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.
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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 | An outlook to detect early signs of potentially important developments through examination of potential challenges and opportunities, with emphasis on new technology and its effects on the issue at hand.
Matching unmet needs with research | An evaluation 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 design | This includes revision of the following sections: Protocol Synopsis (Design and target population), relevant endpoints, in-/exclusion criteria, diagnostic procedures, patient-reported outcomes/QoL measures, benefit/risk balance, ethical issues, mobility issues/logistics, data protection, adherence measures.
Practical considerations | This includes revision of contractual issues, travel expenses, support for family members, mobility.
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 | Participation in ethical review processes to ensure research is conducted in a manner that respects patient rights and dignity.
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 and retention 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 risk/benefit, drop-out issues, amendments.
Regulatory Affairs
- Package leaflets | Review package leaflets developed by the Marketing Authorisation Holder 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 generated by the Marketing Authorisation Holder is communicated clearly and effectively to patients.
- Lay summary of results | Revision of lay summaries of research results provided by the Marketing Authorisation Holder.
Post-study communication
- Contribution to publications | Involving patients in the preparation and review of research publications to ensure that findings are communicated accurately and clearly to the patient community.
- Dissemination of research results to patient community/professionals | Involving patients in the preparation and review of research dissemination to ensure that research results are disseminated effectively to the patient community and professionals.
Pre-submission
- Orphan Designation | For example, EMA plays a central role in facilitating the development and authorisation of medicines for rare diseases, which are termed ‘orphan medicines’ in the medical world. This may include participation in committees for Orphan Medicinal Products, responsible for recommending orphan designation of medicines for rare diseases.
- Scientific Advise / Protocol admissions | For example, EMA provide medicine developers advice on the most appropriate way to generate robust evidence on a medicine’s benefits and risks. EMA provides scientific advice to support the timely and sound development of high-quality, effective and safe medicines, for the benefit of patients. This may include participation in committees for Human Medicinal Products, Scientific Advice Working Parties and/or Committees for Advanced Therapies.
- Paediatric Investigation Plan | A development plan aimed at ensuring that the necessary data are obtained to support the authorisation of a medicine for children, through studies in children. This may include participation in Paediatric Committees, to support the development of medicines for children in the EU by providing scientific expertise and defining paediatric needs.
Evaluation
- Marketing Authorization Application evaluation | Patients evaluate marketing authorisation applications submitted to the regulatory authorities, to ensure that patient perspectives are considered in the approval process. This may include participation in internal committees and/or Scientific Advisory Groups.
Post-authorisation
- Post-marketing authorisation | For example, EMA provides scientific and regulatory guidance to pharmaceutical companies whose medicinal products have been authorised in Europe. This may include participation in Committees for Human Medicinal Products, Pharmacovigilance and Risk Assessment Committees and/or Scientific Advisory Groups.
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.
Documents for the Public – supporting regulatory Authorities
- Public summaries of Opinion
- EPAR summaries | Ensure that summaries of the European public assessment reports are clear and understandable to patients.
- Package leaflets | Review and reformat leaflets submitted to regulatory authorities, to ensure they are written in plain language and provide necessary information in an easily understandable format.
- Risk Management Plan summaries
- Safety Communications | Ensure that safety information is communicated clearly and effectively to patients.
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/Steering Committee | Multistakeholder group or group of patients to share stakeholders’/patient’s opinions and perspectives, study issues, and develop recommendations in a focused 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 | Co-develop/Contribute to research/project proposals and partner in the approved research, to ensure it is relevant and meaningful to patients/patient community, ensuring meaningful patient involvement in research.
Peer Review for journal articles | Review articles to ensure the research is relevant and meaningful to patients.
Review of funding calls and applications for research | This involves being part of the evaluating board of funding calls to review funding announcement and evaluate proposals.
General lay/plain language content revision and co-creation | Revision and/or co-creation of general lay/plain language content to ensure that it is clear, simple, and understandable to a non-expert audience.
Surveys | Participate in the design and distribution of surveys to ensure they are understandable, aim meaningful outcomes for patients, and respect data protection policies.
Patient preference studies | Participate in designing and carrying out patient preference studies to ensure it accurately collects data to understand what matters most to patients, and that it is presented in an understandable way for patients.
Unlocking the power of true
Patient Involvement
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