Safety Analytics – Project Volunteer Board
Welcome! |
|---|
Interested in joining one of the Safety Analytics Working Group Projects? The projects below welcome new volunteers. |
Project Description: This project produces two white papers providing recommendations for analyses and displays to assess hepatotoxicity in Phase II to IV clinical trials and integrated submissions. Stage 1 focuses on a standardised set of analyses and outputs to evaluate whether there is reasonable medical evidence to rule out potential drug-induced liver injury (DILI). Stage 2 addresses situations where DILI cannot be excluded, outlining additional analyses needed to further characterise the safety signal and assess causality. The project aims to improve consistency, transparency and efficiency in hepatotoxicity evaluation across the industry. As a value add, the team will also develop an open-source Hepatotox tool to support the generation of recommended analyses and outputs for both stages. This will enable practical implementation of the guidance and support more robust and reproducible safety assessments. | Regular Project Meeting Day/Time:
Key Skills:
|
Safety Analytics Education – Started Q1 2024 | |
Project Description: This project focuses on the development and delivery of education for clinical trial safety analyses, with an emphasis on Phase II to III studies. It addresses a recognised gap in formal training, where the scientific expertise required for planning, interpreting and communicating safety analyses is often limited across roles such as medical, statistics and medical writing. The initiative aims to improve the quality, consistency and understanding of safety analyses, enabling more efficient alignment on analysis plans and interpretation of results. As the field continues to evolve, ongoing education is essential to support best practices and informed decision-making. Building on existing efforts – such as PHUSE CSS workshops, collaborations with external organisations, a dedicated Safety Analytics Education website, and a webinar series – the project will establish a coordinated platform for future educational activities. This will enhance capability across stakeholders and strengthen PHUSE’s leadership in the safety analytics domain. | Regular Project Meeting Day/Time:
Key Skills:
|
Project Description: This project addresses the need for clear, practical processes for aggregate assessment of adverse event (AE) data during early clinical development, as encouraged by the FDA’s 2021 draft update to the Final Rule, which provides limited methodological guidance. The initiative will define approaches for AE assessment across development stages, recognising differences between early-phase studies and Phase III. It will establish consistent practices for grouping related preferred terms and align processes across analysis plans, SDTM/ADaM specifications, and output displays. The project will identify key challenges in detecting safety signals, evaluate appropriate analytical methods, and clarify important concepts such as “significance” in a clinical (non-statistical) context. It will also address limitations such as small sample sizes and uncertain background rates. Additionally, industry practices will be assessed through targeted surveys. The outputs will support more consistent, transparent and effective safety evaluations for both internal stakeholders and regulators. | Regular Project Meeting Day/Time:
|