Share4Rare toolkit for patient advocacy


EUPATI guidance in industry-led research

In 2016, EUPATI published its guidance for all stakeholders aiming to interact with patients on medicines research and development (R&D) throughout the medicines R&D lifecycle. The guidance covers patient involvements in industry-led medicines research, but most of the principles are applicable to academic research too.  Particular for this guidance is that PI should be in line with existing EU and national legislation covering pharmaceutical industry and interaction with the public. In addition, companies will follow their own internal procedures. The document was also not intended to be “prescriptive and give detailed step-by-step advice’’ and it is built on four essential principles:


Patients’ knowledge and perspectives are unique and essentially contribute to industry-led research and development.


Patients have the same rights to contribute to the medicines R&D process as other stakeholders


Patient contribution in medicines R&D counterbalances against the requirements of the industry.

Capacity building

Patient involvement addresses challenges in involving patients in research and building capacity to work together.

Several aspects regarding PI are commonly described for both the Dutch guidance on Patient involvement in academic research (de Wit et al. 2019) and the Eupati guidance in industry-led research (2016):


EUPATI guidance

Dutch guidance

Phase of involvement

Practical roadmap on patient Involvement in R&D

PI in every phase of the research cycle (Phases)

Role in the project

Defining patient

Patient role

Type of contribution

Defining the interaction

Patient role

Identifying the patient group

Patient identification

Recruitment and Selection

Contracts and agreements

Written agreements

Support (agreements)

Financial compensation



Education and training



*not described but implied

Last modified
01 February 2021
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