Improving the multi-stakeholder framework for patient engagement (PE) was the goal of the final session of the PE Open Forum 2019

Hosted by Ingrid Klingmann of EFGCP, Karina Huberman and Giorgio Barbareschi of EATG, the final break-out session of the Open Forum aimed to raise awareness regarding relevant materials already under development and to foster collaboration for future co-creation of the next generation of patient engagement tools. 

Based on the collective expertise in the PARADIGM consortium obvious gaps in the patient engagement governance infrastructure working teams had been established to draft guidance documents:  Community Advisory Boards, Conflict of Interest issues and a Code of Conduct for patient engagement. Work to enhance the EUPATI Guidance for Patient Involvement in Industry-led Medicines R&D, published in Frontiers of Medicine in October 2018 also been already initiated and was presented. 

A session the previous day had sought to prioritise identified gaps in the PE framework and these were then discussed in a breakout session. 

In a break-out session the previous day, the key gaps in the patient engagement framework identified in a comprehensive research project by another Work Package, were prioritised by the participants, taking into account their urgency for filling.  4 key topics from that list were chosen to be further discussed and elaborated in this last break-out session.  In a facilitated discussion, representatives from patient organisations, pharmaceutical industry, academia, regulatory authorities and other stakeholder groups shared their own experiences concerning the respective gap and worked out a recommended format and important content elements to aid in developing a new set of PE tools. The appropriateness and relevance of the prospective tools was also teased out.

The topics for the four roundtable discussions were:

1) Criteria for selection of patients

2) Communication regarding outcomes and processes and lack of reporting/dissemination

3) Formation of a long-term partnership

4) Creation of a Patient Engagement “Starter Kit”

Criteria for selection of patients

In regard to the need of a clear description of the criteria to identify patient representatives for the respective topics of collaboration, the participants suggested the creation of a matchmaking platform run by the patient community, where they can network and trace opportunities for engaging in relevant activities. The platform should be inclusive and accessible, offering space and information to allocate patients appropriately, according to their skills, capacities and interests. 

Communication regarding outcomes and processes and lack of reporting/dissemination

A communication and dissemination strategy should be developed from the beginning of the PE activity. The strategy should include the audience, contents and the where and when, and it should consider all stakeholders. It should be addressed both to internal and external audiences, as well as consider issues of credibility and quality control. Issues to be addressed include barriers set by strict confidentiality clauses, cultural relevance and building the capacities of patients as co-authors.

Formation of a long-term partnership

A pre-requisite for a successful long-term relationship is the preparation of a plan on the engaging partner’s side which defines among others: objectives, expectations on outcomes, the process of defining the patients’ inclusion selection criteria, the concrete tasks and related time requirements, legal and financial conditions for the collaboration, the rules for supervision of the collaboration, as well as reporting and dissemination plan for this PE initiative. Special needs of patient engagement and a long-term relationship in different phases in the life-cycle of medicine should be taken into consideration. 

Creation of a Patient Engagement “Starter’s Kit”

Participants noted that a starter kit should include tools covering all PE interactions throughout different stages of the R&D process. A checklist of what is necessary for setting up PE activities as well as tools and recommendations for diverse stakeholders are key. Inclusiveness and accessibility were raised once again, along with building on existing examples like EUPATI as well as local initiatives.

The participants in the break-out session concluded that the development of the identified tools would be crucial for a future patient engagement framework.