regulators

Shared goal:Getting the right treatment to the

right patients

TodayAre largely unaware about: • Clinical trials• Translational research• Personalized medicine• Pharmacoeconomics • Their potential supportive roles in

those areas

EUPATI Vision for 2020Educate patients to be active in the Drug Development process – from A-Z• Participation in clinical trials • Protocol design• Informed consent• Ethical review process, • Marketing authorization, • Value assessment • Healthcare policy• Others

Patient focused medicines development: Introducing a paradigm shift

Objectives of EUPATI

Primary objectives• Implementing the European Patients’ Academy,

empowering patients to be involved in all stages of medicines R&D• Building capacity by training independent, empowered patients

(advocates)• Making patient centricity of medicines R&D a reality

Important outcome: • This is all about achieving better public health and better drugs, not

about individual interests • To implement a true partnership of patients, academia and industry

and regulators• Patients actively and systematically involved in all stages of medicines

R&D, across diseases, stakeholder groups and country borders

EUPATI Patient ExpertsTraining Course-- for expert patients

EUPATI develops education targeted at different levels

50+50patient advocates

EUPATI Educational Toolbox-- for patient advocates

EUPATI Internet Library-- for the health-interested public

English FrenchGermanSpanishPolishItalian Russian

English

The goal for EUPATI

EUPATI will provide scientifically reliable, objective, comprehensive information on medicines development from A to Z to be used by patients and patients organizations across Europe to increase their capacity to be effective advocates and advisors

The material will be neutral i.e.

• Not disease specific• Not medicine specific• Not pharma specific

Important

STRUCTURE

plus

Online self-learning combined with 2 face-to-face meetings

150-175 hours of e-learning and 8-10 days for two F2F meetings

Overview of the course modules

Module 1Discovery of medicines and Planning of Medicines Development

Module 2 Non-Clinical Testing and Pharmaceutical Development

Module 3 Exploratory and Confirmatory Clinical Development

Module 4 Clinical Trials

Module 5Regulatory Affairs, Medicinal Product safety, Pharmacovigalence and Pharmacoepidemiology

Module 6 Health Technology Assessment (HTA) principles and practices

Oct 2014

Dec Feb Mar Nov Jan 2015

Apr May Jun SepJuly Aug Oct Nov Dec

Module 1

Module 2

Module 3

Face to Face event 1

Face to Face event 2

Module 5

Module 6

Module 4

Module 1 QUIZ

Module 2 QUIZ

Module 3 QUIZ

I IIIII

EUPATI Patient Expert Training Course 1st Cycle Oct 2014 – December 2015

Students at the EUPATI Patient Expert Training Course!

Are part of something unique!• There has never been a course in a similar depth offered to (lay) patients.• This course has been developed from scratch.

Are pioneering this course!• Your feedback on this pioneer work will be essential.

We have a lot to learn from you too.

Will be patient ambassadors in R&D !• get in-depth knowledge to give a meaningful contribution to the medical community • have the tools to help to provide better medicines to patients. • be equipped for a broader dialogue around future patient involvement in R&D

How was training material developed

Developing the syllabus (100 topics) Involving process; NGO, Patient reps., academia and industry

Developing the content 6 task forces, knowledgeable people in the given fields

Editing the content All material has been reviewed: patient perspectives

User testing 20% of the total e-learning course;

Regulatory review Highest standards in terms of quality, objectivity and credibility

Readability and health literacy check Secure right literacy level for trainees where English is their second or third

language

Multi-Stakeholder Development of the EUPATI materials Conten

t Production by experts

Expert

Review

Editorial

Group Revie

wUser Testing

Project Advisor Review

Ethics Co

mmittee Review

Regulatory Expert

Review

Health

Literacy Expert

Review

Release

Internal production and review process

External testing and review process

• user-tested with target audience• reviewed by independent Project Advisory Board members and

Ethics Committee members• reviewed by independent regulatory experts• edited for appropriate language by health literacy experts

• 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.

Assessment

Unrecorded knowledge checks(1-2 questions after each e-lesson; unlimited attempts; no pass mark)

End-of-module quiz (six in total)(20-40 questions after each module; 70% pass mark; 3 attempts, and if you fail, at least three days must pass before you can make a new attempt)

Engagement during face-to-face assessment and Reflective Questions on Patient Involvement

(Kim Wever will provide an explanation in her presentation)

Module 1 topics (syllabus topics)

1. Health and disease2. The concepts of incidence and prevalence3. The concept of personalised/stratified medicine4. Basic principles of medicines discovery and development5. Needs for development of new medicines for special populations6. Types of medicines, their mode of action and use7. The concept of efficacy and safety of medicines8. The concept of evidence-based medicine and outcomes research9. Types of collaborations in medicines discovery and development10. Principles of translational medicine11. End of Module Quiz

Learning outcomes module 1

1AExplain the importance and describe the possible role of patients/patient organizations in medicines development

1BDescribe the process of drug discovery and development and identify the critical factors and decision points, including patenting, and drug development in special populations

1CDescribe the background to the development of regulation of medicines and the roles of the various stakeholders

1D Discuss the role of biomarkers in drug development

1EDiscuss the potential application of the concept of personalized/stratified medicine in the medicine development process

1F Discuss the role of translational research in drug development

1G Outline the concepts of evidence based medicine and outcomes research

1HDescribe predisposing factors and underlying mechanisms of disease and the different types of medicines and their mode of action

Rationale face-to-face events

The EUPATI Patient Expert Course uses a blended learning approach of online and face-to-face training divided into 6 modules

This format allows trainees to complete a large part of the training at a time and place that they find convenient.

F2F sessions designed to allow trainees • To learn more about clinical trials (ethical considerations, use of

statistics, regulatory issues, pharmacovigilance, HTA. • To share their experiences.• To discuss patient involvement with each other and with the trainers.

Overall structure of the events

Two face-to-face events are planned• March 29 to April 2, 2015 = Event 1• September 14 to 18, 2015 = Event 2

Event 1 will cover clinical trials, ethics, statistics and regulatory issues.

Event 2 will cover benefit/risk, pharmacovigilance and HTA.

The sessions are either plenary, small group or hands on.

Expectations of the trainees

Require pre-reading online prior to each event.

Require preparation of small group session documents prior to each event.

Trainees will take on a pro-active role and must be present throughout all sessions.

EUPATI’s Patient Experts Training Course began 6 Oct 2014

Open to patients, carers, patient advocates and volunteers Two cycles of 50 participants

• Oct 2014 (1st 53 trainees), • Sept 2015 (2nd ~50 trainees)

By the application deadline for the first 50 trainees, more than 300 applications were received. Great demand from the patient community!

Selection carried out by selection panel based on solid criteria

e-Learning

EUPATI Training Programme10/2014 – 11/2015

Application Phase

3-4/2014e-Learning F2f e-Learning f2f

Internet Library

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