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Decision Framework for Assessing Safety in Clinical Development Programs

Greg Ball, Ph.D, ASAP Process Consulting
October 18, 2023 (SDP Invited Talk)

Abstract: There has been general agreement with the spirit of the FDA IND Safety Reporting Final Rule (which was published in 2010):

To improve the overall quality of safety reporting and to comply with requirements for IND safety reports based on data in the aggregate, the sponsor should have in place a systematic approach for evaluating the accumulating safety data. Sponsors should periodically review accumulating safety data collected across multiple studies (completed and ongoing), analyze the data in the aggregate, and make a judgment about the likelihood that the drug caused any Serious Adverse Events (SAEs).

"The important thing is to have a thoughtful process; a system in place to look for clinically important imbalances, applying the best clinical and quantitative judgment, while maintaining trial integrityā€¯, - Jacqueline Corrigan-Curay (Principal Deputy Center Director | CDER | FDA)

 Operationalizing it has been rather challenging. Greg will discuss how industry and the FDA have aligned (Ball et al, 2021) on a learning and decision-making approach that uses medical judgment within a quantitative framework; scientific evaluation of accumulating program-level safety information throughout product development, leveraging scientific expertise and medical judgment of multidisciplinary teams:

A multidisciplinary approach
Assessments customized for the specific product
Quantitative frameworks for measuring evidence of association
Decisions that incorporate medical judgment

Click on the file below to hear a sample of the presentation.  

 Click here for access to the full video.

SDP membership is required for access to this webinar.

 Keywords: framing framestruc, medical decisions meddec, clinical trials

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