Elisa Ferrer of EURORDIS and Karina Huberman of the European Aids Treatment Group (EATG) explain why they went back to basics to devise a tool outlining recommendations on the required capabilities for patient engagement 

While there is an increasing trend to engage patients across the lifecycle of medicines, it has not yet become standard practice for many different reasons. One goal of the PARADIGM project was to identify the barriers preventing stakeholders from achieving meaningful patient engagement (PE).

Defining the organisational capabilities to plan, implement and evaluate PE activities is essential to set up the framework to operationalise PE within organisations, say the working group within PARADIGM tasked with addressing this issue.

According to Ferrer and Huberman, although there is often a willingness in stakeholder organisations when it comes to patient engagement, this is not always matched by their capabilities. Staff involved in PE activities also require certain competencies, namely a combination of knowledge, skills and behaviours, in order to perform their job effectively.

“Organisations should have in place processes to define how things are done and tools and systems to help carry out the above-mentioned phases of patient engagement,” they say.

The need for standardised recommendations on the required capabilities for patient engagement was clear. Initially, the working group tasked with developing this tool focused on defining the individual capability framework but were soon inspired by the concept of business capabilities. 

“Since PE in medicines development is not a one-to-one activity but involves different stakeholder groups coming together through their respective organisations, we wanted to identify what is needed at the organisational level both in terms of human competencies and infrastructure – processes, tools and systems and organisational structure,” explain Ferrer and Huberman. Relevant stakeholder organisations include those involved in the development of medicines, including industry and patient organisations, academia, regulatory authorities, HTA bodies and payers.

The group agreed that any basic capability model should contain these four elements and also be adaptable, as PE is in continuous evolution, and transferable, meaning that there should be lateral support and knowledge exchange between the two organisations that engage in the process. They decided not to focus on the specific competencies of the patient participants in any particular PE activity.

Yet this was a huge volume of work. The authoring group was divided further into smaller sub-groups that undertook the writing of the different sections; importantly, such groups were balanced in terms of stakeholder representation and were also asked to reach out to missing stakeholders if needed. 

“We were also able to include specific considerations for engaging potentially vulnerable populations thanks to the experience of two consortium partners that represented the views of children and young patients and those of patients living with dementia,” explain Ferrer and Huberman. The authoring group also reached out to experts within their respective constituencies to provide input for the more specialised sections such as “Legal agreements and managing confidentiality” or “Managing competing interests”.

While the premise was straightforward, Ferrer and Huberman say a recurring challenge was to provide the right depth and length in the contents while ensuring the usability of the tool. “We wanted to provide as much information as possible regarding a topic that has not been well explored in the literature, while also ensuring a hands-on approach for those involved.” 

The resulting framework thus considers the organisational capabilities of all stakeholders involved in PE activities, as the process of engagement occurs through a collaborative partnership between two organisations. Ferrer and Huberman say this tool also highlights the key role of patient engagement functions that may act as a single point of contact both internally and externally hence initiating, facilitating and overseeing the engagement process. They note that the organisational structure of each organisation will determine whether PE expertise should be focused within one function or spread across different roles/functions.

As a crucial element in the PARADIGM Patient Engagement Toolbox, this tool aims to help stakeholder organisations to analyse their own organisations’ capabilities and further expand them for optimal PE. The working group say it will be of immense practical help to organisations, for example, in helping to plan for the necessary resources when conducting PE activities (e.g. adapting processes to patients’ condition-specific needs), as well as defining which organisational functions, beyond PE functions, should have the required competencies (e.g. legal department). This tool can help organisations to identify which type of internal capacity should be built at a given moment, not only in terms of knowledge and skills but also which type of required process and instruments.

This tool covers a broad range of topics relevant for PE in medicines development that have been expanded in other PARADIGM tools. As an example, the capabilities required to reach and interact with patient organisations complement the recommendations on how to identify the right match for patient engagement activities. 

Both Ferrer and Huberman see the tool as being of immense value to organisations hoping to begin a PE journey or those seeking to enhance and embed it within the company ethos.

“Having PE leadership within organisations driving the necessary culture and organisational changes is essential for the long-term sustainability of PE practices,” they conclude.