Statistical methods for safety monitoring in drug development



The Statistics and Data Science Community are pleased to announce the first virtual journal club of 2021 on statistical methods for safety monitoring in drug development.

Our speakers will include:
Dr. Emily Goren
Bayesian Meta-analysis of Safety Outcomes Using Blinded Clinical Trial Data by Emily Goren et al, TIRS 2020 Vol. 54, 1557-1565;

Dr. Shihua Wen
Quantitative Safety Monitoring in Clinical Trials: Application of Multiple Statistical Methodologies for Infrequent Events by Jiabu Ye et al, TIRS 2020 Vol. 54, 1175-1184, in collaboration with Dr. Jiabu Ye.

The discussant will be
Dr. Lei Nie, the Acting Associate Director of Statistical Policy, Office of Biostatistics, CDER, US FDA.

To register for this event please follow this link:

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Instructions for non-DIA Member interested meeting attendees: To join our meeting, you do not need to be a DIA member, but you do need a DIA login. Before the meeting starts, please create a DIA account, and log in to the DIA Communities at After you’ve logged in, join the Medical Writing Community (link here) to make sure you can watch the call.”

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