The Department of Anaesthesia and Perioperative Medicine at the Alfred and Monash University conducts large, independent Phase IV clinical trials to test the efficacy and safety of commonly used drugs. These ‘investigator-instigated’ or ‘public good’ trials are pragmatic, low-cost and carried out independently of drug companies.
As part of the trials, researchers report adverse events (AEs) and serious adverse events (SAEs). But the department’s researchers say ever-increasing and complex requirements from sponsors and ethics committees to report AEs and SAEs are duplicating reporting, thereby burdening researchers and causing a decrease in the uptake of research.
