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 to this new way of thinking about safety assessments and safety data science.
Safety assessments are different from efficacy analyses. There are important subgroups, dose relationships, and other clinical considerations for safety. Ignoring these considerations results in mischaracterization of the safety data. To prove efficacy requires a testing and confirming approach. Safety assessments, on the other hand, require a learning and decisionmaking approach – a scientific evaluation of the data to understand, characterize, and communicate the safety profile.
To leverage the scientific expertise and medical judgment of the multidisciplinary Safety Management Team (SMT), we need:
- A multidisciplinary approach
- Assessments are product-specific
- Quantitative frameworks: measures of evidence in the data
- Decisions that are driven by medical judgment
Interpretational emphasis should be on medical judgment.