Clinical Trial Drug Safety Assessment for Studies and Submissions Impacted by COVID-19

With the COVID-19 pandemic, thoughts have turned to how to address the impact of the virus and what measures need to be taken to suppress the affect it has had on clinical studies. In the last few weeks two papers providing analysis recommendations from clinical trials impacted by COVID-19 have been prepared by a cross-industry group and submitted to Statistics in Biopharmaceutical Research. 

PHUSE is happy to share pre-prints of these papers which can be accessed from arXiv.org where they have been posted with permission from the journal editors. The views expressed in these papers represent the views of the authors and not necessarily those of PHUSE. PHUSE has convened a task force to share experiences of how clinical data scientists across industry have tackled these issues, look out for more blogs over the coming weeks addressing this important topic.

Paper primarily pertaining to efficacy analyses: http://arxiv.org/abs/2005.10248
Paper pertaining to safety analyses: https://arxiv.org/abs/2006.05502

If you have any questions regarding these papers or PHUSE's COVID-19 Task Force Project, then please email workinggroups@phuse.eu

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Tags: COVID-19

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