Clinical Data Safety Analysis

This work is project managment support for BIRRS activities such as the Standard Safety Tables and Figures, FDA Medical Queries, and OND Safety Analytics Office Hours. The project managment support provided by contractors will enable the delivery of multiple resources to reviewers across OND and promote standarization across the office. This request includes additional support, including training for safety analytics tools. The BIRRS team develops clinical informatics projects in support of OND clinical reviewers such as the FDA Medical Queries (FMQs) project which is designed to promote safety signal detection clinical trial data analyses for marketing applications. These projects frequently require computer programing and informatics expertise to identify best solutions or test potential options using large clinical trial data sets. This use case will provide this type of support, as well as the computer programming expertise needed to maintain and enhance existing tools such as the FMQ Browser. Requested funds will be used to maintain and improve exisiting FMQs and the dashbord for enhanced user experience, develop additional algorithmic and standard FMQs.Leverage AI/ML/data analytics to explore trial data in support of the development of informatic tools and solutions. Such work will include assessing variables related to drug effects on liver to support regulatory guidance work, and the generative AI pilot project that is investigating the ability of large language models to answer questions regarding the contents of FDA Guidance documents. Additional AI work may include other safety analytic related initiatives such as the development of classifiers trained on safety reports and used to assess the likelihood of an adverse event being caused by a medication based on the information provided in a case narrative, or tools that predict the likelihood of a medication