October 17th, 2017

PATIENTS – SCIENCE – INDUSTRY

Sustaining patient engagement resources - public-private platforms

Derick Mitchell

My Talk

1. IPPOSI?

2. Patient Involvement in Medicines R&D

3. How patient orgs & industry can interact

4. Generating patient-based evidence

Evidenced-based patient advocacy?

Collaborative sensemaking

“We are witnessing the collapse of expertise and the

rise of collaborative sensemaking”

David Holzmer

IPPOSI? Who?IPPOSI

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

& science to put patients at the heart of health innovation

IPPOSI Priorities

20

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

Our Resources

INFORM ENGAGE EMPOWER

Incorporating the patient voice

• Hierarchical Rhetoric

• ‘Walking the walk’ at the highest possible level

Challenges:• Decision-makers never want to change their processes

• Patients are not trained in health policy, dialogue

• Many patient orgs are not focused on policy/R&D issues

“The perfect is the enemy of the good”

What do patient advocates want re: medicines R&D?

That the patient voice is listened to

• To be involved as early as possible in clinical research design, priority setting, policy

• To improve the quality of clinical research - less wastage

• To ensure better use/reuse of research outputs and tools

• To generate impact and burden data to support the results of the clinical trials

• To use online / ehealth / mobile health apps to generate patient-based evidence

Practical “Roadmap” on patient involvement in medicines R&D

Research design

and Planning

Design of Protocol

Informed Consent Study reporting

Post-study communication

Patient Info

Leaflet

Trial steering committee

Investigators Meeting

Level of expertise in the disease area required:

mediumhigh

Data Monitoring Committee Practical

considerations

Health Technology Assessment

Protocol

Synopsis

Research

priorities

Setting

research

priorities:

Information to

trial participants

Research conduct and

operations

Regulatory affairs

Dissemination,

communication,

post-approval

Source: Geissler, Ryll, Leto, Uhlenhopp (2017)Therapeutic Innovation & Regulatory Science. (doi: 10.1177/2168479017706405)

Fundraisingfor research

Ethics Review

Where do we want to get to?

http://www.ema.europa.eu/ema/index.jsp?curl=pages/partners_and_networks/general/general_content_001738.jsp&mid=WC0b01ac0580b15dc7

How patients, industry can interact on R&D

• Move from obsessive use of compliance to measuring the value of interaction

• Look at legislation, regulation, codes of conduct and see what needs to be changed

• Avoid rhetoric of ‘patient voice’ – not matched by reality

Challenges to interacting

• Lack of Trust

• Lack of mutual learning

• Perceived (or real) legal barriers, conflict of interest

• Silo-thinking, finger-pointing

• Lack of standardized metrics to measure impact and benefits of patient

involvement

• Lack of capacity and training in patient organisations

• Over-compliance

Basic Rules

• Trust and transparency

• All that patient organisations have is their credibility

• They must also be effective and feel trusted

Transparency and Independence

• Basic principles, values = existing codes are good

• Achieve financial transparency

• Maintain independence

• Rules for reputation and credibility

Guidance on industry interaction

• Identify roles and opportunities for patients to interact in a systematic way

• Guidance on:

• Defining the patient

• Defining the interaction

• Ways for Identifying patients

• Writing collaboration agreements

• Rules of compensation

• Transparency & Disclosure

• Events & Hospitality

• Appendices: Roadmap for PPI; Codes; Confidentiality agreement, Written agreement

A framework of patient engagement

Engages

Empowers

Educates

Evaluates

Evolves

A framework that enables structured, effective, meaningful, ethical, innovative, and sustainablepatient engagement

(and demonstrates the ‘return’ on this engagement for all actors)

IPPOSI & The European Patients Academy

• EUPATI produces Expert Patients on Medicines Research & Development

• Provides Training & Education

• Disseminates through national platforms

The project received 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.

www.eupati.eu

18+ EUPATI National Platforms

• Bring all stakeholders together in countries

• Address educational needs in R&D

• Disseminate EUPATI’s training material

National platforms now established in:

AT, BE, FR, DE, IE, IT, LU, MT, PL, ES, CH, UK, DK, SK, PT, NO, RO, GR

Additional platform initiatives ongoing in Serbia, Brazil, Japan

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.

First Irish Patient Education Programme

7-month-pilot programme in Health Innovation

3 Modules – Clinical Trials, Regulatory Affairs, HTA Practices

3 Education Partners - UCD, TCD, HPRA

1 elearning website: www.patientsinvolved.ie

21 Students from 9 counties - 36 applications

Building a new Irish health research environment

Patient & Public Involvement (PPI)

2014 – PPI Paper - Irish Health Research Forum

2016/17 – PPI Reviewers – Health Research Board

2017 – PPI Funding – €1.2mio - HRB + IRC

2017 – Scientific Advice – Patient Involvement – HPRA

Building a new Irish healthcare environment

2008 - National Strategy for Service User Involvement in Health and Social Services (DoHC & HSE)

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2016 – Values in Action, QID Cultures of Person-centeredness (HSE)

2016 – Mental Health Local Recovery Groups (HSE)

2016 – Privacy Impact Assessment for Individual Health Identifier (eHealth Ireland)

2017 - National Patient Experience Survey - Hospitals (HIQA, HSE, DoH)

2017 - National Clinical Effectiveness Committee – PPI Values (DoH, NCEC)

2017 –Personas for Electronic Health Records (eHealth Ireland)

2017/18 - Patient Narrative Project on Person-centered care (CSPD-HSE, IPPOSI)

EU Clinical Trial Regulation, 2018

Building a new European environment

General Data Protection

Regulation, 2018

Generating patient-based evidence

• Stakeholders take decisions based on evidence, not on (our) anecdotes

• Patient organisations are best-placed to generate patient-relevant data

• Cost-effectiveness is key. Prove that the informed patient is cost-effective…..!

Patient Registries

• Evaluating new treatments in real-world settings (Pharmaco-vigilance)

• Rare Disease Reference Centres of Excellence

Slide courtesy of Abigeal Jackson, CF Registry of Ireland

Umotif, PatientslikeMe, Carenity

Graphically display charts, timelines and various representations of different measures

European Atlas of Access to Myeloma Treatment

Slide courtesy of Jan Geissler, CML Avocates.net

Person centered co-ordinated care

Phase 1

What people in Ireland want to experienceduring their care when they require anumber of health services at one time orover time

Phase 2 + 3

A framework that will hear peoples’ experiences of using more than one health service at a time

11 Focus

Groups

2 Online

Surveys

4 Regional

Workshops

Output: Statements (19) + Definition (1)

Online Survey

+ System

Partnerships

Phase 2

• http://www.hse.ie/yourvoicematters

By end of 2017… By end of 2018…

A ‘tried and tested’ framework

• To hear a high volume of patients’ experiences through the online survey

• To use data to influence service design, delivery and improvement of integrated care

• A qualitative and quantitative evaluation of the proof of concept within the context of the HSE;

Integration into ‘business as usual’

• Framework (incl. resource implications) to be integrated into a ‘business as usual’ model

• Quality and Patient Safety Structures at CHO level will be essential

• QID publication: ‘Quality and Safety Committees; Guidance and resources’

Take home messages

• When someone tells you that patients cannot understand or just do not want to know, just look at the data…..

• Our relationship is fragile, dynamic, uncomfortable, ambitious, and goal-oriented

• Over-interpretation and legal paternalism is a barrier to trusted, effective partnership

• Healthcare Environment is changing….are you?

With thanks to…

• Abigeal Jackson, CF Registry of Ireland

• Jan Geissler, Patvocates

• Avril Daly, Retina International

• David Haerry, EATG

• Francois Houyez, EURORDIS

• Matthew May, EUPATI

• Kaisa Immonen, EPF

• Aine Carroll, HSE

Thank you!

@IPPOSI

www.ipposi.ie

dmitchell@ipposi.ie