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PARADIGM is a public–private partnership and was co-led by the European Patients’ Forum and the European Federation of Pharmaceutical Industries and Associations (EFPIA). PARADIGM’s mission was to contribute to a sustainable framework that enables meaningful patient engagement (PE) and demonstrates ‘return on engagement’ for all stakeholders.

There is increasing consensus among stakeholders that patient engagement at different points of the medicines lifecycle is critical to fostering needs-oriented innovative therapeutic solutions, and delivering better health outcomes for patients.

Despite such development, patients continue to be on the side lines in medicines development. While there are many initiatives emerging to involve and engage with patients, inconsistency and fragmentation remain the norm. For key stakeholders, such as researchers, bio-pharmaceutical companies, regulatory authorities, Health Technology Assessment (HTA) bodies, regulators, and patient organisations, pertinent and basic issues across all groups are: who should be involved, how and when.

This project aimed to address these issues by delivering:

  • Tools and practices; A set of tools and practices, that build upon, and will align with, existing platforms such as EUPATI and PFMD, in order to support mainstreaming the integration of patient perspectives and experiences in medicine development while enhancing mutual trust among the different stakeholders in the patient engagement process.
  • Metrics for impact; Develop agreed patient engagement metrics with validated tools to increase evidence demonstrating the impact of patient engagement practices.

The consortium was organised in seven distinct Work Packages which each delivered specific outputs (see here). All work packages developed their respective outputs in co-creation with the partners in the specific work package (a mix of representatives of pharmaceutical companies, HTA bodies, regulators and patient organisations) and in consultation with the broader field. 

Athena’s role
The researchers at the Athena Institute co-led the work on the development of metrics for monitoring and evaluation of patient engagement. We aimed to stimulate reflexivity among the partners while at the same time integrating a reflexive approach into the monitoring and evaluation tool itself.

In addition, the researchers contributed to a needs assessment among stakeholders in the medicine development field. 

Lessons and outcomes
The co-created recommendations tools and relevant background information can be found in the toolbox.

The Patient Engagement Monitoring and Evaluation Framework, with metrics, was created to help partnerships between patients and/or patient organisations, bio-pharmaceutical companies, regulators and health technology assessment bodies to self-evaluate the progress and impacts of patient engagement in the medicines development lifecycle. This tool:

  • facilitates conversations between stakeholders about the objectives of engagement and meaningful metrics.
  • supports learning to facilitate meaningful patient engagement
  • helps people to understand the pathway to impact of patient engagement
  • can be used to assess the value of engagement for all stakeholders

The tool includes six evaluation components, with 87 possible metrics and 15 context factors. The tool was tested by 24 patient engagement initiatives. There is no ‘one size fits all’ set of metrics appropriate for every initiative or organisation. Therefore, the tool allows users to select metrics to develop a tailored set that aligns with their specific objectives and provides meaningful information in their context.

Athena has received an NWO implementation grant to further disseminate the results and the toolbox. The monitoring and evaluation toolbox as developed by Athena and partners has been taken up by PFMD to be implemented in medicines development.

Patient Engagement Monitoring & Evaluation Framework with metrics

At the Patient Engagement Open Forum 2020, the researchers at the Athena Institute presented the framework. Check out the video to learn more about how the tool can be used.


Project details