Clinical study reports (CSRs) are standardized full reports of the protocol, results, and other pertinent details of clinical studies that are typically submitted by pharmaceutical companies to regulatory authorities, as part of the drug approval process. In this talk Jeffrey Aronson & Igho Onakpoya discuss their review that looked at how data from CSRs compare with data in published trial reports, highlighting how often the apparent benefits of pharmacological interventions are less impressive, and more information emerges about harms they can cause when using the CSR. Read the full papers here: https://www.biomedcentral.com/collections/cart

Inga Frantz & Nina Heinrichs discuss development of a comprehensive adverse event assessment tool based on their experiences in the RISE project, a multisite RCT that evaluated a parenting intervention for parents of children with increased levels of behaviour problems.

Rayan Taher & Jenny Yiend discuss their paper which outlines the steps needed to assess the safety of a digital mental health intervention and gain regulatory approval via the STOP trial case study

Regina Stegherr presents her paper: Survival analysis for AdVerse events with VarYing follow-up times (SAVVY): summary of findings and assessment of existing guidelines - https://doi.org/10.1186/s13063-024-08186-7

Introduction to the series and our first talk from guest editor Rachel Phillips on her paper on the public perspective on potential treatment intervention harm in clinical trials - https://doi.org/10.1186/s13063-025-08861-3

Andrew Bruce presents his paper on Collecting and Reporting Adverse Events in Low Income Settings: Perspectives from Vaccine Trials in The Gambia - https://doi.org/10.1186/s13063-024-08419-9