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  you!Sarunas.Narbutas@pola.lt