Safety Analytics Workshop
Computational Science Symposium, June 2019

A Safety Analytics workshop was held at the PHUSE Computational Science Symposium event in June 2019. The workshop discussed recommended tables and figures, and covered common pitfalls and questions when analysing safety data from clinical trials. The session was recorded and is available for public review, together with the presentation slides shared on the day. If you are involved with planning, programming, or interpreting safety data from clinical trials, please review the slides and/or listen to the recording. This workshop is part of a crowdsourcing effort to improve cross-functional safety analytics expertise across the industry.  

Please click the image below to view the full Safety Analytics Workshop presentation slides by Mary Nilsson:

As well as the following video links for the session recordings and video playlist of the workshop:

About PHUSE: PHUSE – Pharmaceutical Users Software Exchange – is an independent, not-for-profit organisation run by volunteers. Since its inception, PHUSE has expanded from its roots as a conference for European statistical programmers to a global membership organisation and platform for the discussion of topics encompassing the work of data managers, biostatisticians, statistical programmers and eClinical IT professionals. More information can be found on the PHUSE Website

About the FDA/PHUSE Computational Science collaboration: The FDA partnered with PHUSE in 2012 to create a Computational Science collaboration. The mission of the collaboration is to provide an open, transparent forum in a non-competitive environment in which academia, regulators, industry, technology providers and others can address computational science needs in support of health product development and regulatory review, ultimately bringing safe and effective medical products to those who need them. While the collaboration was initially formed between PHUSE, the FDA and industry, it has been extended across other regulatory agencies and stakeholders. More information can be found on the Working Groups section of our website.

About the Analysis and Display White Papers project team: The Analysis and Display White Papers project is an ongoing initiative in the Standard Analyses & Code Sharing PHUSE Working Group. It delivers recommendations on the analysis and reporting of data that are common across therapeutic areas, including demographics, subject disposition, safety assessments (adverse events, labs, vital signs), pharmacokinetics and special topics like hepatotoxicity and thorough QT analyses. Over ten white papers are at various stages of development, including six that have been finalised. This project provides an organised platform for shared learning of improved methodologies (including visual analytics) that can lead to earlier safety signal detection, better characterisation of the safety profile of compounds, and improved efficiency. Final white papers from this project team, and other project teams from the FDA/PHUSE Computational Science collaboration, can be found on the PHUSE Working Group page.

We would be grateful if you could help share this workshop across your organisation.


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