Announcing a series of webinars showcasing our 2024 Trials Adverse Event Special Series. Over the course of 2025 we have a range of talks lined up covering trial conduct, analysis, reporting, and public involvement. Please register your interest here:

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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.

Catch up on today's adverse event webinar here:

Suggesting that core harm outcomes along with serious, related and unexpected adverse events (SAEs, SARs, SUSARs), any pre-specified events, and events that lead to discontinuation of the treatment should always be reported. Seems there is still lots of room for improvement.

This highlights there's still a need for an agreed consensus on what should be reported in journal articles. @VR_Cornelius called for this in their 2022 JCE article

- And when AE data was complete, discrepancies in 38% of SAEs, 86% of OAEs, and 36% of mortality outcomes.

Eeek this makes for a grim read. - Serious AEs (SAEs) and other AEs (OAEs) results omitted in 14% and 9% of articles, respectively.- All-cause mortality missing in over 1/3 of articles.

Read the full article here:

This work serves as a guide for academics and professionals, providing insights into the safety assessment required by regulatory bodies when a clinical investigation of a #DMHI is proposed, with methods, scales and tools that can be adapted for use in other similar research.

Catch up on today's #AdverseEvent special series webinar: We heard from Rayan Taher & Jenny Yiend about their work on developing a process for assessing the safety of a digital mental health intervention (DHMI) & gaining regulatory approval.

You can also find the full publication here:

On June 5th we host our 4th webinar in our adverse event special series. Rayan Taher & Jenny Yiend will present their work on developing a process for assessing the safety of a digital mental health intervention & gaining regulatory approval. Register:

RT @stats_ci: 📢Job alert! We are looking for an ambitious senior trial statistician to join an exciting new partnership between Imperial Co….

- Andrew Bruce sharing his perspective of collecting and reporting adverse events in vaccine trials in the Gambia. With many more to come over the course of 2025!.

You can here from: . - Regina Stegherr discussing the SAVVY project which aims to improve the analyses of adverse events in clinical trials using survival methods to handle varying follow-up & competing events.

Catch up on all the talks from our Adverse Event special series so far:

RT @MarionKCampbell: In clinical trials it is not only potential benefits that should be measured - it is crucially important that any pote….

Read the original paper here:

May 22nd we host our third webinar in our adverse event special series. Regina Stegherr will be discussing the SAVVY project which aims to improve the analyses of AEs using survival methods to handle varying follow-up & competing events. Register here:

Collectively the articles indicate the scope of research needed for robust evaluation and inference, and how the whole pathway from collection to final inference needs careful attention.