The 2021 IND safety reporting guidance highlights the importance of maintaining a Safety Surveillance Plan (SSP) that describes the approach for monitoring serious anticipated events requiring aggregate analysis. Decisionmaking for…
The ASAP Process supports the Safety Surveillance Plan Read More »
A Learning and Decision-Making Approach PhRMA SPERT proposed three tiers (classifying endpoints by analysis) for analyzing AEs. An alternative approach is to think of two parts (classifying endpoints by clinical
A Learning and Decision Making Approach Read More »
In 2005, CIOMS VI (Management of Safety Information from Clinical Trials) started to bridge the gap between pre- and post-approval activities to understand and manage risk. Pharmacovigilance had traditionally focused
The ASAP Process Builds on CIOMS VI and the PSAP Read More »
EU regulators prefer to receive all individual SUSAR reports from sponsors (judged by sponsor and/or investigator) – concerned about missing important signals. Note, Reference Safety Information (RSI) listed in the
Regaining Global Alignment on Safety Reporting from Clinical Trials Read More »
Recent guidance on safety monitoring during drug development, issued by regulatory authorities in the US and EU, indicate a shift in focus toward aggregate safety monitoring and scientific evaluation of
Global Regulatory Landscape for Aggregate Safety Assessments Read More »
To meet the spirit of the IND safety reporting final rule, sponsors have developed processes and procedures to evaluate, assess and act on accumulating safety information during development on an
When Quant Is Not Enough Read More »
Interdisciplinary safety evaluation is needed for learning and decision-making, for understanding the evolving product safety profile, and for ensuring effective risk management strategies. We need a framework for safety evaluation
Interdisciplinary Safety Evaluation Read More »
The ASAP Process is medical judgment within a quantitative framework. I would like to thank Joe Heyse (my mentor), and through him John Tukey (Joe’s mentor), for opening my mind
Medical Judgment within a Quantitative Framework Read More »
The call for program‐level reviews of accumulating safety data, including from ongoing studies, provides an opportunity to leverage the scientific expertise and medical judgment of safety management teams. A multidisciplinary
Partnership between Clinical and Statistical Scientists Read More »
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 »
