Reporting adverse events in gene therapy studies.

The reporting of adverse events occurring in gene therapy studies is currently under discussion. There are many agencies involved in the reporting of adverse events, often with reporting guidelines that are unique to each organisation. Guidelines differ according to the type of event (adverse event, adverse drug reaction, unexpected adverse drug reaction, serious adverse event and serious adverse drug reaction). While there is a move toward making guidelines more stringent in the US, there is concern that this will increase the number of reports of unrelated events, create confusion from a global perspective, and increase public concern needlessly.