Leader of the PARADIGM consortium Mathieu Boudes from the European Patients’ Forum (EPF) and Senior Director, Patient Engagement at GlaxoSmithKline, Kay Warner outline the genesis of the PARADIGM tool they led the co-creation of: “Recommendations on how to find the right match for the right patient engagement activity”

Each tool in the PARADIGM Patient Engagement Toolbox endeavours to address an unmet need in patient engagement activities, and offer practical assistance to those committed to meaningful patient engagement throughout the entire drug development process.

During an early analysis of existing practices and processes of patient engagement (PE) within the context of the PARADIGM project, a clear gap was identified which related to a description of the steps followed to identify patient representatives between the engaging partners. 

“Generally limited documentation exists on how patients and their representatives are selected prior to an engagement activity,” explains Warner. Warner and Boudes note that this may be because co-design of selection criteria with the patient community is still evolving and is not yet standard practice, and they also observe that this task is typically managed internally within individual organisations, with published case studies of patient engagement not currently providing that information. Furthermore, the task may be outsourced by the pharmaceutical industry to various vendors providing patient engagement services. 

The need for the tool was obvious: “The recommendations on how to find the right match for the right patient engagement activity aims to provide guidance on the elements associated with identifying patients and their representatives to partner in patient engagement activities,” they explain.

A working group was swiftly created, with representation from all relevant stakeholders. One of the first tasks was to establish key principles. These included: 

  • To meaningfully conduct a patient engagement activity, the right matches (understood as the most suitable patients and/or their representatives) need to be identified.
  • The patient organisations – where they exist – are the first and key point of contact to co-create the engagement project, to avoid purely one-off activities and to start or consolidate efforts to build trust and collaboration with the patient community.
  • Patient organisations are key partners in the definition of the competencies, skills and behaviours of the patients and their representatives.
  • A landscape analysis of the patient community helps to identify the most suitable partners to co-deliver a patient engagement activity. 
  • The table of competencies that sets out the competencies of patients and their representatives should be understood as a way to identify the best matches for a specific patient engagement activity. It could also be used as a self-assessment tool for patients and for patient organisations to assess the capabilities within their own organisations. 

The resulting tool offers clearly defined guidance for each step of a patient engagement activity:

  • Step 1: Outline the patient engagement activity on shared purpose (scope, time, human and financial resources) 
  • Step 2: Identify the right partner(s) – such as patient organisation(s) – to co-create the patient engagement activity
  • Step 3: Co-define the competencies for the patient engagement activity
  • Step 4: Identification of patients or their representatives that match the needed competencies for the activity

Within this working group and the associated PARADIGM workstreams, numerous steps have been taken to ensure the recommendations received a full review and, as with all other tools, have undergone several rounds of consultation. 

A hallmark of the PARADIGM project is its wide range of active stakeholders. According to Boudes and Warner, patient engagement in medicines development is a matter for all stakeholders, therefore, the constitution of the working group tasked with developing this particular tool ensured that the diversities of views, perspectives and needs of all were taken into account. They also sought to involve EUPATI by adapting the competency table, which is a central piece of the recommendations. 

“The inclusivity of the different perspectives should be sought, in order to capture best the insights from the patient community. The engaging partner and the patient organisation(s) should work together to identify suitable matches, and ensure that there is no discrimination between patients populations, as it is clear that no patient can be discriminated against for reasons of health literacy nor lack of training and that processes should always be adapted to the patients’ capacities and needs to ensure meaningful involvement,” they state.

It is envisioned that the tool’s recommendations will make it easier – and quicker – to identify the right matches for the right patient engagement activity in medicines development, especially when initiated by pharmaceutical and biotech companies, thus meeting the need as identified in the original gap analysis. The recommendations may see more widespread use, however, Boudes and Warner note.

“These recommendations can also be used by other medicine developers for patient engagement activities. Long-term we would hope to see more case studies released which can demonstrate how these recommendations have helped stakeholders achieve adequate and appropriate representation of patients in patient engagement activities.”