Global SUSAR Distribution: Lack Of Regulatory Harmony Puts Trials At Risk

The lack of global regulatory harmonization undermines safety reporting efforts, putting patients at risk and adding millions of dollars to the cost of a trial.

We’ve seen at least 40 different approaches in terms of how countries handle SUSAR distribution—and it all changes regularly.

A SUSAR (Suspected Unexpected Serious Adverse Reaction) letter typically must be sent within 15 days of when a sponsor is notified of the event. “Typically” is the operative word here, because it varies not only by severity, but by regulatory agency.

For example, in Australia, they say, “Please, don’t send us those notifications straight after every event happens. We would just like to be updated every six months with a line listing.” In the U.S. we say that if the doctor thinks the drug caused the problem, but the sponsor company disagrees, don’t send out the notification.

Similarly, IRBs and ethics committees have varying requirements. Consider blinding. In 22 countries, the ethics committee requires unblinded data. That’s usually a separate, cumbersome, manual process carried out by another team at the pharma company.

All these activities must be precise and auditable. Sponsors need to demonstrate they sent the notifications to the correct person, that they received it and, in some cases, even that they acknowledged and understood it. That demands access to up-to-the-minute regulatory intelligence, which most sponsors lack.

It is difficult to conduct this global process correctly and the consequences of making mistakes are severe, including potential risks to patient health, regulatory repercussions, delays, or even having a trial shut down.