The ‘Real world evidence’ workshop was held on 17 September 2015 as part of the Academy’s FORUM programme. It brought together ABPIparticipants from across industry, regulatory, academia and policy to explore the acceptability of real world evidence in regulatory and Health Technology Assessment (HTA) decision-making, aspirations for the use of this evidence in a regulatory context, challenges to the acceptability and steps to overcome these.

The report summarises the presentations and discussions from the meeting, which highlighted the potential of real world evidence to significantly impact how medicines are evaluated. Over the course of the day, several barriers to realising this opportunity were identified by participants including a requirement for further clarity from regulators and HTA bodies on the acceptability of real world evidence, the need for coordination and leadership in this area to provide direction, a shift in perceptions of real world evidence and standardisation of data capture and analysis.The workshop report can be downloaded here, and further information on the meeting can be found on the Academy’s policy project page.