Impact of FDA’s Elsa AI: Prediction
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…
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Posts
Cross-Disciplinary Scientific Engagement in the Development of Quantitative Procedures for Aggregate Safety Assessments
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
Re-Imagining Safety Evaluation
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
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Ongoing Culture Changes in the Safety Landscape
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
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DIA Europe 2025 Presentation: Regaining Global Alignment on Safety Reporting from Clinical Trials
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
IND Safety Final Rule: Necessity is the Mother of Invention
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
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Partnerships for Aggregate Assessments: One Size Does Not Fit All
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
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FDA Focus Group (2016) Why Traditional DMCs Need More
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
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Findings: FDA Focus Group 2016, On Unblinded Safety Assessments
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
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The Four Pillars of Advanced Safety Analytics
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
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