Unveiling Insights: Navigating the Public Disclosure of Clinical Trials in an Evolving Industry

Description: The introduction of clinical trial registries such as clinicaltrials.gov and EudraCT ushered-in the era of clinical trial transparency, and in recent years the environment has evolved significantly, with a myriad of national clinical trial registries being established to provide similar information to those pioneering databases in a range of languages and formats. In recent years the EMA in the EU and some other agencies such as HealthCanada have aimed to further enhance the levels of information being released, to provide greater visibility to patients, researchers and the scientific community as a whole. The aim of promoting greater public engagement in the information relating to the drugs they are taking as trial participants or following authorisation of the medications is truly admirable, and promises great benefits for all clinical trial stakeholders, if that greater engagement translates into greater awareness and participation in clinical trials. At the same time, the rapid implementation of these changes has introduced significant challenges for researchers and clinical trial sponsors. During this session we will discuss the changes, the steps taken by agencies to create a framework within which clinical trial sponsors and researchers can protect commercially sensitive information and prevent the inappropriate release of personal data. The rapidly evolving environment hasn’t made this an easy journey for the clinical and regulatory teams of trial sponsors, and we will aim to share insights in this session to help the audience understand how these challenges have been navigated in both an EU and global context.