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Abstract:
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The December 2015 FDA Draft Guidance: Safety Assessment for IND Safety Reporting Guidance for Industry introduced the concept of a Safety Assessment Committee (SAC) to determine whether an adverse event should be designated for expedited IND safety reporting. To fulfil this purpose, the SAC needs to make an unblinded assessment. In order to maintain the blind to project team members while still utilizing their expertise and experience with the compound under study, blinded methods of signal detection are needed to help determine an appropriate time to convene the SAC to review unblinded safety information. In this presentation we will briefly describe alternatives being developed by some of the sponsor companies from the Biopharm Safety Monitoring Working Group, followed by a more in depth discussion of a novel Bayesian method for detecting risk using inference on blinded safety data. We will also present graphics to help teams interpret posterior probabilities of a risk. Examples will be offered and discussed.
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