Clinical Trials Results Reporting and Dissemination

2:00 PM - 3:20 PM

Patient/patient groups perspective

Top-line description of the main issues from a medical writing point of view on protocol synopsis (lay language), lay summary of clinical trials results Lisa Chamberlain James

Explanation why these documents are important for patients – what they use them for, and why it’s worth our time and effort to write them well Jan Geissler

The disclosure of results of clinical trials in scientific publications is governed by multiple regulations and guidelines, such as, ICMJE, CONSORT, GPP, and other industry codes of conduct. We will discuss how the newest EMA regulation is influencing scientific publications development from the study sponsor, as well as scientific journal perspective. John Gonzalez and Priti Nagda