ucd pharmtox event on clinical trials
TRANSCRIPT
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PATIENTS – SCIENCE – INDUSTRY
March 6th, 2017
Derick Mitchell, PhD
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Overview
• IPPOSI?
•What do Irish people think about clinical trials?
•What do we mean by patient involvement in trials?
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IPPOSI? Who?IPPOSI
A patient-led organisation that works with patients, government, industry,
& science to put patients at the heart of health innovation
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Priorities
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Actively advocate for improved + equitable patient access to Health Innovation
Promote meaningful patient involvement in Health Research and Policy
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Irish public perception
Irish general public’s attitude towards clinical research
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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
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Public information campaignclinicaltrials.ie
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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
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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Source: Geissler, Ryll, Leto, UhlenhoppEPALCO/EUPATI (2015, unpublished)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
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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
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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
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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!
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EUPATI Toolbox – www.eupati.eu
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EUPATI Toolbox – Content available
Infographics
Articles
Fact sheets
PowerPoints
Videos
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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.
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Everyone is different!
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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
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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
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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
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