CRCI Clinical Trials Day 2017 - Dr Derick Mitchell
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This presentation was delivered at a HRB-CRCI event in the Mansion House on May 15th 2017 to celebrate International Clinical Trials Day 2017
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CRCI Clinical Trials Day 2017 - Dr Derick Mitchell
- 1. PATIENTS – SCIENCE – INDUSTRY May 15th, 2017 Derick Mitchell, PhD
- 2. IPPOSI? Who?IPPOSI A patient-led organisation that works with patients, government, industry, & science to put patients at the heart of health innovation
- 3. Our Priorities 20 Actively advocate for improved + equitable patient access to Health Innovation Promote meaningful patient involvement in Health Research and Policy
- 5. Roles change as a result of EUPATI course - creating patient leaders Role 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.
- 6. Practical “Roadmap” on patient involvement in 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 CommitteePractical 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) Fundraising for research Ethics Review
- 7. Building a new Irish healthcare environment 2016 – Mental Health Local Recovery Groups (HSE) 2016 - Patient Narrative Project on Person- centered care (CSPD-HSE, IPPOSI) 2017 - National Patient Experience Survey in Hospitals (HIQA, HSE, DoH) 2017 - National Clinical Effectiveness Committee – PPI Values (DoH, NCEC) 2017 –Personas for Electronic Health Records (eHealth Ireland)
- 8. Building a new Irish health research environment 2014 - PPI paper - Irish Health Research Forum 2016/17 - PPI reviewers - HRB 2017 - PPI Ignite Funding – HRB + IRC 2017 – Scientific Advice – Patient Involvement – HPRA Health Information & Patient Safety Bill? Human Tissue Bill??
- 9. EU Clinical Trial Regulation, 2018 Building a new European environment Research exemption Legitimate interests Consent General Data Protection Regulation, 2018
- 10. What are we doing right now? Friday June 9th, Gibson Hotel, Dublin Data Protection & Dynamic Consent IPPOSI – CRCI Working Group on PPI
- 11. Irish Patient Education Programme • Sept 2017- Feb 2018 • 3 modules • 20 places for patient advocates
Editor's Notes
- A patient-led platform that provides a structured way of facilitating interaction between patients, government, industry, science and academia to put patients at the heart of policy and medicines development. In pursuit of this we hold workshops, discussion groups, training days and conferences on policy, legislation and regulation around the development of new medicines, products, devices and diagnostics for unmet medical needs.
- The different levels in which Patient Organisations and patient representatives can get involved in the clinical trial process These are examples of points in time when patient insights and engagement would be sought by multiple stakeholders This is to demonstrate patient involvement is reality and is in practice, not some funky new idea that may be done in the future!
- The Clinical Strategy & Programmes Division of the HSE initiated the Patient Narrative Project to partner with users of healthcare services in the design and delivery of these services. The Patient Narrative Project is a three phase project to progress to partnership working listened to the experiences of people who have had to use multiple health services over time or at one time and through the words of the service users and caregivers developed a set of statements that clearly articulate what users of the Irish health service expect from services and staff. In addition a definition of person-centred co-ordinated care that is written not just for the experts, but for patients, people, families and carers The goal is that the descriptors + definition of what good care and support that is centred around the needs and preferences of the service user/patient looks and feels like for people will be adopted nationally. They will be used to guide policy, strategy and design, and act as a guide to what teams at local levels should be aiming to achieve practically, in their efforts to integrate services around patient, family and carer needs. There are three themes of descriptors: ‘Care for me’ focused on the direct relational experience with healthcare professionals. ‘Care I am confident in’ refers to the actual experience of care in terms of skills, quality, accountability and continuity of care. ‘Care in my journey through healthcare’ represents care that is holistic, accessible at a time needed and takes account of the world of the person and their carer beyond what was traditionally considered health care, but where health has an impact (e.g. education, working life)
- Health services in Ireland are including patient voices in decision making to a greater extent now than ever before. The HSE’s National Strategy for Service User Involvement 2008-2013, the National Patients Forum, the National Patient Experience Survey and the IPPOSI-led Patient Narrative project are examples. Furthermore, the Department of Health is working with IPPOSI and other relevant patient-led organisations in areas such as rare diseases, dementia and others. Training required to get the expertise required to contribute to research & development projects