Episode 268
What is the ASAP and what you should know about it
Interview with Greg Ball
The Effective Statistician - in association with PSI · Alexander Schacht and Benjamin Piske
January 9, 202329m 4s
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Show Notes
Interview with Greg Ball
- The US FDA has been advocating for aggregate program-level safety evaluations since 1988 when the ISS was introduced (the IND Safety Reporting Final Rule).
- Aggregate data analysis looks at all available data holistically rather than relying on individual case reports. This allows for a more complete understanding of potential risks associated with a drug or vaccine.
- In the near future, more companies will adopt a systematic approach to aggregate safety assessment planning and IND safety reporting.
- This process will develop a better understanding of the safety profile of drugs and ensure that patients' safety is well-thought-of.