The DIA Statistics and Data Science Community is pleased to announce that registration is open for the FREE webinar "Using BDRIBS to Support the Decision to Refer an Event to a Safety Assessment Committee for Unblinded Evaluation." This webinar will be held on 1st December 2022, 10:00 - 11:30 ET. To register for this event, please use the web address below:
https://diaglobal.zoom.us/webinar/register/WN_ghXbgILWTC6fsEiGj8os1A
Abstract
In June 2021, FDA issued a new draft guidance, Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessments for IND and Bioavailability/Bioequivalence Studies. This guidance recommends that for anticipated events, which occur in the study population regardless of study drug administration, IND reporting decisions be made based on aggregate data analyses. These analyses should be delineated in a Safety Surveillance Plan, which is recommended to be an appendix to a broader Aggregate Safety Assessment Plan for the product. In the FDA guidance, the “trigger approach” is cited as an option for monitoring serious adverse events (SAEs) in the ongoing clinical trials when there is adequate information to provide a good estimate of the background rate of the SAEs. With this approach, if the overall blinded analyses indicate the rate of events in the pooled treatment groups substantially exceeds the predicted rate, then the unblinded rates by treatment group should be reviewed by an assessment entity firewalled from the study team. The Bayesian Detection of potential Risk using Inference on Blinded Safety data (BDRIBS) method has been previously described (2018) and offers a quantitative approach for assessing blinded events. In conjunction with use of quantitative approach such as the BDRIBS method, a procedural workflow for blinded review of safety data by the safety management team should be established. In this webinar we will describe a workflow for which the quantitative review process is coupled with qualitative data evaluation in order to decide whether to escalate an event for unblinded review. We will demonstrate this workflow in conjunction with the BDRIBS method which has an associate R-Shiny application that allows for dynamic visualization and assessment.
- Presentation
- Barbara Hendrickson (AbbVie)
- Brian Waterhouse (Merck)
- Reaction
- Jacqueline Corrigan-Curay (FDA)
- Discussion
- Moderator: Greg Ball (Novavax)
- Barbara Hendrickson (AbbVie)
- Brian Waterhouse (Merck)
- Jacqueline Corrigan-Curay (FDA)