OBJECTIVES: We aimed to evaluate, summarize and provide generalisable case-studies on the impact and value of ‘patient engagement’ (PE) across the asset life cycle of a pharmaceutical. Our objective was to synthesize this information and produce a readily available resource which can be easily understood by all stakeholders.

METHODS: We conducted a scoping search of the academic and grey literature for existing value frameworks and impact assessments of PE for pharmaceuticals. We used 'pearl growing' methods to identify the literature on the topic. Following review, we appraised and pooled the domains from the available frameworks. We conceptualised our own product life cycle framework with a series of core stages and sub-stages where impact could occur. For each stage, we identified published case-studies where we hypothesized that PE could have had a significant and positive impact, if it had been adopted.

RESULTS: We identified a number of relevant frameworks but many struggled to link impact to real-world case-studies potentially limiting their utility. Across the pharmaceutical life cycle, we conceptualised 4 core stages and 12 sub-stages, to which we mapped our case studies. We found that PE could have an important impact on initial product ideation, the efficiency of clinical trial design, the recruitment and retention of trial participants, the appropriateness of patient outcome measures and the transparency of the HTA process. To patients, we identified that benefits and impact could occur due to increased acceptability, adherence and trust in the final product.

CONCLUSIONS: PE has an important role to play but articulating impact can often be challenging with a variety of different measures available. We take a novel approach to identifying impact by highlighting case-studies across the life-cycle.