More emphasis has been placed on aggregate safety assessments to establish a reasonably possible causal association Regulators in the US and EU support a more systematic approach Proactive Safety Assessments…
Aggregate Safety Assessments for Learning and Decision-Making Read More »
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
Impact of FDA’s Elsa AI: Prediction Read More »
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
Re-Imagining Safety Evaluation Read More »
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
Ongoing Culture Changes in the Safety Landscape Read More »
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
IND Safety Final Rule: Necessity is the Mother of Invention Read More »
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
Partnerships for Aggregate Assessments: One Size Does Not Fit All Read 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
FDA Focus Group (2016) Why Traditional DMCs Need More Read More »
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
Findings: FDA Focus Group 2016, On Unblinded Safety Assessments Read More »
