It used to be standard practice in clinical studies to make this assumption, for the patient benefit. “So and so experienced a Serious Adverse Event while on study.”
“Did we find a root cause?” “No.”
“Discontinue until we can rule our product out as a cause.”
It used to be standard practice in clinical studies to make this assumption, for the patient benefit. “So and so experienced a Serious Adverse Event while on study.”
“Did we find a root cause?” “No.”
“Discontinue until we can rule our product out as a cause.”
Discontinue the study, or looking for the cause of death?