Safety Analytics Education
Project Description |
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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. |
Project Leads | Emails |
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Christopher Smith, FDA | |
William Palo, (Volunteer) | |
Nicola Newton, PHUSE Project Coordinator |
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