MHRA guidance on the use of real-world data in clinical studies to support regulatory decisions

The MHRA launched a 6-week consultation in October 2020 on draft guidance for randomised controlled trials generating real-world evidence. Following analysis of stakeholder responses, two guidelines were published: one providing an introduction to using real-world data and another outlining points to consider when planning a prospective randomised trial using RWD sources with regulatory decision intentions. These documents aim to support clinical studies and trial authorisation in the UK.