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Industry has been asking a lot of questions lately about Elsa (see a great example from Martin Lush).  Why is the FDA rushing in?  I think that they are trying…

A special challenge in ongoing aggregate evaluation of safety data is application of appropriate statistical techniques that account for clinical considerations, as opposed to strict statistical inference.  Exploration and estimation

Clinical trials (in geClinical trials (in general) are designed/powered for efficacy analyses; however, there are important differences between efficacy analyses and safety assessments.  Consequently, we are moving away from adherence

John Tukey – the Father of Data Science – recognized a problem brewing back when we were just starting to develop the most powerful tests for efficacy analyses, soon after

EU and US regulators have been strengthening requirements for aggregate safety assessments throughout development.  However, emphasis has been different, with the EU more focused on postmarketing surveillance and the US

Regarding the IND Safety Reporting final rule, the FDA does not want to be too prescriptive concerning thresholds and approaches; however, they note that these reviews focus on a tiny

The FDA IND Safety Reporting final rule highlights the importance of aggregate analyses for determining reasonable possibility of an association with study drug for serious adverse events.  Clinical safety professionals

More from the FDA Focus Group I attended in 2016, regarding how companies become aligned with the spirit of the IND Safety Reporting final rule… There is a preference, mostly

My previous blog summarized KOL views (in 2016) of the state of drug safety quantification in our industry.  As part of the KOL interviews, there was an FDA focus group

When I established the ASA Biopharm Safety Monitoring Working group in 2015 (with Bill Wang), one of the first things that we did (with Susan Duke and Mac Gordon) was