|Project Title||2017 ICPE Workshop: TreeScan™: A Novel Data-Mining Tool for Medical Product Safety Surveillance|
Saturday, August 26, 2017
Background: The tree-based scan statistic -- operationalized in freely available TreeScan™ software -- anchors a statistical signal detection approach to evaluate unexpected potential associations between exposures and outcomes of interest in electronic healthcare data. The approach takes advantage of the hierarchical nature of clinical concepts, including clinical outcomes and medical product exposures. Investigators can collect and analyze data on several thousand outcomes, or exposures simultaneously, while formally controlling for multiple hypothesis testing.
Objectives: This workshop will teach the theory of tree-based scan statistics, describe recent efforts by the U.S. FDA in using TreeScan™ for routine safety surveillance, demonstrate how to use TreeScan™ software, and then allow audience members to detect signals that have created by manipulating a simulated dataset. Investigators that seek to apply the TreeScan™ method to their own database sources will benefit from attending.
Description: The workshop agenda follows:
Judith Maro, Rima Izem, Martin Kulldorff, Azadeh Shoaibi
- Vaccines, Blood & Biologics
- Devices and Radiologic Health