Enhancement of the EUPATI industry guidance was necessary as patient engagement activities continue to evolve, explain GSK’s Kay Warner, Wolf R See of Bayer, and Ingrid Klingmann of EFGCP

When the EUPATI Guidance for Patient Involvement in Medicines Research and Development (R&D); Guidance for Pharmaceutical Industry-Led Medicines R&D was first published, it was groundbreaking in its endeavours to facilitate the integration of patient involvement across the entire process of medicines research and development. It quickly became the “bible” for interactions between industry and patients as it provided a consistent framework for patient engagement across Europe.

The co-lead contributors on this PARADIGM tool explain that during the project it became evident that further expansion of specific sections of the guidance would be required to build on the previous guidance and increase usability.  

“The original guidance published in Frontiers in 2018 was never intended to be a ‘cookbook’ with step-by-step instructions on what to consider. However, during the PARADIGM project it became clear that two specific sections of the original guidance required further emphasis to provide more detail and recommendations to support individuals responsible for coordinating and planning patient engagement activities,” they say.

The two specific sections include suggested working practices and events and hospitality. The considerations for events and hospitality enhanced guidance provides information on the level of attention needed when arranging patient engagement activities to ensure patients can be sure all the important aspects of the activity have been covered, find optimal conditions and feel comfortable. Meanwhile, the working practices enhanced guidance covers how engagement could be defined with specific actions and to describe what should happen during pre-engagement planning and discussions to ensure mutually beneficial interactions with adequate preparation. The enhanced guidance documents produced within PARADIGM are practical tools which may be used during the planning process.

The group say the enhanced guidance has wide applicability: “Whilst the original EUPATI guidance documents specifically target individuals working for pharmaceutical companies, there is no reason why any individual responsible for coordinating patient engagement activities could not use both these tools for suggested working practices and considerations regarding events and hospitality.  They are written for general application across all different scenarios and aim to be simple to follow by all stakeholders involved.  The only limitations are: advice given is not intended to be exhaustive or applicable at all times; judgement is needed to decide whether or not a recommendation can, should or must be followed.”

Following initial discussion during a break-out session at the PARADIGM workshop in March 2019, an authoring group was formed that was balanced in terms of stakeholder representation and expertise. Discussions were led by the three original guidance authors and an analysis determined that focus should be given to the areas of suggested working practices as well as events and hospitality.

The authoring group met routinely until November 2019 to agree on content and relevant reference materials, and the outcome was the first draft of both enhanced guidance documents. In March 2020 a further draft of the enhanced guidance documents was submitted for consultation within the PARADIGM consortium and the PARADIGM International Liaison Group. In June 2020 the two enhanced guidance documents were submitted to external consultation and discussed during the Patient Engagement Open Forum session on July 9th. The group says all feedback received throughout the consultation was addressed and consolidated.  

Warner, See, and Klingmann note that the strength of PARADIGM lies in the collaboration between all stakeholders in patient engagement and the ability to bring together leading coalitions in this field, EUPATI and PFMD. “The constitution of the working group ensured that the diversities of views, perspectives and needs were taken into account. Of course, the inclusivity of the different perspectives was sought, in order to capture best the insights from the wider patient community involved in PARADIGM,” they say.

As expected, challenges presented themselves: the level of granularity to be aimed for required some discussion to ensure the tools developed were “usable and not overly burdensome”. 

“Accommodating all requests from different parties would have gone beyond the scope and intent to make these tools suitable for ALL individuals/organisations planning patient engagement activities,” the co-leaders emphasise. A good compromise was found, making it clear that everyone should be cognisant of the fact that an “ideal” situation would be hard to achieve under all circumstances and an “optimal” situation should be aimed for, even if requiring a compromise.

The concept of usability was paramount, and the two checklists have been designed as practical tools which may be used during pre-engagement planning of patient engagement activities.  

The suggested working practices checklist defines specific actions that may be appropriate to the activity and can aid discussions to ensure mutually beneficial interactions with adequate preparation.  Organisers can use the right-hand column to include comments addressing considerations such as: “What is the activity?”, “Who/what will it affect?”, “What impact will it have?”, “What is the benefit to the patient/community in participating?” plus self-assess the quality of their preparedness and identify areas for improvement.

Long-term, the group would hope to see more case studies released which can demonstrate how these tools have helped organisers and individuals responsible for coordinating and planning patient engagement activities. “Equally, over time we would like to witness an increase in positive feedback from patients about their experience in patient engagement activities and attending events targeted for them.”

The group says that the tool complements the remainder of those found within the PARADIGM Patient Engagement Toolbox: “In conjunction with the other tools, it aims to make patient engagement easier for all.”