Trial Summaries Improving Patient-Centric Communications

Last updated: OCT 23, 2025

Executive Summary

Clinical trial sponsors continue to be faced with numerous challenges as they work to improve patient education and engagement throughout the clinical research process. These interactions have a direct impact on a trial participant’s perception of the care they are receiving in a clinical trial as well as their overall satisfaction with the experience.

Pressure to improve communications and to expand transparency efforts continues to come from trial participants, patient advocates, researchers and industry transparency advocates. As the complexity of clinical research continues to grow, so does the need to communicate more efficiently and effectively with trial participants and the general public.

This paper discusses the challenges inherent in the current practices of providing trial results summaries to trial participants. It presents an alternative approach to distributing trial results summaries that takes advantage of commonly used technologies to more quickly, efficiently and reliably provide trial results summaries to trial participants. The benefits of this approach to clinical trial sponsors, patients, and their relationship with each other are also discussed.

Introduction

Trial results summaries, often referred to as plain language summaries, are brief explanations of an individual clinical trial written in easily understandable language. Trial results summaries differ from the information typically posted on ClinicalTrials. gov or the EU Clinical Trials Register in that the information is less technical and geared toward a different audience. The objective of a trial results summary is to effectively communicate pertinent information in a clinical trial including the trial population, investigational medicinal product and the overall results. The audience for this document is primarily trial participants; therefore, the language used should be non‐ technical in nature and easy to understand.

Trial sponsors are increasingly focused on patient engagement, with a growing understanding that sharing results of clinical studies with the trial participants is the ethical thing to do. In addition to the evolving transparency policies, plain language trial results summaries are required by law in certain regions. The European Clinical Trial Regulation (EU No. 536/2014) requires sponsors to provide a clinical trial results summary that will be published in an EU‐wide database. Annex V of the regulation provides an outline for the content of the trial results summary as noted below.