Journal de pharmacocinétique et thérapeutique expérimentale

Abstrait

Principles of causality assessment and sender?s comment: everyday challenges and possible solutions

Daniela Di Cosmo

Assessing the causal relationship between a drug (or IMP) and the adverse event occurred plays a crucial role in the safety reporting flow, and it can be seen sometimes as challenging as it depends on multiple key factors (such as: temporal relationship, pharmaceutical properties of the drug/IMP, knowledge of the event, just to mention some). Counfounding risk factors can be present as well as lack of important information that make more difficult such assessment. What to do in these cases?

How our choice impact the results? And what are the challenges in making a decision which should always be be risk-based, reliable and considering what it is already known about the company’s products, but also, what is possibly unknown yet.