PATIENTS – SCIENCE – INDUSTRY

March 7th, 2017

Derick Mitchell, PhD

May you live in changing times….

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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In a changing system - the two loops theory

Trailblazers

Protectors

Firefighters

Illuminators

Platform

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

Patient-led activities

Health Hacks

Workshops

Conferences

Consultations

Round-tables

Working Groups

Training Days

Rare Diseases

eHealth

Clinical Research

Health Information

Health Economics

Patient Registries

Biobanking

Top 10 things we can do…

1. Stimulate research

2. Engage with patients and families

3. Focus on what matters rather than what can be counted

4. Need for partnership between patients, academics, across stakeholders

5. Need appropriate protections and supports for patients and families

Top 10 things we can do…

6. Interpret data protection regulations sensibly and proportionately

7. Regulate proportionately

8. Build the capacity of patient organisations

9. Collect information systematically

10. Recognise the equity that underpins public healthcare system

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Source:  Geissler,  Ryll,  Leto,  UhlenhoppEPALCO/EUPATI  (2015,  unpublished)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

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!

Patient Narrative Project

Person-Centered, Coordinated Care

• A set of generic descriptors for what person-centred, coordinated care looks and feels like from the Irish service user perspective

• A definition for ‘person-centred coordinated care’ that is shared, understood and used by service users and staff at all levels of the health service in Ireland

Irish Patient Education Programme

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

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