Safety Analytics – Project Volunteer Board
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Interested in joining one of the Safety Analytics Working Group Projects? The projects below welcome new volunteers. |
Project Description: This project will produce 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:
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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:
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Best Practices for Informing Benefit-Risk and Communicating Safety Information | |
Project Description: Recent advances in analysing and reporting clinical trial safety data have not yet led to clearer communication of safety profiles in prescribing information. Adverse drug reactions are often presented as simple percentages without sufficient context on timing, exposure, severity, reversibility, background risk, or clinical relevance, limiting informed benefit–risk decision-making. A landscape review explores drug safety communication, benefit–risk judgement under uncertainty, and decision-making safeguards used in other high-consequence fields. Findings suggest that many communication challenges stem from upstream decision-making issues, including poorly framed questions, hidden assumptions, value judgements, and insufficient challenge. These cannot be addressed through improved presentation alone. The project aims to enhance how safety information supports benefit–risk decisions by identifying ways to communicate safety findings more clearly, meaningfully, and transparently. It evaluates how safety data are summarised and contextualised to better reflect the underlying evidence and clinical relevance. The project also considers structured benefit–risk frameworks, estimands, and aggregated safety assessments across studies. Deliverables focus on practical communication principles, illustrative examples, and consensus recommendations that stakeholders can apply directly. | Regular Project Meeting Day/Time:
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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:
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