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EDITORIAL
published: 08 November 2018
doi: 10.3389/fmed.2018.00310
Frontiers in Medicine | www.frontiersin.org 1November 2018 | Volume 5 | Article 310
Edited by:
Michel Goldman,
Free University of Brussels, Belgium
Reviewed by:
Scott S. Wagers,
Consultant, Maasmechelen, Belgium
D. J. A. Crommelin,
Utrecht University, Netherlands
*Correspondence:
Per Spindler
pesp@biopeople.ku.dk
Specialty section:
This article was submitted to
Regulatory Science,
a section of the journal
Frontiers in Medicine
Received: 04 October 2018
Accepted: 22 October 2018
Published: 08 November 2018
Citation:
Spindler P and Lima BS (2018)
Editorial: The European Patients
Academy on Therapeutic Innovation
(EUPATI) Guidelines on Patient
Involvement in Research and
Development. Front. Med. 5:310.
doi: 10.3389/fmed.2018.00310
Editorial: The European Patients
Academy on Therapeutic Innovation
(EUPATI) Guidelines on Patient
Involvement in Research and
Development
Per Spindler 1
*and Beatriz S. Lima 2
1Biopeople, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark, 2Instituto de
Investigação do Medicamento (iMed.ULisboa), Lisbon, Portugal
Keywords: EUPATI, european patients academy on therapeutic innovation, patient involvement, patient advocacy,
innovative medicines
Editorial on the Research Topic
The European Patients Academy on Therapeutic Innovation (EUPATI) Guidelines on Patient
Involvement in Research in Development
Our colleagues and we are working toward improving health by speeding up the development of
and patient access to innovative medicines, particularly in areas where there is an unmet medical
or social need. It appears pivotal that key players of health care research collaborate on involving
patients in research, which may hugely benefit the medicines development process: by bringing
their priorities, perspectives, and knowledge about their own diseases to the table, patients can
contribute to developing better treatments. Thus, there is a call for action to trigger a major rethink
of the way patients and the public understand the medicines development process and their own
involvement. There is an additional need to shape and facilitate the ways patients and patient
organizations can be involved to handle the many complex ethical, legal and other issues intrinsic
to the development process.
The European Patients’ Academy on Therapeutic Innovation (EUPATI) was established as part
of the partnership between the European Union and the European pharmaceutical industry, the
so-called Innovative Medicines Initiative (IMI). EUPATI has set up structures to develop and
disseminate accessible, well-structured, comprehensive, scientifically reliable, and user-friendly
educational material for patients on the processes of medicines research and development (R&D).
Like EUPATI, we believe that once armed with a deeper understanding patients, patient experts and
patient advocates will be even more empowered to work effectively with the relevant authorities,
healthcare professionals and industry to influence the medicines development process for the
benefit of patients and society.
Patient organizations, academia, not-for-profit organizations, and pharmaceutical companies
are represented in the EUPATI partnership. Together, through reviews and a process of public
consultation, sets of policies and standards for patient’s involvement in medicines research and
development have been published. Thus, through the collaboration between multiple stakeholder
and interest groups, conflict of interest in presentations and views is managed and controlled
through transparent procedures. We therefore envisage that the guidelines will be used in relevant
stakeholder communities and that they will contribute to the development of internal operating
procedures in organizations and companies.
Spindler and Lima Editorial
FIGURE 1 | Patient involvement in medicines R&D: Patients can meaningfully contribute across the process of medicines R&D. This diagram illustrates the R&D
process that require expertise in the respective disease areas. The guidances for patient involvement covered by EUPATI is the ethical review, the regulatory processes
including regulatory affairs, Health Technology Assessment (HTA) and the industry-led research and development of medicines. ©EUPATI, under a Creative Commons
license CC BY-NC-SA 4.0. Used with permission.
Each of four contemporary fields of patient involvement in
medicines research and development are covered in publications
(Figure 1).
First, Health Technology Assessment (HTA). HTA is to
inform decision making by health care policy makers and is
the basic process that evaluates the use of health technologies
and generally involves a critical review of international evidence
related to clinical effectiveness of the health technology vs. the
best standard of care. The outcome of HTA is recommendations
whether or not a health technology should be used, and
if so, how it is best used and which patients are most
likely to benefit from it. Thus, the patient perspectives on
experiences and preferences in the HTA process are valuable.
The EUPATI Guidance for Patient Involvement in Medicines
Research and Development: Health Technology Assessment
provides recommendations for activities to support patient
involvement in HTA bodies and specific guidance for individual
HTA processes (Hunter et al.). The publication also discusses
the recent progress in, and continuing barriers to, patient
involvement in HTA.
Secondly, the EUPATI guidance for patient involvement
in medicines research and development (R&D); Guidance
for pharmaceutical industry-led medicines R&D covers the
interaction between patients and the pharmaceutical industry
within all functions throughout the medicines R&D lifecycle
in relation to medicines for human use (Warner et al.). This
publication relates to activities both pre-approval and post
marketing, and involving both individuals and groups of patients.
Thirdly, the EUPATI and Patients in Medicines Research
and Development: Guidance for Patient Involvement in Ethical
Review of Clinical Trials gives recommendations for involving
patients in the work of ethics committees (Klingmann et al.). This
publication provides additionally definitions and a presentation
of the broader context of involvement of patients in ethical
evaluations.
Finally and fourthly, the EUPATI and Patients in Medicines
Research and Development: Guidance for Patient Involvement
in Regulatory Processes covers patient involvement in the
regulatory field and draws on the “Framework for interaction
between the European Medicines Agency (EMA) and
Frontiers in Medicine | www.frontiersin.org 2November 2018 | Volume 5 | Article 310
Spindler and Lima Editorial
patients and consumers and their organizations” (Haerry
et al.). It expands on the EMA framework, specifically
including National Competent Authorities (NCAs). It sets
out objectives for patient involvement in medicines regulation
and recommends concrete suggested working practices.
It is primarily aimed at regulatory authorities wishing
to interact with patients or their organizations in their
activities but could also be considered by patients/patient
organizations planning to collaborate with regulatory
authorities.
We are thankful to the team of collaborating organizations
and individuals in EUPATI and IMI for the production of
these sets of guidelines, and we are looking forward to fruitful
follow-on actions aimed at providing accessible medicines
to patients in need. We trust that patients’ involvement is
one of the significant elements of medicines research and
development in the future, and we wish you a pleasant and useful
read.
AUTHOR CONTRIBUTIONS
All authors listed have made a substantial, direct and intellectual
contribution to the work, and approved it for publication.
Conflict of Interest Statement: The authors declare that the research was
conducted in the absence of any commercial or financial relationships that could
be construed as a potential conflict of interest.
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