Analytical Framework for Safety Assessment Committee (SAC) in Drug Development

• Activity Number: 123 - Topics for the Statistician Clinical Trialist
• Type: Contributed
• Date/Time: Monday, July 31, 2017 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Amit Bhattacharyya* and Jonathan Seltzer
• Companies: ACI Clinical and ACI Clinical
• Keywords: FDA ; pharmaceutical drug ; Safety ; statistical methodologies ; Safety Assessment Committee ; aggregated data

Abstract

The FDA released a DRAFT guidance in Dec 2015 suggesting creation of a Safety Assessment Committee (SAC) for a drug development program. The committee will review safety data at the program level of the investigational drug and other relevant safety information outside of the program to make a judgment about the likelihood that the drug could cause serious adverse events. This will help the drug developer to streamline the safety reporting requirement from FDA so that only the unexpected suspected adverse events get reported to the agency. In addition to the medical and clinical aspects of evaluating safety at the program level, statisticians could develop an analytical framework for analyzing aggregated safety data from ongoing and completed clinical trials from the sponsors, external trials in the same disease area and/or treatment classes and epidemiology studies. This presentation will discuss some of the potential statistical methodologies that could be utilized to provide a threshold above which the safety of the drug is suspected as a plausible cause of an unexpected serious adverse event. Some of the methodological and logistical challenges will also be presented.