Assessing Suicide Risk in Clinical Trials: The Patient Knows Best

Due to the potential risk for new treatments to induce suicidal ideation and behaviors (SIB), reliable and timely assessment of clinical trial patients is critical. To ensure patient safety, SIB should be assessed at screening, during baseline assessments, and throughout the treatment as well as during the follow up phases of the study.

This article reviews why and when SIB should be monitored, compares the different approaches to assessing SIB, and presents information supporting patient self-reported assessments as the preferred approach for detecting and monitoring SIB during clinical trials.

ERT_Assessing Suicide Risk_Applied Clinical Trials_January 2020