Clinical Researchers Eager for Launch of Enhanced AERS

Clinical trials professionals hope the FDA will have a new adverse event reporting system (AERS) in place before the end of next year to help streamline the reporting process, which has become increasingly onerous for researchers.

Industry representatives have already sent the FDA proposals on how the existing AERS system can be improved, according to Ernie Prentice, chair of the HHS' Secretary's Advisory Committee on Human Research Protections. Prentice, who spoke at the recent Association of Clinical Research Professionals annual meeting in Orlando, Fla., said he hopes the FDA will launch a new AERS within the next 18 months.

Many research facilities and institutional review boards have become overwhelmed with adverse event data -- some to the point where it's difficult to differentiate between serious and less-serious reports. To make matters worse, neither the FDA nor the Office of Human Research Protections have provided clear guidance on event report handling, clinical experts contend.

A revamped AERS could help in detecting defects and problems with pharmaceuticals and medical devices before they reach the market, clinicians say. This could, in turn, help prevent embarrassing situations for the FDA and the industry, such as the postmarket adverse event reports that detailed troubling cardiovascular side effects associated with Cox-2 inhibitor Vioxx (rofecoxib), which was recalled by Merck last fall.