Background: Patient engagement (PE) is becoming more customary in medicines development, yet there have been few attempts to assess its value. PARADIGM is an IMI-sponsored initiative to embed sustainable and meaningful PE in medicines development. One output is the creation of a monitoring and evaluation framework, with metrics, to demonstrate impact and enhance learning.

Methods: A consortium of 4 patient groups, 15 bio-pharmaceutical companies and 2 academic groups iteratively created a framework in a multi-phase participatory process which was then piloted by several participants and refined towards the final version.

Results:

The framework guides stakeholders to evaluate their PE activities in the following domains:

• Objectives: what are we trying to achieve? Why is that of value?
• Inputs: what is necessary to make the engagement happen? e.g. time, money, knowledge, data, facilities.
• Process: what happens during the patient engagement activity? e.g. community advisory board, creation or critique of documents
• Learnings and changes: what are the (short term) learnings that might lead to change, or confirm what is planned is appropriate.
• Impact: what impact might the activity have in the longer term? Might be expressed in operational measures (recruitment rate, amendments) or terms of trust, reputation or support for future engagement.

The final framework consists of an interactive tool, hosted on an open-access platform, leading participants through the series of steps to decide what to measure. Sets of suggested metrics are available for each domain. The user can then assess the extent to which objectives were met, and by evaluating each component, demonstrate the value of the PE activity and improve future activities.

Conclusion:

Introducing change into any process is best done when the value of that change is clear. This framework allows participants to define what they value, and assess to what extent an patient engagement activity has contributed.