Safety Analytics Eduction

Planning and interpreting clinical trial safety analyses demands scientific expertise that is often missing in educational curricula. The Safety Analytics field is dynamic and evolving, requiring continual learning. All the roles (for example, medical, statistics, writers) that collaborate on ongoing safety reviews, clinical study reports and integrated submission documents can improve their planning, content, execution, and communication of clinical trial safety analyses

Improving Safety Analytics Education will lead to better content, implementation, and understanding of clinical trial safety analyses. Additionally, when stakeholders are educated, less time is needed for aligning on analysis plans and data interpretations.

Although not a formal project yet, members of the Safety Analytics Education project team have been active in delivering and promoting educational content for a while:

• Leading safety analytics workshops at the PHUSE CSS
• Presenting at the Duke Margolis-FDA workshop on advancing premarket safety analytics
• Partnering with the PHUSE Education team to create and maintain a Safety Analytics Education website
• Hosting a webinar series on interdisciplinary safety evaluation for decision-making

Creating an education project team will provide a dedicated channel for future efforts and enhance the standing of PHUSE in the safety analytics space.