Sponsors to Assess Role of Drugs in Adverse Reactions in Trials

Sponsors reporting suspected unexpected serious adverse reactions (SUSARs) from clinical trials in Europe will have to include an assessment of any drug that may have played a role in the event, according to a final guidance by the European Medicines Agency (EMA). The requirement, which will take effect Feb. 7, applies to individual case safety reports submitted prospectively to the EudraVigilance Clinical Trial Module. In requiring causality assessments for all reported drugs classified as suspect or interacting, the EMA hopes to identify reactions related to the investigational drug and enhance the monitoring of SUSARs.
Clinical Trials Advisor