Co-development in Research: the role of patients and community experts

 

By members of EU-PEARL Patient Advisory Group (PAG) Claas Röhl,  Livia Alimena and Fiona Greenhalgh, and Juan Espinosa, member of the Expert Advisory Group (EAG).

Patient and community engagement in R&D is essential to understand the needs of patients and tailor clinical trials accordingly. While patient engagement is on the rise, we still see a lot of tokenism and have to make sure that patient involvement is more than a term that sounds good in a grant application. Patient engagement must be part of the culture in any R&D process, and there are many encouraging experiences that inspire EU PEARL to ensure patient engagement is integral to the project.

 

The importance of collaboration

Two years into the project, we already have some insight about the possibilities that patient and community engagement can provide to a complex task, such as the development of integrated research platforms. Engagement is more fruitful as a collaborative interaction rather than a mere validation process. For example, after reviewing the first versions of the master protocol template (MPT), TB community advisors suggested a structured approach to community engagement where the MPT regulates where, when and how patients and community will be consulted to make sure that all phases of implementation are covered. Patient and community involvement has shown to speed up regulatory approval and can increase acceptability of participation for individual patients.

Patient and community involvement has shown to speed up regulatory approval and can increase acceptability of participation for individual patients.

Key challenges to patient engagement

Communication is a key challenge in any multi-stakeholder project. It is important to understand the difference between patients and patient representatives. Patients and caregivers can be involved through focus groups, surveys, etc. It needs to be clearly understood when, how and with what type of questions to reach out to patients during the life cycle of EU PEARL. Patient representatives of European patient organisations have the necessary insights to advise and support the outreach to the European populations represented in EU PEARL, for example. The patient representatives and trained patient experts who are involved as associate partners or part of the patient advisory boards need to be involved in all discussions in the different work packages. Otherwise, the patient voice is not well represented in crucial decisions. Discontinuity of patient engagement in any developments in patient centric research projects such as EU PEARL, risks the goal of being the patient centric projects they are set out to be.

It needs to be clearly understood when, how and with what type of questions to reach out to patients during the life cycle of EU PEARL.

Recommended resources on patient engagement

There are many available resources for all types of stakeholders that may help overcome the barriers to patient and community engagement. In 2010 the NIH Director’s Council of Public Representatives (COPR) published 5 core principles for community engagement framework (Ahmed and Palermo, AmJ Public Health. 2010). More recently, two IMI projects: Patients Active in Research and Dialogues for an Improved Generation of Medicines (PARADIGM) and European Patients’ Academy on Therapeutic Innovation (EUPATI), developed guidance documents and toolkits that may help developing Community Advisory Boards and Patient Engagement in pharmaceutical industry-led medicines R&D.

There are many available resources for all types of stakeholders that may help overcome the barriers to patient and community engagement.

Looking forward

Engaging with patients and community requires mutual respect, trust, transparency, and every now and then, patience. Needless to say, it also needs adequate training and funding. Even with all its challenges, patient and community engagement is an opportunity to improve the quality and meaningfulness of research.

 

Claas Röhl is Member of the IMI Scientific Committee. President NF Kinder. President EUPATI Austria.

Juan Espinosa is a Researcher at Global Health and Tropical Diseases department  (Tuberculosis Unit) at Hospital Universitari Vall d’Hebron (Barcelona).

Livia Alimena is the European Office Director for the Global Liver Institute.

Fiona Greenhalgh is Project and Membership Officer at EATG.

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