A systematic review of models of patient engagement in the development and life cycle management of medicines.

There is currently no universally agreed code of practice for patient engagement (PE), and existing guidelines do not fully cover the scope across medicine development and subsequent life cycle management. This review conceptualises the meaning and summarises the current models of PE. A systematic literature review was conducted and analysed by thematic synthesis. Eight themes were identified as components of how to achieve meaningful PE, and five were identified for where to engage with patients in drug development. This review provides summative guidance for stakeholders intending to introduce PE and establishes a starting point for the development of a universal code of practice.