PATIENTS – SCIENCE – INDUSTRY

March 6th, 2017

Derick Mitchell, PhD

Overview

• IPPOSI?

•What do Irish people think about clinical trials?

•What do we mean by patient involvement in trials?

IPPOSI? Who?IPPOSI

A patient-led organisation that works with patients, government, industry,

& science to put patients at the heart of health innovation

Priorities

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Actively advocate for improved + equitable patient access to Health Innovation

Promote meaningful patient involvement in Health Research and Policy

Irish public perception

Irish  general  public’s  attitude  towards  clinical   research

Conclusions

Public  Survey

• Limited understanding of how one can participate (donating blood/tissue, medical info.)

• Ethical concerns

• Unnecessary Risk

IPPOSI  patient  members  (anecdotal)

(➕)• Access to innovative medicines &

technologies• Improved quality of care

(➖)• Benefit : Risk• Randomization• Compassionate Use• Ending of trial

Public information campaignclinicaltrials.ie

Patient involvement in clinical trials

Distinct from:• Recruitment of people as participants• Raising awareness• Sharing knowledge• Creating a dialogue with the public

Active partnership between members of the public and researchers in the clinical research process

Practical “Roadmap” on patient involvement in R&D

Research designand Planning

Design of Protocol

Informed Consent Study reporting

Post-study communication

Patient Info Leaflet

Trial steering committee

Investigators Meeting

Level  of expertise in  thedisease area required:mediumhigh    

Data Monitoring Committee Practical considerations

Health Technology Assessment

Protocol Synopsis

Researchpriorities

Settingresearchpriorities:

Information to trial participants

Research conduct andoperations

Regulatory affairs

Dissemination,communication,post-approval

Source:  Geissler,  Ryll,  Leto,  UhlenhoppEPALCO/EUPATI  (2015,  unpublished)

Fundraisingfor research

Ethics Review

Will it make any difference?

Patient involvement can:• Provide a different perspective

• Make language + content of trial information clear and accessible

• Help to ensure trial methods are acceptable and sensitive

• Help ensure that trial uses outcomes that are important to the public

• Help increase participation in research in general

Patient‘s organisations have unique insights in “real life“ and “real needs“ of patients:

Clinical Research DesignPriority SettingResearch Policy

Building a new environment for research

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Educated Patient Communities

IPPOSI Training for Members

• Clinical Research• Health Technology Assessment• Pharmaceutical Code of Practices• Health Informatics (coming soon!)

EUPATI produces Expert Patients on Medicines R&D

• Training & Education• Disseminates through national platforms

Areas covered by the Patients’ Academy

1.Medicines development process from research to approval

2. Personalized and predictive medicine

3.Drug safety and risk/benefit assessment of medicines

4. Pharmaco-economics, health economics and health technology assessment

5. Design and objectives of clinical trials (& roles of stakeholders)

6. Patients roles & responsibilities in medicines development

…and NOT:develop indication-­or therapy-­specific

information!

EUPATI Toolbox – www.eupati.eu

EUPATI  Toolbox  – Content  available

Infographics

Articles

Fact  sheets

PowerPoints

Videos

Roles change as a result of EUPATI course- creating patient leadersRole Before EUPATI After

Member  of  patient  organisation,  not  actively  involved 17% 2%

Active  role  in  a  patient  organisation 62% 71%

Leadership  role in  a  patient  organisation 62% 71%

Employee  of  a patient  organisation 25% 23%

Volunteer role  in  a  patient  organisation 60% 67%

Presenting at  conferences,  workshops  etc. 63% 83%

Advising  a  pharmaceutical company 13% 44%

Advising  a  regulatory agency 21% 42%

Advising  a  reimbursement agency 4% 8%

EUPATI  Fellows  are  increasingly  taking  leadership  roles  and  are  engaging  with  pharma,  regulators  and  HTA  bodies.  

Role  changes  also  imply  identity  shifts.

Everyone is different!

Researchers need support too

• Why?• Understand PPI and where it can be most effective in their work• Participation vs Engagement vs Involvement?

• How?• Bring together PPI info + resources relevant to your research in one place• Guidance on methodologies / practices• How to ensure it is meaningful? - Planning + Preparing

• Who?• Access people affected to be involved in your research

PriOriTY project  on  trial  recruitment • Top  10  questions  for  research  into  

recruitment  to  randomised trials

• Supported  by  James  Lind  Alliance  and  HRB-­‐TMRN

• IPPOSI  +  EUPATI  fellow  on  Steering  Committee

• Top  10  finalised at  F2F  Workshop  in  Birmingham,  Dec  2016  

• Dissemination  based  around  International  Clinical  Trials  Day,  May  20th,  2017

Take Home Messages

Patient involvement can improve research quality

Education + Training of both patients & researchers is key

Support patient networks, communities & spread the word!

@IPPOSI www.ipposi.ie