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PhUSE Nonclinical Subteam Update

The goal of the PhUSE Nonclinical Subteam is to leverage actual nonclinical and clinical electronic data to better understand how nonclinical toxicity data can forecast clinical effects or adverse events. Key accomplishments include the creation of a rudimentary database of past and present efforts in Endpoint Predictivity and delivery of two simple use cases for examining available databases. Challenges faced include delays in accessing FDA data and tools. Moving forward, recommendations include continued progress evaluation and exploration of new topics for Working Group 6.

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PhUSE Nonclinical Subteam Update

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  1. PhUSE Nonclinical Subteam Update Endpoint Predictivity

  2. Endpoint Predictivity • Goal • Use actual nonclinical and clinical electronic data to increase our understanding of the ability to use nonclinical toxicity data to predict clinical effects or adverse events • Accomplishments • Created a rudimentary database of present and historical efforts related to Endpoint Predicitivity • Delivered two simple use cases for interrogating available nonclinical and clinical databases • Challenges • Access to FDA data and tools did not become available in a timely fashion • Recommendations • In light of progress to-date, how shall the group continue?

  3. Topics for future work • Please provide additional topics for Working Group 6. • Topics may have evolved from your team’s work or may be entirely new topics which are unrelated to your current efforts.

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