OBJECTIVES: Patient engagement (PE) in drug development has become routine, but assessing its quality and impact remains elusive. Approaches have been proposed, but no standard framework or metrics exist for gauging PE investments. This project’s objective was to co-create a Novartis PE impact-measurement (PEIM) framework with metrics to benchmark and monitor, internally and externally, PE activity quality, outcomes, and impact.

METHODS: An advisory group of patient representatives and PE experts guided the project, co-creating deliverables with logistical consultancy support. Evidence inputs included: 1. A broad literature/internet search for existing, publicly available documents on PE quality and impact evaluation; 2. Qualitative interviews with internal and external stakeholders, and 3. Structured, iterative, internal cross-functional working groups and external advisory-group working sessions during which evidence was reviewed and a framework and metric drafts were created, discussed, and refined.

RESULTS: The search identified no fit-for-purpose framework or metrics usable “off the shelf,” but a number provided foundational evidence inputs. Qualitative data provided guiding themes (e.g., Clarity in language, definitions; Applications beyond randomized trials; Representativeness and diversity; Structure, process, and outcome metrics; Use of pragmatic and evolving metrics; Varying stakeholder goals; Product lifecycle considerations; etc.). A draft framework and metrics resulted that span the drug development lifecycle.

CONCLUSIONS: The PEIM framework and metrics integrate patient voices into research and development programs and business strategy, ultimately strengthening healthcare systems through tangible short-, intermediate-, and longer-term goals. This offers a starting place for Novartis and other companies to consistently and systematically assess PE activity quality, outcomes, and impact internally and externally. It is Novartis’ intent to make the framework and metrics publicly available for use, testing, and refinement to inform industry benchmarking of PE and enable industry standards to emerge over time.