The#EuropeanPatients’#Academy (EUPATI) HTAinvolvement · 2018-05-22 · Research#subject...
Transcript of The#EuropeanPatients’#Academy (EUPATI) HTAinvolvement · 2018-05-22 · Research#subject...
28 October 2017
The European Patients’ Academy(EUPATI)
HTA involvement
Public
Research Ethics Committees
Competent authorities
Policy makers/Research Policy
HTA agencies& committees
Research subject
Info provider
Advisor
Reviewer
Co-researcher
Driving force
Clinical Research
Patients have a key role in all aspects ofhealth-related research
Trial protocol design, informed consent, ethical
review, marketing authorization, value
assessment, health policy
When You Ask Patients and When YouDon‘t
EUPATI: Paradigm shift in empowering patients on medicines R&D
} Launched Feb 2012 as a public private partnership, 33 consortium members,Funded by Innovative Medicines Initiative
} has developed and disseminateobjective, credible, correct and up-to-date public knowledge about medicines R&D
} is building competencies & expert capacity among patients and the public,
} has been a game changer and driver of patient engagement in R&D
} Continues as a permanent educational programme
EUPATI Patient ExpertsTraining Course-- for expert patients
EUPATI is developing education targetedat different levels
EUPATI Educational Toolbox-- for patient advocates
EUPATI Internet Library-- for the health-interested public
English FrenchGermanSpanishPolishItalian Russian(Romanian)(Portuguese)
English 1.Discovery of Medicines
2.Pre-clinical Development
3.Clinical Development
4.Clinical Trials 5.Regulatory Affairs, Drug Safety, Pharmaco-vigilance
6.Health Technology Assessment
The EUPATI Patient Expert Training Course
The EUPATINational Platforms
18+ EUPATI National Platforms
EUPATI National Platforms...n bring all stakeholders together in countriesn address educational needs in R&Dn disseminate EUPATI’s training material to patient organisations
National platforms set up in AT, FR, DE, IE, IT, LU, MT, PL, ES, CH, UK, DK, SK, PTAdditional platform initiatives ongoing NO, GR, RO, SRB, SE
What are ENPs doing?
ENP social media campaigns
ENP learning webinars
ENP workshops & conferences
ENP MoUs with partnersENPs on the TV
ENPs in the papers
EUPATI Guidances to support the interaction with patient organisations in R&D
EUPATI has developed guidances for the interaction of patient organisations with stakeholders n in industry-led R&Dn in HTA bodiesn in regulatory processesn in ethics committees
Available for download atà EUPATI.eu > Resources > Guidances
This is what we want to see happen
This is what we offer in exchange
Two simple basic principles!
Scientific involvement and policy work must go together
If you could learn it, I can learn it, too
Existing Examples of Patient Contribution to CT
n Draft patient friendly Informed Consent• Informed consent was approved by Bioethics Committee in Germany for the EUROSKI clinical trial Phase IV clinical trial for CML patients on discontinuation of TKI
n Include questions about complimentary and alternative medicines (CAM) in trial participant questionnaires• Discussions on-going with EORTC, addressed by EUPATI
n Use smart phone apps to monitor adverse effects, ask for patient reported outcomes• Developed in USA, several initiatives in EU (Andaman7)
n Encourage patients to log all the details that are relevant to their health• Nutrition disorders• Interactions with other drugs• Adverse reactions• Symptom management
2017-11-27Šarūnas Narbutas, ECPC 15
Patient involvement in practicewithin the R&D life cycleSource: Geissler, Ryll, Leto, Uhlenhopp – www.eupati.eu
Source: Geissler, Ryll, Uhlenhopp, Leto (2016): www.eupati.eu
Thank [email protected]