What does the acronym TESS stand for in the context of clinical trials?

The acronym TESS stands for Treatment-Emergent Signs and Symptoms. In clinical trials, this term is used to describe any new symptoms or changes in a patient’s condition that occur after the initiation of treatment, which may be attributable to the intervention being studied. These signs and symptoms are critical for evaluating the safety and tolerability of a treatment, as they can provide insights into potential adverse effects or reactions associated with the drug or therapy under investigation.

Identifying and documenting treatment-emergent signs and symptoms is essential for understanding how a treatment impacts participants, ensuring that researchers can assess the overall safety profile of the treatment. By monitoring these indicators, trial sponsors can make informed decisions about the continuation or modification of the study and can better inform regulatory bodies and stakeholders about the treatment's risk-benefit profile.