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Don’t just talk about patient centricity -
put meaningful patient engagement into
the design of your cancer research!
Jan Geissler
Founder and CEO, Patvocates
Chair, WECAN
Vice President, Leukemia Patient Advocates Foundation
Co-Founder, CML Advocates Network
Ex-Director, EUPATI
Patient involvement in clinical development in practice
Improving Patient Involvement in Medicines Research and Development: A Practical Roadmap. Geissler, Ryll, Leto, Uhlenhopp, Therapeutic Innovation & Regulatory Science (2017),
doi: 10.1177/2168479017706405, and at www.eupati.eu
Setting
research
priorities
Protocol
synopsis
Protocol
design
Trial
Steering
Committee
Information to
participants
Data &
Safety
Monitoring
Committee
Investigator
meetings
Fundraising
for research
Practical
Considerations
Patient
Information
Informed
Consent
Ethics
Review
Study
Reporting
Post-Study
Communication
Regulatory
Affairs
Health
Technology
Assessment
Research Design
and Planning
Research
Priorities
Research Conduct and
Operations
Market Authorization and
Post-approval
High
expertise
in
disease
area
required
Medium
expertise
in
disease
area
required
Patient involvement in clinical development in practice
Improving Patient Involvement in Medicines Research and Development: A Practical Roadmap. Geissler, Ryll, Leto, Uhlenhopp, Therapeutic Innovation & Regulatory Science (2017),
doi: 10.1177/2168479017706405, and at www.eupati.eu
Setting
research
priorities
Protocol
synopsis
Protocol
design
Trial
Steering
Committee
Information to
participants
Data &
Safety
Monitoring
Committee
Investigator
meetings
Fundraising
for research
Practical
Considerations
Patient
Information
Informed
Consent
Ethics
Review
Study
Reporting
Post-Study
Communication
Regulatory
Affairs
Health
Technology
Assessment
Research Design
and Planning
Research
Priorities
Research Conduct and
Operations
Market Authorization and
Post-approval
• gap analysis
• early horizon
scanning
• matching unmet
needs with
research
• defining patient-
relevant added
value and
outcomes
• design
• target population
• relevant endpoints,
• patient-reported
outcomes/QoL measures,
• in-/exclusion criteria
• benefit/risk balance
• ethical issues,
• mobility issues/logistics,
• data protection
• diagnostic procedures
• adherence measures
• protocol
follow up
• improving
access
• adherence
• protocol amendments
• new safety information
• trial design
• recruitment
• challenges,
• opportunities,
• can trigger
amendments
• benefit/risk
• drop-out
issues
• amendments
• MAA evaluation
• EPAR summaries
• package leaflets
• updated safety
communications
• lay summary of
results
• contribution to publications
• dissemination of research results
to patient community /
professionals
• summary of interim
results
• dissemination to
patient community
• content
• visual design
• readability
• language
High
expertise
in
disease
area
required
Medium
expertise
in
disease
area
required
• content
• visual design
• readability
• language
• dissemination
• contractual issues
• travel expenses
• support for family members
• mobility
• assessment of value
• patient-relevant
outcomes
• patient priorities
Setting
research
priorities
Protocol
synopsis
Protocol
design
Trial
Steering
Committee
Information to
participants
Data &
Safety
Monitoring
Committee
Investigator
meetings
Fundraising
for research
Practical
Considerations
Patient
Information
Informed
Consent
Ethics
Review Study
Reporting
Post-Study
Communication
Regulatory
Affairs
Health
Technology
Assessment
Research Design
and Planning
Research
Priorities
Research Conduct and
Operations
Market Authorization and
Post-approval
Patient involvement in clinical trial design
Improving Patient Involvement in Medicines Research and Development: A Practical Roadmap. Geissler, Ryll, Leto, Uhlenhopp, Therapeutic Innovation & Regulatory Science (2017),
doi: 10.1177/2168479017706405, and at www.eupati.eu
Increase patient relevance, patient value, and
patient-relevant outcomes with input on
• Patient priorities in risk/benefit
• Patient-relevant endpoints
• Choice of QoL/PRO instruments
• Inclusion/exclusion criteria (“real-world”)
• Mobility / logistics
• Drug administration
• Diagnostics (frequency, necessity)
• Ethical aspects (e.g. cross-over)
There are established models and roles of patient
engagement in (clinical) research projects!
Engagement model Patient organization’s / patient expert’s role Impact
Project coordinator,
chair or co-chair
Leads and coordinates the research project Very high
Steering committee
member
Member of the governance board of the research project Very high
Work package leader Coordinates a specific work package in the project High
Research project
member
Full member of the research teams Medium
Patient engagement
hub
Full project member, coordinating all contributions from the wider
patient community
High
Associated project
partner
Partnership agreement with the research project
(but usually no funding)
Small
Advisor / advisory
board member
Providing advice in ethics committee, scientific/project advisory board,
data safety monitoring board, but no governance or leadership role
Small
This guidance & more will shortly be published at https://www.risingtide-foundation.org/clinical-cancer-research/program-/-core-belief
-- talk to RisingTide Foundation or Patvocates, or follow Twitter @Patvocates to hear when it’s out!
Involve the cancer patient
community in the design and
conduct of your cancer
research
Jan Geissler <jan@patvocates.net>
„Patient input“ – from whom?
The term “Patient” is used imprecisely and does not reflect the different types of input and
experience required:
 “Individual Patients and carers”: personal experience of living with a disease.
 “Patient Advocates”: insight and experience of a larger population of patients
 “Patient Organisation Representatives”: the collective views of a patient organisation
 “Patient Experts”: additional technical knowledge in R&D and/or regulatory
EUPATI Guidance for Patient Involvement in Medicines R&D: HTA, Hunter et al, Frontiers in Medicine (2018),
doi: 10.3389/fmed.2018.00231 and at www.eupati.eu/guidances
“Patient Experience Data”:
Cherry-picking a small number of patients
for focus groups provides opinions, but not
systematic community insights on needs and
preferences!

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Don't just talk about patient centricity - put meaningful patient engagement into the design of your cancer research

  • 1. Don’t just talk about patient centricity - put meaningful patient engagement into the design of your cancer research! Jan Geissler Founder and CEO, Patvocates Chair, WECAN Vice President, Leukemia Patient Advocates Foundation Co-Founder, CML Advocates Network Ex-Director, EUPATI
  • 2. Patient involvement in clinical development in practice Improving Patient Involvement in Medicines Research and Development: A Practical Roadmap. Geissler, Ryll, Leto, Uhlenhopp, Therapeutic Innovation & Regulatory Science (2017), doi: 10.1177/2168479017706405, and at www.eupati.eu Setting research priorities Protocol synopsis Protocol design Trial Steering Committee Information to participants Data & Safety Monitoring Committee Investigator meetings Fundraising for research Practical Considerations Patient Information Informed Consent Ethics Review Study Reporting Post-Study Communication Regulatory Affairs Health Technology Assessment Research Design and Planning Research Priorities Research Conduct and Operations Market Authorization and Post-approval High expertise in disease area required Medium expertise in disease area required
  • 3. Patient involvement in clinical development in practice Improving Patient Involvement in Medicines Research and Development: A Practical Roadmap. Geissler, Ryll, Leto, Uhlenhopp, Therapeutic Innovation & Regulatory Science (2017), doi: 10.1177/2168479017706405, and at www.eupati.eu Setting research priorities Protocol synopsis Protocol design Trial Steering Committee Information to participants Data & Safety Monitoring Committee Investigator meetings Fundraising for research Practical Considerations Patient Information Informed Consent Ethics Review Study Reporting Post-Study Communication Regulatory Affairs Health Technology Assessment Research Design and Planning Research Priorities Research Conduct and Operations Market Authorization and Post-approval • gap analysis • early horizon scanning • matching unmet needs with research • defining patient- relevant added value and outcomes • design • target population • relevant endpoints, • patient-reported outcomes/QoL measures, • in-/exclusion criteria • benefit/risk balance • ethical issues, • mobility issues/logistics, • data protection • diagnostic procedures • adherence measures • protocol follow up • improving access • adherence • protocol amendments • new safety information • trial design • recruitment • challenges, • opportunities, • can trigger amendments • benefit/risk • drop-out issues • amendments • MAA evaluation • EPAR summaries • package leaflets • updated safety communications • lay summary of results • contribution to publications • dissemination of research results to patient community / professionals • summary of interim results • dissemination to patient community • content • visual design • readability • language High expertise in disease area required Medium expertise in disease area required • content • visual design • readability • language • dissemination • contractual issues • travel expenses • support for family members • mobility • assessment of value • patient-relevant outcomes • patient priorities
  • 4. Setting research priorities Protocol synopsis Protocol design Trial Steering Committee Information to participants Data & Safety Monitoring Committee Investigator meetings Fundraising for research Practical Considerations Patient Information Informed Consent Ethics Review Study Reporting Post-Study Communication Regulatory Affairs Health Technology Assessment Research Design and Planning Research Priorities Research Conduct and Operations Market Authorization and Post-approval Patient involvement in clinical trial design Improving Patient Involvement in Medicines Research and Development: A Practical Roadmap. Geissler, Ryll, Leto, Uhlenhopp, Therapeutic Innovation & Regulatory Science (2017), doi: 10.1177/2168479017706405, and at www.eupati.eu Increase patient relevance, patient value, and patient-relevant outcomes with input on • Patient priorities in risk/benefit • Patient-relevant endpoints • Choice of QoL/PRO instruments • Inclusion/exclusion criteria (“real-world”) • Mobility / logistics • Drug administration • Diagnostics (frequency, necessity) • Ethical aspects (e.g. cross-over)
  • 5. There are established models and roles of patient engagement in (clinical) research projects! Engagement model Patient organization’s / patient expert’s role Impact Project coordinator, chair or co-chair Leads and coordinates the research project Very high Steering committee member Member of the governance board of the research project Very high Work package leader Coordinates a specific work package in the project High Research project member Full member of the research teams Medium Patient engagement hub Full project member, coordinating all contributions from the wider patient community High Associated project partner Partnership agreement with the research project (but usually no funding) Small Advisor / advisory board member Providing advice in ethics committee, scientific/project advisory board, data safety monitoring board, but no governance or leadership role Small This guidance & more will shortly be published at https://www.risingtide-foundation.org/clinical-cancer-research/program-/-core-belief -- talk to RisingTide Foundation or Patvocates, or follow Twitter @Patvocates to hear when it’s out!
  • 6. Involve the cancer patient community in the design and conduct of your cancer research Jan Geissler <jan@patvocates.net>
  • 7. „Patient input“ – from whom? The term “Patient” is used imprecisely and does not reflect the different types of input and experience required:  “Individual Patients and carers”: personal experience of living with a disease.  “Patient Advocates”: insight and experience of a larger population of patients  “Patient Organisation Representatives”: the collective views of a patient organisation  “Patient Experts”: additional technical knowledge in R&D and/or regulatory EUPATI Guidance for Patient Involvement in Medicines R&D: HTA, Hunter et al, Frontiers in Medicine (2018), doi: 10.3389/fmed.2018.00231 and at www.eupati.eu/guidances “Patient Experience Data”: Cherry-picking a small number of patients for focus groups provides opinions, but not systematic community insights on needs and preferences!