OBJECTIVES: Involving patients and carers in RWDEG strategy is essential for the pharmaceutical industry to conduct patient centric research. More recently, clinical trial researchers have become increasingly aware of how important it is to not only include measures of patient reported outcomes but also involve patients in the design and planning of trials, with work having been done to understand behavioural drivers and barriers for involvement.

METHODS: Patient and carer involvement (PI) in RWEDG is in a much more nascent phase. Despite PI being regarded as an opportunity to build trust and collaboration, examples of involvement systematically happening in RWDEG are generally limited to phase 4, market research or patient preference studies. Making sure the patients and carers involved in RWDEG are representative of the wider population and includes people that are harder to reach, experience health inequality or have lower health literacy is essential in making sure data and the evidence generated aligns with what is important to all patients.

RESULTS: Drawing on established frameworks such as the Patient Focused Medicines Development quality guidance we will conduct a series of co-creation workshops and focus groups with patients and carers, which can be validated through a large scale survey in the broader UK population to develop a practical framework for PI in RWDEG. The focus will be on diversity and inclusion and will use data driven personas to ensure a range of representative views.

CONCLUSIONS: Given the many differences in personal characteristics and health conditions and the contextual differences of conducting real-world as opposed to clinical research, we aim to develop a publicly available framework that incorporates behavioural science principles, and provides clear understanding of the value proposition from a patient’s perspective regarding how they would like to contribute to, use and access real-world data and evidence across the medicines development lifecycle.