It’s been more than 6 years since our last Medical Writing edition dedicated to clinical trial transparency and disclosure. Since then, we have seen the full implementation of the long-awaited EU Clinical Trials Regulation (CTR), the pause and restart of EMA Policy 0070, and of course a global pandemic which resulted in a world-wide surge in freedom of information requests for Covid-19 vaccine clinical trial data. Although many of the regulations and policies governing public disclosure of clinical trial data and documents remain unchanged, we have seen significant changes in the way these are implemented. As those of us who work in this field know all too well, the landscape is ever changing, and it is essential to keep up to date with those changes. Resources such as the Drug Information Association Clinical Trial Disclosure Community, PHUSE Data Transparency Working Group, and Clarity and Openness in Reporting-E3 based (CORE) Reference provide invaluable updates and insights. This issue of Medical Writing touches on a number of different aspects of clinical trial transparency and disclosure, all of which involve medical writers as key stakeholders.

Medical Writing. 2024;33(3):2–4. https://doi.org/10.56012/gkvo3717