Existing codes of practice for patient involvement with various stakeholders do not comprehensively cover the full scope of research and development (R&D). The European Medicines Agency (EMA) has developed a comprehensive framework of interaction with patients and consumer organisations since 2006.
The European Patients’ Academy (EUPATI) guidance documents aim to support the integration of patient involvement across the entire process of medicines research and development with regulatory agencies, health technology assessment (HTA) bodies, ethics committees and the pharmaceutical industry.
Users may deviate from guidance according to specific circumstances, national legislation or the unique needs of each interaction. The guidance documents should be adapted for individual requirements using best professional judgment. You can read the editorial of the guidance here.
EUPATI has published four Guidance Documents on patient involvement in R&D covering ethics committees, health technology assessment bodies, regulatory processes and pharmaceutical industry-led medicines R&D. Each guidance document recommends working methods and processes and suggests specific activities and areas for patient involvement.
Each guidance suggests key areas with opportunities for patient involvement. All guidance documents should be periodically reviewed and revised to reflect evolution and legislation.
The EUPATI Guidance Document in this article aims at providing recommendations for ground rules and proposals for the integration of patient involvement across the entire process of medicines R&D in the pharmaceutical industry and outlines specific activities where patients can be involved and influence future medicines research and development.
This guidance includes a set of introductory “overarching principles” applicable throughout the medicines research and development process; the guidance disclaimer; the scope of the guidance; an explanation of the definition of the term “patient” adopted by EUPATI; the rationale for developing the guidance; background information about patient involvement in HTA in Europe; and the ultimate objectives of the guidance. These sections are followed by the recommendations (suggested working practices and patient involvement activities).
The EUPATI guidance in this article covers patient involvement in the regulatory field. It is primarily aimed at regulatory authorities wishing to interact with patients or their organizations in their activities but should also be considered by patients/patient organizations planning to collaborate with regulatory authorities.
This guidance has been developed by the European Patient Academy on Therapeutic Innovation (EUPATI) for all stakeholders in medicines development involved in the ethical review of clinical research projects, with special emphasis on members of research ethics committees and patients/carers or patient representatives providing patient input.