Potential roles of patient advocates

Some ideas of the roles that patient advocates could play in the medicines development process include:

Setting priorities and cross-cutting issues

  • Contributing to early horizon scanning, target product profile definition, intended research outcomes
  • Ensuring that patients’ needs are considered within the research process
  • Facilitating relationships between key stakeholders in medicines development, e.g. bridge gap between authorities, researchers, payors at the research design stage
  • Acting as advocates to influence research priorities
  • Defining patient-relevant added value (e.g. as measures for HTA after conclusion of research) and engaging on health technology assessment (HTA)

Design and Planning

  • Defining the level of involvement (research subject, info provider, advisor, reviewer, co-researcher or driving force in medicines research & development, according to the Patient Partner project)
  • Involving in research protocol design (e.g. in patient-centric definition of relevant endpoints, inclusion/exclusion criteria / target population, diagnostic procedures and monitoring, patient-reported outcome / quality of life measures, risk/benefit assessment, cross-over, patient safety, ethical issues, mobility issues, data collection methodology, data protection)
  • Fundraising to fund research work
  • Defining, evaluating or revising informed consent procedures and patient information documents (content, visual design, readability and language)

Research conduct and operations

  • Acting as co-researcher or driving force of research (patient-led research)
  • Informing and recruiting potential research participants
    * Improving information to research participants (e.g. in case of protocol amendments, if new safety information becomes available, if research is discontinued)
  • Improving patient access to trials
  • Engaging in managing and retaining research participants, and re-contacting them for follow up purposes
  • Engaging on data monitoring committees e.g. for risk/benefit monitoring, adherence/drop-out issues, amendments to protocol

Dissemination and communication

  • Contributing to publications, supporting creation of lay summaries
  • Engaging on dissemination (strategy, implementation) of research results to patient community and professional communities
  • Supporting patients to take a more active role in their care, including making decisions about research participation
  • Communicating about first-hand patient experiences in research to encourage others to take part

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