Patient Engagement for Medicines Development in a nutshell

Framework building methodology

In 2016, PFMD embarked on a journey to co-create a patient engagement guidance and toolkit – that is valid across all phases of medicines lifecycle – to help and support stakeholders to implement more meaningful patient engagement measures and practices.

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The process started with a landscape mapping, literature review and analysis of existing frameworks and toolkits, in order to avoid duplication of work. After the preliminary mapping exercise multi-stakeholder Working Groups were established to formulate a plan of actions, followed by specific Task Forces (TFs) that took on the mission to complete the plan.

The framework building roadmap below provides detailed descriptions for all stages from the beginning to the finalisation of the framework. The current stage in the process is highlighted for clarity.

Progress so far:

Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
Step 7
Step 8

The final Patient Engagement Framework will be a comprehensive package that includes guidance, templates, toolkits, learnings and experiences from existing patient engagement projects through case studies and practical, real-world examples. The package will potentially also include training and support for all stakeholders who are embarking on the patient engagement journey, or are looking for ways to make their existing frameworks more targeted and meaningful. The Patient Engagement Framework will be maintained and updated on a regular basis to accommodate the evolution of the the landscape. The following step by step strategy has been created in order to reach the planned outcome:

Step 1 – Mapping and connecting the existing patient engagement landscape to learn from existing resources and published material (completed with active ongoing review)

The first step involves synergising the current landscape through the SYNaPsE. The initiatives entered in SYNaPsE are analysed, shortlisted based on the maturity of the methodology and categorised according to stage within the medicines lifecycle, geography, type and level of patient engagement. Together with the insights provided by literature reviews, analysis of existing PE frameworks, and the Stakeholder Expectations Matrix, these initiatives form a starting point for construction of the framework.

Step 2 – Co-creation (ongoing)

PFMD members identified key stakeholder representatives to be invited to the Framework building working groups (WGs). WGs were tasked to define the scope of the framework, to identify gaps in the outputs from Step 1 (mapping and connecting), and to create a prioritised action plan to move forward. Operational task forces (TFs) were formed to continue developing and delivering  prioritised action items.

Since the Framework building work stream started in 2016, we’ve held 7 workshops with more than 70 people representing a wide variety of stakeholders (patient organisations, industry, biotech, researchers, regulators, HTA representatives, research hospitals and independent experts)

At some point, the work had reached a point where the PFMD team needed to form a sub-group of Contributors to drive the next steps of the framework. This group, the Framework Building Core Team, has started their work already and are taking part in strategic discussions, creating content, and acting as the first review and validation point of outputs.

Step 3 – Developing the Strawman Framework from the outputs of WGs and TFs priority action items (pending outcomes from the previous step)

This step concerns the creation of the first version of the framework that is ready to pilot. It includes general guidance, detailed instructions and a toolkit to implement a range of patient engagement practices in the different stages of research and development of the medicine lifecycle. The pilot period will be carefully documented for further analysis in the next step.

Step 4 – Creation of  the Patient Engagement Framework (pending outcomes from the previous step)

After the pilot period, all feedback, user experience and learnings will be analysed to identify improvements needed in order to create a practical and useful Patient Engagement Framework with a toolkit for all stakeholders and all stages of medicines development continuum and care journey. The scope of this step will be clarified as the previous step ends.

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