Patient Involvement Activities

Ways of contribution

Patient Involvement Activities

The journey from scientific discovery to transformative healthcare solutions thrives on diverse perspectives and collaborative engagement. This section offers a comprehensive overview of the myriad opportunities for patient involvement throughout the research and development lifecycle.

The path to impact

Diverse opportunities in Patient-Centric Research

Explore the various stages where collaboration can bridge gaps, foster understanding, and ultimately shape the future of patient-centred healthcare.

Setting Research Priorities Define research priorities to ensure that development of novel therapies or interventions is focused on areas of patient care that require improvement.

Gap analysis An evaluation and assessment of the current status of therapies/intervention in development for the purpose of identifying the differences between the current state and where patients would like it to be.
Early horizon scanning A systematic outlook to detect early signs of potentially important developments through examination of potential threats and opportunities, with emphasis on new technology and its effects on the issue at hand.
Matching unmet needs with research Evaluations to match the unmet needs of patients/patient communities with available interventions and resources to identify gaps for improvements and further steps in research.
Defining patient-relevant added value and outcomes Insights from patients/patient communites in determining what is of meaningful value and relevant outcomes for patients, to ensure research efforts focus on those.

Protocol synopsis
This includes revision of the protocol design and evaluation of the target population.

Practical considerations
This includes revision of contractual issues, travel expenses, support for family members, mobility.
Protocol design
This includes revision of the following sections: Relevant endpoints, in-/exclusion criteria, diagnostic procedures, patient-reported outcomes/QoL measures, benefit/risk balance, ethical issues, mobility issues/logistics, data protection, adherence measures.
Patient information
This includes revision of content, visual design, readability, language, dissemination.
Informed Consent
This includes revision of content, visual design, readability, language, age suitability.
Ethics Review

Trial Steering Committee
This includes the following tasks: Protocol follow-up, Improving access, Adherence.
Information to trial participants
This includes tasks on protocol amendments and/or new safety information.
Investigator meetings
This includes revision and discussion on trial design, recruitment challenges and opportunities, resulting amendments.
Study Reporting
This includes revision of summary of interim results and/or dissemination of results to the patient community and professionals.
Data analysis and interpretation of result
This includes interpretation of PRO data, ensuring that the analysis takes into account the patients’ lived experiences, including emotional and financial burdens.
Data & Safety Monitoring Committee
This includes revision and discussions on benefit/risk, drop-out issues, amendments.

Regulatory Affairs
- MAA evaluation | Patients evaluate marketing authorisation applications to ensure that patient perspectives are considered in the approval process.
- EPAR summaries | Ensure that summaries of the European public assessment reports are clear and understandable to patients.
- Package leaflets | Review package leaflets to ensure they are written in plain language and provide necessary information in an easily understandable format.
- Updated safety communications | Ensure that new safety information is communicated clearly and effectively to patients.
- Lay summary of results | Provide lay summaries of research results as required by regulatory bodies.
Health Technology Assessment
- Assessment of value | Patients involved in the assessment of the value of new health technologies to ensure that patient-relevant outcomes are considered.
- Patient-relevant outcomes | Ensure that the outcomes measured in HTA are relevant to patients/patient communities.
- Patient priorities | Incorporation of patient priorities into HTA to ensure that the evaluations align with what is considered important for patients.
Post-study communication
- Contribution to publications | Involving patients in the preparation and review of research publications to ensure that findings are communicated accurately and accessibly to the patient community.
- Dissemination of research results to patient community/professionals | Involving patients in the preparation and review of research publications to ensure that findings are communicated accurately and accessibly to the patient community.

Pre-submission
- Orphan Designation
  - Committee for Orphan Medicinal Products (COMP)
- Scientific Advise / Protocol admissions
  - Committee for Human Medicinal Products (CHMP)
  - Scientific Advice Working Party (SAWP)
  - Committee for Advances Therapies (CAT)
- Paediatric Investigation Plan
  - Paediatric Committee (PDCO)
Evaluation
- Marketing Authorization application evaluation
  - CHMP
  - CAT
  - Pharmacovigilance and Risk Assessment Committee (PRAC)
Post-authorisation
- Post-marketing authorisation
  - CHMP
  - PRAC
  - Scientific Advisory Group (SAG)

Community Advisory Board Groups established by patient advocates to discuss the latest developments, challenges and issues related to medical research in their disease area.
Advisory Committee Share patients’ opinions and perspectives, study issues, and develop recommendations in a focused, small group structure.
Ethics Committee Involvement of patient experts in ethics committees to ensure that research is conducted in a manner that respects patients’ rights and dignity.
Guideline committee Develop and implement procedures to ensure that clinical practice guidelines are based on the best available evidence and are produced in ways consistent with internationally accepted best practices.
Patient advocacy committee Represent, promote, and advocate for the interests of the community with regard to policies, laws, regulations and other developments.

Research project partnership
- Review scientific research/project proposals | Ensure it is relevant and meaningful to patients/patient community.
- Letter of intent/support for research initiatives | Provide a letter of intent or support for research initiatives to confirm patient endorsement and alignment with patient needs and priorities.
Peer Review for journal articles
- Review articles to ensure the research is relevant and meaningful to patients.
Fundraising for research
- Evaluate funding proposals to ensure projects are aligned with patient needs and priorities in the specific area.
General lay language content revision
- Revision of general lay language content to ensure that it is clear, accessible, and understandable to a non-expert audience.
- Evidence based advocacy
  - Surveys | Participate in the design and distribution of surveys to ensure they are understandable, result in meaningful outcomes for patients, and respect data protection rules.
  - Patient preference studies | Participate in the design and execution of patient preference studies to ensure they accurately collect data to understand what matters most to patients, and that it is presented in an understandable way for patients.

Are there any activities missing?

Do you need expert patient support for any other task?

Unlocking the power of true
Patient Involvement

Driving Collaboration Between Researchers and Patient Experts

Ways of contribution