Media portrayal:


Scientific interpretation:

EUPATI guidelines promote patient involvement in medicines research and development

Original article:EUPATI guidance for patient involvement in medicines research and development (R&D); guidance for pharmaceutical industry-led medicines R&D, Frontiers in Medicine: October 9, 2018. 

The takeaway

Until recently, a recognized code of practice for patient involvement in the research and development of new medicines was missing. A European initiative has now set out guidelines which cover the full scope of patient involvement in this process.

Why is it important?

The EUPATI guidelines are designed to aid in the fuller integration of stakeholder input into the pharma R&D process. It is an important move that promotes the voice of patients and puts it at equal standing to that of experts.


It is now widely acknowledged that involving patients in all stages of research and development of new medicines is beneficial and should be promoted. Ongoing interaction between patients and drug companies, regulators, universities, scientists and medical professionals will enhance and benefit the process of developing new effective medicines, through identifying unmet needs, and what really matters for people living with a condition, improve clinical study design and shape better endpoints and outcome measures. However, the European Patients’ Academy on Therapeutic Innovation (EUPATI) identified an important gap: until now, there are no codes of practice to guide this process of integrating patient, and more broadly stakeholder input, into medicines R&D. In addition, a large survey of around 2800 individuals from 84 countries in various pharma roles indicated that pharma is making efforts to listen, but lack of know-how, sticking to a traditional model of pushing a product rather than adopting a novel, patient-centric approach and other barriers stood in the way of greater integration of patient input.

The details

Supported by the Innovative Medicines Initiative (IMI) Joint Undertaking programme, EUPATI comprises 33 organizations with partners from patient organizations, universities, not-for-profit organizations, and drug companies. Over a series of multiple consultations and having reviewed existing documentation, four sets of guidelines have been produced regarding patient involvement throughout different steps of the drug development process for pharmaceutical industry-led medicines R&D, ethics committees, regulatory processes and health technology assessment bodies.

Core principles governing these guidelines that are meant to outline opportunities rather than limit this involvement are:

  1. Relevance: patients have unique, inside knowledge of their condition which constitutes essential evidence.
  2. Fairness: patients have the same rights, knowledge and experience to contribute to the R&D process as other stakeholders.
  3. Equity: involving patients promotes equity by bringing to the fore their diverse needs balanced against industry requirements.
  4. Capacity building: clearly outlined guidance for these processes address the aforementioned barriers to involving patients in medicines R&D directly.

In these guidelines, a number of definitions are set out, as are ways of promoting the aforementioned values throughout every step of the process, from the earliest identification of unmet needs and setting of research priorities, to the final regulatory post-approval processes and dissemination of findings. The guidelines attempt to map out how this interaction can be optimized, respecting the rights and investment of all parties involved.

Next steps

This philosophy underpins Parkinson’s Movement and the current webpages. It is hoped that these guidelines will be broadly adopted.

Related work

Original article:EUPATI guidance for patient involvement in medicines research and development (R&D); guidance for pharmaceutical industry-led medicines R&D, Frontiers in Medicine: October 9, 2018. Warner K, See W, Haerry D, Klingmann I, Hunter A, May M. 


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