OBJECTIVES: Real World Data & Evidence Generation (RWDEG) is needed to supplement data from clinical trial’s and Patient Involvement (PI) in this process is not well defined. This work aims to explore if, when and how Pfizer UK currently involve patients and carers in RWDEG and improvements needed

METHODS: An assessment was conducted (March-Aug 2021) to evaluate Pfizer UK PI in RWDEG via interviews held with internal Pfizer colleagues and external stakeholders, using a set of 9 pre-defined questions. Where PI was happening, examples were collated as case studies. A subsequent survey was sent (December 2021) to all 6 medical therapy area leads to assess if there were changes over time in PI. Results were summarised descriptively, and themes were drawn out from open ended questions analysis

RESULTS: Pfizer colleagues (n=26), patients (n=2), academic researcher (n=1) and Patient Organisation representative (n=1) were interviewed. All Pfizer colleagues recognised the value of PI, 42% had worked directly with patients and 58% that hadn’t, either their job didn’t mandate it (67%) or no opportunity to do so (33%). Follow-up RWEDG survey found 5 (83%) therapy areas were involving patients, but it was still happening <50% of the time. Challenges included, lack of colleague experience, compliance hurdles and clear guidance to ensure meaningful PI. Patients stated, it was important to have an ambassador to keep meaningful PI on everyone’s agenda, ongoing evaluation of feedback to inform process and measuring impact was paramount. Involving patients early in the process, co-designing strategy, and priority setting was seen as key areas by all stakeholders

CONCLUSIONS: These results defined there was a need for a more systematic approach for PI in RWDE generation in industry and frameworks to support implementation. Acting upon this, further work is planned directly with patients and carers to co-create the frameworks and resources to enable meaningful PI