Preclinical Suicidality Working Group

Due to the recent regulatory guidelines issued around the inclusion of prospective suicidality assessments in clinical trials, questions have arisen surrounding the ability to detect treatment-emergent suicidality preclinically. This working group of industry scientists was formed in order to provide an expert assessment of the science of preclinical evaluation of treatment-emergent suicidality.

The goals of this working group are to 1) evaluate current science and assays as to the value in predicting and interpreting clinical suicidality,
2) identify and evaluate the design, performance, and endpoints of selected tests/assays when conducted with products that have an apparent association with suicidality and 3) summarize conclusions of the status of preclinical evaluation and predictivity of clinical suicidality.