Addressing barriers to sharing results with trial participants

Description:

While most trial participants want to find out the results of the studies they have taken part in, most never get to find them out. When study teams do share results, this is often done is a passive way (expecting participants to seek out results for themselves), and the information provided is often written for clinical or scientific audiences, rather than lay audiences. Funders have received feedback from their patient communities that participants are unhappy about not being offered study results. The forthcoming Clinical Trial Regulations in the UK will introduce a legislative requirement that trial findings are shared with participants in a suitable format (although this legislation will only apply to Clinical Trials of Investigational Medicinal Products (CTIMPs), rather than all trials).

During a workshop for UK trial funders, hosted by the MRC CTU at UCL in June 2024, participants discussed some of the barriers to sharing results with trial participants, and approaches that may help address these barriers. This document summarises this discussion, and signposts relevant resources and guidance. We plan to update the guidance as new resources become available. If you have any suggestions on resources to include, please contact a.south@ucl.ac.uk